Tag Archives: Summit Therapeutics Ridinilazole

Summit Therapeutics Doses First Patient in Global Phase 3 Clinical Trials Oral Antibiotic ridinilazole for C.difficile Infection Treatment

Summit Doses First Patient in Phase 3 Clinical Trials of Precision Antibiotic Ridinilazole for C. Difficile Infection

  • Trials Aim to Show Superiority of Ridinilazole Over Standard of Care Treatment Vancomycin
  • Health Economic Outcomes Included to Support Commercialisation

FROM PRESS RELEASE:

Oxford, UK, and Cambridge, MA, US, 13 February 2019 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic innovation, today announces it has dosed the first patient in the global Phase 3 clinical trials of its precision oral antibiotic, ridinilazole, for C. difficile infection (‘CDI’). The trials aim to show superiority of ridinilazole over the standard of care, vancomycin, in a measure that combines CDI cure and recurrence called sustained clinical response (‘SCR’). Ridinilazole achieved statistical superiority over vancomycin in SCR in a Phase 2 clinical trial.

“Starting our Phase 3 programme is an important milestone for Summit,” commented Mr Glyn Edwards, Chief Executive Officer of Summit. With positive results, we believe ridinilazole could be positioned as the drug of choice in the front-line treatment of CDI, which potentially provides patients with sustained cures and hospitals with compelling cost savings.”

“Ridinilazole is the trail-blazer in our growing pipeline of innovative product candidates targeting serious infectious diseases,” added Dr David Roblin, President of R&D of Summit. “Our Phase 3 programme exemplifies our broader strategy of demonstrating significant advantages over current standards of care by gathering a carefully considered package of clinical and economic data to address the needs of physicians, regulators, healthcare providers, payors and, above all, patients.”

The Phase 3 clinical programme comprises two global, randomised, double-blind, active-controlled clinical trials called Ri-CoDIFy 1 and Ri-CoDIFy 2. The trials will be run concurrently with each expected to enrol approximately 680 patients at sites in North America, Latin America, Europe, Australia and Asia. Upon confirmation of a positive CDI toxin test, patients will be randomised to receive either ridinilazole (200mg twice a day) or vancomycin (125mg four times a day) for ten days. The primary endpoint of both clinical trials will test for superiority in SCR, defined as cure at the end of treatment and no recurrence of CDI within 30 days post-treatment. Secondary endpoints include cure at the end of treatment and SCR at 60 days and 90 days post-treatment. Additional endpoints will evaluate the impact of ridinilazole and vancomycin on the gut microbiome, which is known to protect against CDI. The Phase 3 clinical trials also include health economic outcome measures, such as readmission rates and length of hospital stay, to help support the commercialisation of ridinilazole, if approved.

Top-line data from the Phase 3 programme are expected to be reported in the second half of 2021.

The clinical and regulatory development of ridinilazole is being funded in part with Federal funds from the US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (‘BARDA’), under Contract No. HHS0100201700014C. Summit is eligible to receive up to $62 million in funding from BARDA to support the clinical and regulatory development of ridinilazole.

About Ridinilazole
Ridinilazole is an oral small molecule new mechanism antibiotic that is designed to selectively kill C. difficile, thereby preserving patients’ protective gut microbiome and leading to sustained CDI cures. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In that trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. Ridinilazole was also shown to be highly preserving of the gut microbiome in the Phase 2 proof of concept trial, which was believed to be the reason for the improved clinical outcome for the ridinilazole-treated patients. In addition, ridinilazole preserved the gut microbiome to a greater extent than the marketed narrow-spectrum antibiotic fidaxomicin in an exploratory Phase 2 clinical trial. Ridinilazole has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include a potential extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics
Summit Therapeutics is a leader in antibiotic innovation. Our new mechanism antibiotics are designed to become the new standards of care for the benefit of patients and create value for payors and healthcare providers. We are currently developing new mechanism antibiotics for infections caused by C. difficile, N. gonorrhoeae and ESKAPE pathogens and are using our proprietary Discuva Platform to expand our pipeline.

For more information, visit www.summitplc.com

Summit Therapeutics Enters License and Commercialization Agreement with Eurofarama in Latin America to Summit’s Precision Antibiotic ridinilazole in Development for the Treatment of CDI

Summit Therapeutics —  the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection (‘CDI’), announces that it has entered into an exclusive license and commercialization agreement granting Eurofarma Laboratórios SA (‘Eurofarma’) rights in Latin America (the ‘Licensed Territory’) to Summit’s precision antibiotic ridinilazole in development for the treatment of CDI.

Summit retains commercialization rights in all other countries.

ridinilazole is a targeted antibiotic that has the potential as a frontline therapy to treat initial infection and preserve patients’ microbiomes to reduce the rate of recurrent CDI. In a Phase 2 proof of concept trial in CDI patients, ridinilazole demonstrated statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin.

ridinilazole is expected to enter Phase 3 clinical trials in the first half of 2018.

