Tag Archives: Protecting the Gut Microbiome

Da Volterra Shared Results From Phase I Clinical Trial of DAV132 to Prevent Gut Microbiome Disruption Caused by Antibiotics and Prevent C. diff. Infections

DAV132 is a first-in-class product to protect the microbiome during antibiotic treatments and prevent Clostridium difficile infections.

French biotech Da Volterra is developing products to fight the rapidly rising rates of antibiotic resistance. During a Phase I study, the company’s medical device, DAV132, was used with the antibiotic, moxifloxacin, and successfully protected the intestinal microbiota from antibiotic residues. Overall, the product managed to reduce exposure of the microbiota to the antibiotic by 99% and maintain 97.8% of the microbiome’s genetic richness without affecting the drugs therapeutic efficacy.

In a randomized, controlled clinical trial performed in 44 healthy human volunteers, DAV132 was used in association with moxifloxacin, a widely used fluoroquinolone antibiotic. It was demonstrated that DAV132 is able to effectively capture residual antibiotics in the colon and reduce their concentration to very low levels. DAV132 reduced exposure of the intestinal microbiota to moxifloxacin by 99%. Meanwhile the plasma concentration of the antibiotic was essentially unaffected by the co-administration DAV132, meaning that its therapeutic efficacy will be maintained.

The ability of DAV132 to protect the intestinal microbiome was explored by identifying changes in bacterial gene richness as well as a detailed statistical analysis of the evolution of bacterial species throughout the study. In volunteers who received moxifloxacin alone, gene richness was drastically diminished to 54.6% of baseline after antibiotic treatment and failed to return to baseline even one month after treatment; 39% of bacterial species identified in the intestinal microbiota were affected. The co-administration of DAV132 with moxifloxacin largely protected the intestinal microbiome from disruption (97.8% of baseline for bacterial gene richness, and 93% of bacterial species protected).

The primary endpoints for the study were fully achieved and DAV132 showed an excellent tolerability profile.

Annie Ducher MD, Chief Medical Officer of Da Volterra, declared: “This clinical study is indicative of the potential of DAV132 to become one of the first preventative solutions to protect the intestinal microbiome and further avoid the detrimental consequences of antibiotic treatments, such as Clostridium difficile infections, for patients. We look forward to advancing the development of DAV132 in a pivotal patient study in 2018.”

Jean de Gunzburg PhD, Chief Scientific Officer of Da Volterra, added: “This study constitutes the first scientific demonstration of the protection of the intestinal microbiome from dysbiosis caused by a fluoroquinolone antibiotic treatment; our data suggests that this effect should be extendable to many different antibiotics from several therapeutic classes. The metagenomics analysis is outstanding and thoroughly convincing that DAV132 is highly effective at protecting the commensal bacteria in the intestines.”

The results are available under the reference: Gunzburg et al. Protection of the human gut microbiome from antibiotics. The Journal of Infectious Diseases, jix604, https://doi.org/10.1093/infdis/jix604.

***

About DAV132:
With a novel and unique mechanism of action, DAV132 is a product candidate aiming to protect the intestinal microbiome from the side effects of antibiotics, hence preventing the onset of C. difficile infections. DAV132 is an adsorbent with a proprietary coating with colon targeted delivery. DAV132 has been tested in four Phase 1 clinical studies with no adverse safety events. DAV132 is currently entering a Phase 2 clinical trial.

About Da Volterra:
Da Volterra is a biopharmaceutical company based in France that develops new strategies aimed at protecting the intestinal microbiome from the deleterious effects of antibiotics, and preventing multi-resistant and life-threatening infections. Da Volterra’s innovative approaches promise a substantial medical progress to combat deadly pathogens. http://www.davolterra.com

(January 2018)

To read the article in its entirety, please click on the following link to be redirected:

https://www.businesswire.com/news/home/20180116005398/en/Da-Volterra-Announces-Publication-Full-Results-Clinical

Centers for Disease Control and Prevention (CDC) Awards Research Contract To Synthetic Biologics For Microbiome Assessment and Approaches To Better Combat Antibiotic Resistance

Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)

“To protect people, their microbiomes, and the effectiveness of antibiotics, this project is an example of applied research that has the potential to produce innovative public health approaches to better combat antibiotic resistance.”

Synthetic Biologics, Inc.  a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases, announced today it has been awarded a contract by the Centers for Disease Control and Prevention (CDC).

The award will support research conducted during the Company’s ongoing randomized, placebo-controlled Phase 2b proof-of-concept clinical study of SYN-004 (ribaxamase), designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms.

“Antibiotics are life-saving medicines, but they also can disrupt a person’s microbiome and increase the risk for drug-resistant infections,” said Dr. Clifford McDonald, Associate Director of Science for CDC’s Division of Healthcare Quality Promotion. “To protect people, their microbiomes, and the effectiveness of antibiotics, this project is an example of applied research that has the potential to produce innovative public health approaches to better combat antibiotic resistance.”