“Eurofarma’s established infrastructure and expertise in Latin America are ideally placed to commercialise our novel antibiotic, ridinilazole,” commented Glyn Edwards, Chief Executive Officer of Summit. “This agreement, combined with the recent contract award of up to $62 million from the US Government agency BARDA, will further support the Phase 3 clinical programme and regulatory development of ridinilazole. These partnerships endorse the potential of ridinilazole in the treatment of CDI, and move us a step closer to bringing this antibiotic to patients.”

Eurofarma is a multinational pharmaceutical company with headquarters in Brazil and operations in over 20 countries in South and Central America, the Caribbean and Africa. Eurofarma has a broad portfolio of products across multiple therapeutic areas including a focus in infectious diseases where it markets a number of antibiotics.

“CDI is a serious global healthcare threat including in Latin America,” added Martha Penna, P&D Vice-president of Eurofarma. “Through our interest in bringing innovative products to the region, we were impressed by the efficacy data from the ridinilazole Phase 2 programme and the differentiated profile of the drug. We believe it has the potential to address a major unmet need in CDI, and we look forward to working with Summit to bring ridinilazole to market for the benefit of patients.”

Under the terms of the licence and commercialisation agreement, Summit will receive an upfront payment of $2.5 million, and is entitled to receive a further $3.75 million in development milestones upon the achievement of staged patient enrolment targets in the planned Phase 3 clinical trials of ridinilazole. Summit is eligible to receive up to an additional $21.4 million through other development milestones, commercial milestones, and one-time sales milestones based on cumulative net sales up to $100 million in the Licensed Territory. Further, the agreement provides for product supply transfer payments expected to provide a return equivalent to a high single digit to low double-digit percentage of net sales. For each incremental $100 million in cumulative net sales achieved, Summit is entitled to a further milestone payment which, when combined with the aforementioned product supply transfer payments, is expected to provide a return equivalent to a mid- to high-teens percentage of net sales.

Eurofarma will be responsible for obtaining regulatory approval for ridinilazole in the Licensed Territory. Summit retains full responsibility for the clinical development of ridinilazole in all countries, and is responsible for obtaining regulatory approvals outside of the Eurofarma licensed territories.

A Form 6-K will be filed with the US Securities and Exchange Commission (‘SEC’) that contains additional information about the terms of the licence and commercialisation agreement with Eurofarma.

A copy of this Form 6-K will be available to download either from the Investors section of the Company website at www.summitplc.com or from the SEC website at www.sec.gov.

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).

About Ridinilazole

Ridinilazole is a small molecule precision antibiotic that Summit is developing for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a targeted spectrum of activity that combined a potent bactericidal effect against all clinical isolates of C. difficile tested with minimal impact on other bacteria that are typically found in the gut microbiome. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In that trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. Ridinilazole was also shown to be highly preserving of the gut microbiome in the Phase 2 proof of concept trial, which was believed to be the reason for the improved clinical outcome for the ridinilazole-treated patients. In addition, ridinilazole preserved the gut microbiome to a greater extent than the marketed narrow-spectrum antibiotic fidaxomicin in an exploratory Phase 2 clinical trial. Ridinilazole, an orally administered small molecule, has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics

Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programmes focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

About the Eurofarma Group

As the first 100% Brazilian-owned multinational pharmaceutical company, Eurofarma has been in existence for 45 years, has 6,500 employees, and has operations in 20 Latin American countries. With 12 manufacturing plants in the region, the company has more than 280 products in its portfolio. In 2016, it produced more than 290 million units and reached revenues of R$3.3 billion, 15.7% higher than the previous year. The Group invests approximately 5.5% of its net sales in Research & Development and maintains a pipeline of more than 175 projects.

About Eurofarma Brazil

Considered one of the best companies to work for, Eurofarma Brazil is also considered the most sustainable pharmaceutical company in the country based on an analysis by the Exame Sustainability Guide. With operations in all main pharmaceutical segments including Medical Prescriptions, Generics, Hospital, Oncology, Veterinary, and Bids and Services to Third Parties, Eurofarma has the largest medical advertising salesforce in Brazil with more than 2,000 representatives that together perform 450,000 medical contacts per month. The company has the 4th largest pharmacy system in the country and has a portfolio of medicines that is the 2nd largest by prescription volume.

Global C. difficile Congress – Eight Sessions In Four Hours Webinar – A Half Day To Change the C. difficile World

worldworld

Raising global awareness with leading international topic experts have proven to be effective over the years with audiences attending our annual conferences.

 

The Global C. difficile Congress took place on November 11th, 2016 and broadened existing knowledge surrounding C. difficile infection (CDI)  prevention, treatments, research, and environmental safety worldwide.

The drive and passion takes us forward in promoting the practical and technical advancements taking place across the globe.  Healthcare Professionals from every area of expertise, discussed the control and  treatment options,  the healthcare perspectives, antibiotic-resistance stewardship programs, and much more to raise C. diff. awareness and share successful implementations and guidelines.

This free webinar is available to you and with the ease of learning without having to travel.

The Global C. difficile Congress  —  eight sessions presented by topic experts  – in four hours – in one day –  with goals to change the C. difficile world with a common focus; To
improve awareness of C. diff. infection prevention, treatments, research, and environmental safety in the healthcare communities worldwide.

 

https://recordings.join.me/ezyFo7graka6cXR8nmjkoQ

 

Guest Speakers and Program Topics

USA    ET                         UK TIME               GUEST SPEAKER

8:00 – 8:15 a.m.            1:00 – 1:15 p.m.       Paul Feuerstadt, MD

Dr. Paul Feuerstadt; Native of Long Island, New York, Dr. Feuerstadt attended the University of Pennsylvania where he earned his Bachelor of Arts degree in Biology, with distinction in research and graduated Summa Cum Laude. Following completion of his undergraduate training, Dr. Feuerstadt attended the Weill Medical College of Cornell University in Manhattan, New York where he earned his Medical Doctor degree and stayed at New York Presbyterian Hospital/Weill Cornell medical center for his internship and residency in Internal Medicine. Following completion of his residency
Dr. Feuerstadt then moved on to the Montefiore Medical Center in the Bronx, NY for his clinical fellowship training.His areas of interest include ischemic diseases of the gut and chronic diarrheal syndromes with a specific focus on C.diff. infections.Dr. Feuerstadt is affiliated with St. Raphael campus of Yale-New Haven Hospital, Yale-New Haven Hospital and
Milford Hospital seeing outpatients in his offices in Hamden and Milford, CT
Topic: Welcome – Introduction

8:15 – 8:45 a.m.            1:15 – 1:45               Jean de Gunzburg, PhD

Dr. de Gunzburg is Chief Scientific Officer of Da Volterra, an emerging biotechnology company, headquartered in Paris, France.  Prior to this, Jean de Gunzburg led an academic research career in molecular and cell biology at the Institut Pasteur (Paris, France), the Whitehead Institute for Biomedical Research (Cambridge, MA, USA) and the Institut Curie (Paris, France). He is the author of over 70 publications in international peer reviewed scientific journals, and continues to serve on several grant review committees.
Topic: “DAV132, A  Novel Product Destined To Prevent Antibiotic-Induced
Clostridium difficile Infections.”

8:45 – 9:15                   1:45 – 2:15                Arjun Srinivasan, MD

Dr. Arjun Srinivasan is the Associate Director for healthcare-associated infection (HAI) prevention programs in the Division of Healthcare Quality Promotion at the Center for Disease Control and Prevention’s National Center for Emerging and Zoonotic Infectious Diseases. Dr. Srinivasan is also a captain in the US Public Health Service. An infectious disease doctor, Dr. Srinivasan oversees several CDC programs aimed at eliminating healthcare-associated infections and improving antibiotic use. For much of his CDC career, Dr. Srinivasan ran the healthcare outbreak investigation unit, helping hospitals and other healthcare facilities track down bacteria and stop them from infecting other patients. Dr. Srinivasan leads the CDC’s work to improve antibiotic prescribing and works with a team of CDC experts researching new strategies.
Topic: Antibiotic Stewardship- Improving Antibiotic Use to Combat C diff.”

9:15 – 9:45                   2:15 – 2:45               Clifford McDonald, MD

Dr. McDonald graduated from Northwestern University Medical School. He completed a medical microbiology fellowship at Duke University and is a former member of CDC’s Epidemic Intelligence Service. Dr. McDonald is currently the Associate Director for Science in the Division of Healthcare Quality Promotion at the CDC. He has first authored or co-authored over 100 peer reviewed publications on subjects related to healthcare and infectious disease epidemiology Dr. McDonald joins fellow world-renowned topic experts to discuss the burden of C. difficile infections with the risk factors pertaining to current and emerging treatment options along with the importance of applying evidence-based clinical approaches to the prevention of  a C. difficile infection (CDI), one of the leading community and healthcare-associated infections.
Topic: “Challenges and Opportunities Posed by Current Diagnostics
for Clostridium difficile Infection”

9:45 – 10:15                 2:45 – 3:15               Barley Chironda,, RPN, CIC

Barley Chironda a Nurse, National Healthcare Sales Director and Infection Control Specialist Clorox Canada, Social Media Manager of IPAC Canada,  and the current President of IPAC- GTA.    Mr. Chironda is certified in Infection prevention and control (CIC™) and has worked extensively in Infection Control.  He is typically found engaged in motivating hospital staff, patients and the public on proper infection prevention practices.   Mr. Chironda’s roles allow great participation in quality improvement interventions related to patient and public safety. Therefore Barley has been an integral to the successful decline in Clostridium difficile infections through implementing innovative technology and quality improvement behavioral change.
Topic:  “The C.diff.. Disinfection Debate: To Use
Or Not To Use Sporicidal Disinfectants Every-Time In Healthcare Facilities.”

10:15 -10:45                 3:15 – 3:45              Dale Gerding, MD

Dr. Dale Gerding,  Professor of Medicine at Loyola University Chicago Stritch School of Medicine in Maywod, Illinois and Research Physician at the Edward Hines Jr. VA Hospital. Prior to his present position Dr. Gerding was Chief of Medicine at VA Chicago, Lakeside Division, and Professor of Medicine at Northwestern University Feinberg School of Medicine.  He is an infectious diseases specialist and hospital epidemiologist, past president of the Society for Healthcare Epidemiology of America and past chair the antibiotic resistance committee of SHEA.  He is a fellow of the Infectious Diseases Society of America and past Chair of the National and Global Public Health Committee and the Antibiotic Resistance Subcommittee of IDSA. He served as a member of the Board of Directors of IDSA from 2005-2008. He is a Master of the American College of Physicians and the 2013 recipient of the William Middleton Award, the highest research award given by the Department of Veterans Affairs. He is a member of the American Society for Microbiology, and is board certified in Internal Medicine and Infectious Diseases. His research interests include the epidemiology and prevention of  Clostridium difficile disease, antimicrobial resistance, and antimicrobial distribution and kinetics.  He has been a Merit Review funded research investigator in the VA for over 40 years and is the author of over 400 peer-reviewed journal publications, book chapters, and review articles.  He holds patents for the use of non-toxigenic C. difficile for the prevention and treatment of this disease.
Topic: “Non-toxigenic Clostridium difficile for Prevention of CDI”

10:45 – 11:15               3:45 – 4:15               Richard Vickers, PhD

Dr. Richard Vickers is the Chief Scientific Officer, Antimicrobials and Programme Lead for CDI,
Summit Therapeutics.  He joined Summit in 2003 and during his time has worked in a variety of roles involved in the development and management of various antibacterial therapeutic programs.  This includes leading the discovery and development of ridinilazole, the investigational antibiotic for the treatment of C. difficile infection. Prior to joining Summit, Dr Vickers undertook postdoctoral research studies with Professor Stephen Davies at the University of Oxford and held a Stipendiary Lectureship in organic chemistry at St. Catherine’s College in Oxford. Dr Vickers received a Ph.D. in organic chemistry from the University of Reading and a B.Sc. in chemistry from King’s College London.
Topic: “Ridinilazole; A Selective Therapy for the Treatment
of C. difficile Infections (CDI)”

11:15 – 11:45               4:15 – 4:45               Simon Cutting, PhD

Professor Cutting of Molecular Microbiology at Royal Holloway, University of London is a bacterial geneticist with over 25 years of experience with Bacillus since graduating from Oxford University with a D. Phil in 1986. His D.Phil was on understanding the genetic control of spore formation in Bacillus Clostridium difficile.. His other expertise is in the use of Bacillus spores as probiotics and has a number of contracts and consultancies with European and US companies in the food and feed sectors.
Topic: “Thwarting the Opportunist: An Anti-adhesion
Vaccine That Prevents C.difficult Colonization.”

11:45 – 12:15               4:45 – 5:15               Hudson Garrett, Jr, PhD

Dr. Garrett is currently employed as the Global Chief Clinical Officer for Pentax Medical. He holds a dual Masters in Nursing and Public Health, Post-Masters Certificate as a Family Nurse Practitioner, a Post-Masters Certificate in Infection Prevention and Infection Control and a PhD in Healthcare Administration and Policy. He has completed the Johns Hopkins Fellows Program in Hospital Epidemiology and Infection Control, and the CDC Fundamentals of Healthcare Epidemiology program, and is board certified in family practice, critical care, vascular access, moderate sedation, infection prevention, legal nurse consulting, and a director of nursing in long term care.  Dr. Garrett is also a Fellow in the Academy of National Associations of Directors of Nursing Administration in Long Term Care.
Topic:  “Improving Patient Safety and Reducing Clostridium difficile
through Collaboration with Clinical Nursing and Environmental Services Professionals”

 

For more information please visit the Global C. difficile Congress

http://www.globalcdifficilecongress.org

 

July 5th Join C. diff. Spores and More With Dr. Garey and Dr. Vickers As We Discuss Summit Therapeutics: Ridinilazole, a Microbiome Preserving Antibiotic For the Treatment Of C. difficile Infection (CDI)

 

Listen to the live broadcast

on  July 5th,  2016

cdiffRadioLogoMarch2015CLICK ON THE LOGO TO BE REDIRECTED TO THE  LIVE BROADCAST PAGE

Listen in to the live broadcast at 10a PT,   11a MT,   12p CT,   1p ET     6p UK


C. diff. Spores and More,”™ Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses

This Episode:  

Summit Therapeutics: ridinilazole, a microbiome preserving antibiotic for the treatment of a C. difficile infection (CDI)

With Our Guests:

Dr. Kevin W. Garey; Chair, Department of Pharmacy Practice and Translational Research Professor of Pharmacy Practice at the University of Houston College of Pharmacy, Houston, TX

Dr. Richard Vickers, Chief Scientific Officer at Summit Therapeutics

Join us as we discuss a promising and new treatment for a C. difficile infection.  Summit Therapeutic’s Ridinilazole, a microbiome preserving antibiotic will be introduced with updates with our  guests Dr. Kevin W. Garey, Chair, Department of Pharmacy Practice and Translational Research, Professor of Pharmacy Practice at the University of Houston College of Pharmacy, Houston, Texas and  Dr. Richard Vickers, Chief Scientific Officer at Summit Therapeutics

♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦

C. diff. Spores and More ™“ Global Broadcasting Network spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives,C. diff. survivors, board members, and C Diff Foundation volunteers who are all creating positive changes in the C. diff. community worldwide.

Through their interviews, the C Diff Foundation mission will connect, educate, and empower many worldwide.

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice HeZarPhotoWebsiteTop (2)ad for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of
Clostridium difficile disease and the need to stratify patients by disease severity.

To access the C. diff. Spores and More program page and library, please click on the following link:    www.voiceamerica.com/show/2441/c-diff-spores-and-more

Take our show on the go…………..download a mobile app today

http://www.voiceamerica.com/company/mobileapps

Programming for C. diff. Spores and More ™  is made possible through our official  Sponsor;  Clorox Healthcare

CloroxHealthcare_72

C Diff Foundation Shares a Community Of Clinical Studies In Progress Focused On Clostridium difficile (C.diff.) Prevention and Treatments Worldwide

Clinical Studies In Progress To Help You — Help Them — Help Others  ♥

Every scientific research and development, every clinical trial in progress is a glimmer of hope………..HOPE for clinically safe and approved avenues to prevent and treat a
C. difficile infection
.

For More Information — Visit The ClinicalTrials.gov Website

https://clinicaltrials.gov/

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Learn more About Clinical Studies and About This Site, including relevant History, Policies, and Laws.

 

Listed below you will find information pertaining to organizations who have active clinical trials in progress.  Click on each organization’s website listed to review their clinical trial study opportunities — Inquire if you or your loved one qualify to participate in their study. 


*Please note:  The C Diff Foundation does not endorse any products and/or clinical study in progress. All website postings are strictly for informational purposes only.

……………………………………………………………….

Here is a list of Clinical Trial Phases:

Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.

  • Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

Additional Resource Information on clinical trials can be found at http://clinicaltrials.gov/info/resources

♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦

  C. diff. Infection (CDI)_Prevention on the Horizon

SyntheticBiologics2016LOGO

Synthetic Biologics’ SYN-004 Phase 2b Proof-of-Concept Clinical Trial

 A global, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the ability of SYN-004 to degrade certain IV beta-lactam antibiotics within the GI tract to maintain the natural balance of the gut microbiome for the prevention of C. difficile infection, C. difficile associated diarrhea and antibiotic-associated diarrhea in patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone.

Click here to see if there’s a study site in the U.S. near you and if you’re eligible.

Click here to learn more about SYN-004.

Updated: 4/14/2016

………………………………………………………………………

On March 1, 2016: Cdiffense Phase III Trial updates discussed with Doctors of Sanofi Pasteur To listen to the Podcast ~ Click on the Sanofi Pasteur Logo below and enjoy listening to the Sanofi Pasteur “Cdiffense” clinical updates.

SANOFI_Pasteur_RVB

Sanofi Pasteur, one of the leading vaccine manufacturers in the world, is in the midst of its Phase III clinical trial called Cdiffense to study its investigational vaccine to prevent Clostridium difficile infection (CDI). The trial is now in more than 20 countries across 5 continents to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary, symptomatic CDI. The investigational C. diff vaccine is designed to produce an immune response that targets the toxins generated by C. diff bacteria, which can cause inflammation of the gut. The investigative vaccine ultimately may help prevent a future infection from occurring. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization or have had at least two hospital stays and have received systemic antibiotics in the past year. For more information on the Cdiffense trial, please visit www.cdiffense.org

For more information, visit www.cdiffense.org

 WATCH this video to learn more about Clostridium diffiicle and Cdiffense

https://youtu.be/IPunIvOaurA

—————————————————————

DAV-Logo (2)

Da Volterra is a biopharmaceutical company, privately-held and headquartered in Paris (France), focused on the discovery and development of innovative therapeutic and preventive products for Clostridium difficile and multi-resistant infections. Our most advanced product, DAV132, is designed as a prophylactic treatment intended to prevent the development of
C. difficile infection, by binding with and neutralizing common antibiotics in the gut
.
DAV132 decreases the risk of triggering CDI by inactivating residual antibiotics in the colon
before they can disrupt the bacterial flora, without impacting the systemic efficacy of the antibiotics.

It is noteworthy that DAV132 is developed to accompany all oral and intravenous antibiotics of any class and would therefore significantly reduce the risks to acquire C.difficile infections for patients at risk (especially patients who had prior episodes). We see DAV132 as a real game changer for C.difficile prevention.

Have a look at our video presenting the mechanism of action of DAV132:

http://davolterra.com/content/dav132-preventing-occurence-and-recurrence-clostridium-difficile-infections-video

The video is highly illustrative of what C.diff is and how C.diff is triggered.

We have already performed 2 clinical trials with DAV132 and we have a very exciting dataset (both preclinical and clinical) suggesting that DAV132 will very effectively prevent C.diff infections. I would be happy to exchange with you more information on this. Our next clinical trial, in patients actually treated with antibiotics and at-risk of C.diff, will start in Q4 2015 or early 2016.

————————————————————–

Valneva Announces Start of Phase II Clinical Trial of its Clostridium difficile vaccine candidate

  • First Study participant(s) enrolled in Phase II trial which aims to enable Phase III entry upon successful completion
  • Study to enroll 500 healthy subjects aged 50 years and older in the United States and Germany
  • First results are expected in Q4 2015

   Lyon (France), December 18, 2014European biotechnology company Valneva SE (“Valneva”) announced today the initiation of the Phase II clinical trial of its VLA84 prophylactic vaccine candidate against Clostridium difficile (C. difficile), the main cause of nosocomial diarrhea. Data from the Phase I study in healthy elderly and adults showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies, supporting the Company`s decision to progress the vaccine
candidate into Phase II

…………………………………………………………………..

C. diff. Infection (CDI) Treatments On the Horizon

Seres Therapeutics is a clinical-stage therapeutics company focused on discovering and developing drugs to treat diseases of the microbiome. The biology of the microbiome is driven by ecologies—the functional collections of various organisms—which are central to health and disease. Seres is developing Ecobiotic® therapeutics to treat diseases where an abnormal (unhealthy) microbiome is a significant factor in the underlying cause of the disease. Our first clinical program, The ECOSPOR Research study is in the treatment of recurrent
Clostridium difficile infection.
About The ECOSPOR Research Study  Although antibiotics are used to treat recurrent
C. difficile infection, most of the time they do not cure C. difficile. In addition, antibiotics continue to wipe out the good bacteria that protect you
against C. difficile. Currently, there are no medications available that can prevent this infection from coming back when your gut is defenseless.

SER-109 is an investigational medicine being developed to prevent recurrent C. difficile from coming back again. The idea is to first treat patients with antibiotics that work against C. difficile so that the diarrhea goes away. Then patients may get SER-109 to keep the C. difficile infection from coming back.

In the ECOSPOR study, doctors will compare SER-109 to a placebo pill, which looks like SER-109. However, the placebo pill will have no medication inside it. Patients will be randomly assigned to receive either SER-109 or placebo. The study is designed to provide more information about the potential safety and effectiveness of SER-109, and will last about 7 months. The results will help doctors and researchers learn whether SER-109 could one day be used to prevent recurrent CDI.

Who Is Eligible For The ECOSPOR Study?
To pre-qualify for this study, a person must:
• Be 18 years of age or older
• Have a history of at least 3 episodes of Clostridium difficile Infection (CDI) in the last 9 months, including the current episode
• Not have active irritable bowel syndrome with diarrhea within the previous 24 months
All study-related visits, tests, and medication will be provided to the study patients at no cost. In addition, reimbursement for time and travel may be provided.

How to Enroll in the study?   The ECOSPOR Study is now open for enrollment. It is posted on ClinicalTrials.gov.All the sites which are enrolling patients are listed on clinicaltrials.gov, including contact information for the sites. If a doctor in the study thinks you may be a good candidate, you will be given complete information about the study including everything you should know before you join.  You can also contact clinicalstudies@sereshealth.com to find a doctor near you who is involved in the study.

To LISTEN to Dr. Shelley Trucksis, Ph.D., M.D., and Dr. David Cook, Ph.D. discuss “Ecobiotics- A Novel Approach to Recurrent C. difficile infections”  Click on the Seres Therapeutics Logo below:

seres-therapeutics-inc-logo

Seres Therapeutics, a leading microbiome therapeutics company, which recently published in the Journal of Infectious Diseases, positive results from an open-label Phase 1b/2 study of SER-109 for the treatment of patients with recurrent C. difficile infections (CDI). Seres Therapeutics is creating a new class of medicines to treat diseases resulting from functional deficiencies in the microbiome, a condition known as dysbiosis. New insights into the human microbiome are fundamentally reshaping how we understand and treat a wide range of diseases, creating new possibilities for patients not served by current therapeutic approaches. Ecobiotics are ecological compositions of beneficial organisms that are designed to reestablish a healthy microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases. 2016

…………………………………………………………………………………………………………………………………

summit

Summit Therapeutics  has reported ‘outstanding’ results in the phase II trial of ridinilazole, its new C.difficile infection (CDI) treatment.

During the trial, the new oral antibiotic significantly outperformed vancomycin, the current standard prescription, which was the primary objective said Summit.

Over two-thirds (66.7%) of those treated showed a sustained clinical response (SCR) against 42.4% for vancomycin.

The statistical superiority was driven by a large numerical reduction in recurrent disease compared with vancomycin, which Summit said was key as recurrence is one of the hardest things to stop.

C.difficile or CDI is a growing danger for patients in hospital, care homes and the wider community.

Annually, there are between 450,000 and 700,000 cases in the US alone, with the elderly and sick especially vulnerable.

One study has suggested it costs US $4.8bn to treat these people.

“The healthcare community is acutely aware of the major threat CDI poses, particularly given widespread antibiotic use and our aging population,” said Glyn Edwards, Summit’s chief executive.

The biggest unmet need in CDI treatment is reduce recurring cases, he added and the results from the latest trial had exceeded its ‘wildest expectations’.

“These outstanding clinical data from CoDIFy strongly support the profile of ridinilazole as a narrow spectrum antibiotic.

“There is a vital need for potent new antibiotics, and the potential of ridinilazole has attracted great interest.

Edwards added that the results from the CoDIFy trial were exceptionally encouraging and the aim no is to advance ridinilazole into Phase 3 clinical trials.

Here, the company would evaluate partnership opportunities against the benefit of it forward itself, he added.

Professor Mark Wilcox, at Leeds University and Public Health England’s lead consultant on C.difficile added that the latest data indicated ridinilazole could become an important new treatment option for CDI with the potential to reduce the high rates of recurrent disease that remain a key clinical challenge.

CoDIFy was a double blind, randomised, active controlled, multicentre, Phase II clinical trial that evaluated the efficacy of ridinilazole against vancomycin in 100 patients in the US and Canada.

Results from a second CoFIFy trail are due next year, though Edwards said the results announced today would provide the bulk of the quantitative data.

ridinilazole has already received Qualified Infectious Disease Product, or QIDP, designation and has been granted Fast Track status from the US Food and Drug Administration

……………………………………………………………………………………………………….

rebiotixlogo

Rebiotix Inc. is a clinical stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. Microbiota Restoration Therapy (MRT) is the company’s platform for delivering live microbes into a sick patient’s intestinal tract to treat disease.

Clinical Program
PUNCH™ CD is the name of Rebiotix’s clinical program to assess the safety and efficacy of RBX2660 for the treatment of recurrent Clostridium difficile (C. diff.) infection. It is the most advanced human clinical program evaluating a microbiota-based drug conducted in coordination with the U.S. Food and Drug Administration (FDA) with the goal of developing and commercializing a new therapy to treat patients with recurrent episodes of C. diff. infection. Rebiotix has completed enrollment its PUNCH CD 2 study and continues to assess the safety and efficacy of RBX2660.

PUNCH™ CD 2
Rebiotix has completed enrollment in its PUNCH CD 2 study, a Phase 2B multi-center, randomized, double-blind, placebo-controlled trial to evaluate RBX2660 for the treatment of recurrent C. diff. infection. A total of 117 patients recruited at more than 20 sites in the U.S. and Canada were enrolled in the study, which is the largest randomized controlled study of a MRT for recurrent C. diff. to date.

In this study, the patients received either the microbiota-based drug or a placebo via enema. Neither the doctor nor the patients knew what treatment was received in order to get an unbiased measurement of the drug’s true effectiveness. If a patient’s C. diff. infection symptoms returned, even if they were in the placebo arm of the study, they may have been eligible to receive RBX2660. This is referred to as the open-label portion of the study.

PUNCH™ CD
The PUNCH CD study, which was a Phase 2 open label safety and preliminary efficacy study of RBX2660, was successfully completed in July 2014. An open label study means everyone enrolled in the study got the treatment and it is generally the first phase of a new product development program. The study demonstrated a success rate of 87% for those treated with no serious adverse events related to either the product or the method of delivery.

Product Pipeline
Rebiotix is currently exploring the feasibility of an oral formulation, RBX7455, for the prevention of C. diff.

In addition, Rebiotix is leveraging their years of knowledge and experience to develop MRT applications for other conditions that result from disruption of the gut microbiota.

For more information on Rebiotix and the PUNCH CD and PUNCH CD 2 studies go to:
http://www.rebiotix.com or clinicaltrials.gov.

Caution: Drug products are in development and investigational at this time. No product has yet been approved by the U.S. Food and Drug Administration.

……………………………………………………………………………………………………………………………………

MERCKBW2015_medLogoBLK [Converted] (2)

Merck & Co. will file the first antibacterial monoclonal antibody by the end of 2015, the company says.

bezlotoxumab was successful in two Phase III trials against the recurrence of

Clostridium difficile (C. difficile) infection when combined with antibiotics.

Merck plans to file new drug applications for the monoclonal antibody in the US, Canada and EU by the end of the year. Currently, there are no therapies approved for the prevention of recurrent disease caused by C. difficile.

Bezlotoxumab’s approval would also make it the first antibody to treat bacterial infection.

Scientists say mAbs would have benefits over small molecule antibiotics because they are less likely to drive antimicrobial resistance and are administered less frequently. “Results of these studies showed that a single, one-time infusion of the antitoxin bezlotoxumab given with standard of care C. difficile antibiotic treatment significantly reduced the recurrence of C. difficile infection compared to standard of care alone, and demonstrated this benefit over a 12-week period,” said lead investigator Mark Wilcox of the University of Leeds, UK. “These results were also demonstrated in patient subgroups known to be at high risk for C. difficile recurrence.”

C. difficile toxin B can damage the gut wall and cause inflammation, leading to the symptoms of C. difficile enteritis, which include abdominal pain and watery diarrhea. Bezlotoxumab, a fully-human monoclonal antibody, was developed by researchers at the University of Massachusetts Medical School’s MassBiologics Laboratory with Medarex (now part of Bristol-Myers Squibb), and licensed to Merck in 2009.

The studies   Merck’s studies took more than 1,000 patients each and evaluated them over 12 weeks. Participants received either a single infusion of bezlotoxumab, actoxumab (another mAb designed to fight C. difficile),a combination of the two, or a placebo. The actoxumab arm of the study ended early for efficacy and safety reasons.    Both studies had infection recurrence as their primary endpoint – this rate was significantly lower for the bezlotoxumab arms (17.4% and 15.7%) and bezlotoxumab plus actoxumab arms (15.9% and 14.9%), compared to placebos (27.6% and 25.7%). Actoxumab was found not to provide extra benefit on its own or combined with bezlotoxumab, so Merck’s marketing authorisation application is for bezlotoxumab alone.

MERCK2015_Logo_3282_2f432 (2)

To Listen to the Podcast — MERCK’s Dr. Nicholas Kartsonis discusses the many contributions of Merck and ongoing research addressing CDI  — and  the history in addressing infectious disease and antimicrobial resistance. Dr. Nick Kartsonis also  discusses the future in the area of C. diff. and some of the company’s current treatments, including DIFICID and their ongoing research addressing CDI  Click on the MERCK Logo Above *

………………………………………………………………………………………………………………………………………

DIFICID (fidaxomicin) is currently FDA approved to treat Clostridium difficile-associated diarrhea (CDAD) in adult patients 18 years of age and older.

Currently, clinical trials are ongoing to assess the efficacy and safety of DIFICID, in either a tablet and oral suspension formulation, in pediatric patients with CDAD.  **  In addition, DIFICID is currently in clinical trials to determine the efficacy of use as a prophylaxis against CDAD in adult patients undergoing hematopoietic stem cell transplantation (HSCT).

…………………………………………………………………………………………………………………………………….

XBiotech is a biotech company located in Austin, Texas and was founded on the concept of the “True Human Antibody”.  Antibodies are specialized proteins, which are produced by the immune system.  Their function is to bind to a very specific target, such as a virus or bacteria, and aid in the elimination of these targets by the immune system.  Monoclonal antibodies were developed as a class of drug, which use the specific targeting function of the antibody to target substances that cause disease. Currently approved monoclonal antibodies however, are developed in the laboratory or in mice.  XBiotech’s approach is to isolate antibodies that are present naturally in healthy human donors, and develop these into products that can be used to treat disease.  We believe that antibodies isolated from humans, will be safer and will function better than so called antibodies marketed as “fully human”, which are in fact engineered.

Over the past decade, Clostridium difficile (C. diff) has emerged as a significant public health threat.  In fact, the CDC has designated it as an “Urgent threat level.”

In October 2015, XBiotech announced it had set out to develop a first-in-class oral monoclonal antibody against C. diff infection. Just two weeks after this announcement, the Company reported it had already identified positive blood samples for anti-clostridium difficile antibodies after screening blood donations from healthy volunteers.

XBiotech’s plans to develop an antibody therapy that directly targets and neutralizes the bacteria. The Company intends to deliver the therapy orally, targeting C. diff in the gastrointestinal tract, where the antibody could reduce the bacteria’s ability to establish debilitating or life threatening infections.

XBiotech

Click on the XBiotech LOGO to the left  to listen to the February 2016  XBiotech Podcast which introduces XBiotech, developer of True Human(TM) therapeutic antibodies. XBiotech has an exciting pipeline of product candidates in various areas of medicine. The Company recently announced the launch of a research and development program to develop a first-in-class oral monoclonal antibody against Clostridium difficile (C.difficile) infection. The Company will discuss the need for an effective C.difficile therapy, their novel approach to treating the disease as well as efficiency in their manufacturing technology. Join guests: Dr. Michael Stecher, Medical Director, Dr. Sushma Shivaswamy, Vice President of Research and Development, and Kelly Thornburg, Senior Vice President of Operations, as they discuss how XBiotech is pioneering a new era in the discovery and development of targeted antibodies therapeutics.

For more information please contact the Company by emailing info@xbiotech.com or calling 512-386-2900.    www.xbiotech.com