The contract, awarded through the CDC’s Advanced and Innovative Solutions to Improve Public Health Broad Agency Announcement (BAA) 2016-N-17812, will support CDC’s efforts to assess how selective pressure from IV antibiotics may lead to the emergence of antibiotic resistance in the gut microbiome. The funding will also support research to evaluate ribaxamase’s ability to reduce selective pressure associated with the emergence of antibiotic-resistant organisms in the gut microbiomes of patients enrolled in the Company’s ongoing Phase 2b clinical trial. The Company will examine DNA isolated from longitudinal samples obtained during the clinical trial and look for changes to the patient’s gut resistome, specifically examining for alterations in the presence and/or abundance of antibiotic resistance genes.

“Synthetic Biologics is proud to have the support of the U.S. Government in its efforts to study the role of antibiotics in mediating resistance in the gut microbiome,” said Jeffrey Riley, President and Chief Executive Officer. “Ribaxamase’s strategy of degrading certain IV beta-lactam antibiotics before they are excreted into the GI tract has the potential to protect the gut microbiome from disruption by these antibiotics without inhibiting their ability to fight primary infections as well as mitigate conditions conducive to antibiotic-resistance development. We look forward to our collaboration with CDC and to furthering their initiative to assess and address rising global concerns for the proliferation of antibiotic resistance.”

 

To read the article in its entirety click on the following link:

http://ir.syntheticbiologics.com/press-releases/detail/221

 

C. difficile Infection (CDI) Prevention, Treatment, Environmental Safety, Research, Clinical Trials Being Discussed with World Topic Experts On September 20th In Atlanta, Georgia USA

Cdiff2015BallroomPic

September 20th

It is with great pride and certainty in the power of the healthcare community to present the 4th Annual International Raising. C. diff. Awareness Conference and Health Expo

being hosted at the

DoubleTree by Hilton — Atlanta Airport 
3400 Norman Berry Drive
Atlanta,Georgia 30344 USA  (Hotel Phone: 1-404-763-1600)

Doors open at 7:15 a.m — Sign In and Continental Breakfast

Conference begins at: 7:30 a.m. – 5:00 p.m.

TAtlantaPic

Raising C. difficile awareness is essential to build upon and advance existing knowledge and necessary for overcoming the challenges our healthcare communities are faced with today.

“None of us can do this alone — All of us can do this together”

Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released February 25, 2015 by the Centers for Disease Control and Prevention (CDC).   C. diff. is a leading cause of infectious disease death worldwide; 29,000 died within 30 days of the initial diagnosis in the USA.   Previous studies indicate that C. diff. has become the most common microbial cause of healthcare-associated infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone.

###

Cdiff2015-1Clinical professionals gather for one day to present up-to-date data to expand on the existing knowledge and raise awareness of the urgency focused on a Clostridium difficile infection (CDI) —

    • Prevention
    • Treatments
    • Research
    • Environmental Safety
    • Clinical trials and studies

WITH

  • Microbiome research, studies
  • Infection Prevention
  • Fecal Microbiota Restoration and Transplants for Adults & Pediatrics
  • A Panel Of C. diff. Infection Survivors
  • Antibiotic Stewardship
  • Healthcare EXPO
    ……………………and much more.

You won’t want to miss out on this opportunity to learn from
International topic experts delivering data directed at evidence-based
prevention, treatments, and environmental safety in the C. diff.
and healthcare community.

Gain insights on September 20th that will not be available anywhere else with an opportunity to receive up-to-date data on major topics in this program being presented in one day.

5 Leading reasons to attend this dynamic conference:

  • Learn from leading healthcare professionals, clinicians, researchers, and industry.
  • Networking opportunities with new and reconnect with those in the healthcare community with similar interests.
  • Gain breakthrough results through research in progress and gaining positive results. Programs focused on Antibiotic-resistance such as the  Antibiotic Stewardship making a difference. Front line developments in progress focused on C. diff. infection prevention, treatments, environmental safety.
  • Implement and share the knowledge well after the conference ends.  Every attendee receives a booklet with guest speakers information, media to review audio programs, and Health Expo Sponsor information focused on the important agenda topics.
  • Embrace the opportunity, with all of the topic experts presenting, and hold the conference in the highest priority from the participation in this conference to an audience of medical students, and fellow healthcare professionals, who will benefit the most from the data and gain tools to overcome the barriers facing healthcare each day.

“The information and up-to-date studies shared at the 2015 conference added to an existing knowledge base that helps us to continue delivering quality care in the medical community.”   Linda Davis, RN,BSN

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

REGISTRATION FEES:

$75.00  —  Conference Registration

$30.00  —  Student Conference Registration (Student ID To Be Presented At the Door)

TO REGISTER Click on the “Raising C. diff. Awareness” Ribbon below

CDiffAwarenessRibbon2015

Room accommodations are available —  Complete and Confirm 

by August 19th to reserve your hotel reservations.   

To create a reservation please click on the DoubleTree By Hilton Logo below – – – – – –

DoubleTreeLogo

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

 A suggested travel coordinator, for your convenience

LibertyTraveldownloadMichael Beckman — Team Leader,  Liberty Travel, 467 Washington Street, Boston, MA  02111
617-936-2435
Michael.Beckman@flightcenter.com

 For Additional Information visit the C Diff Foundation Website:

https://cdifffoundation.org/

https://cdifffoundation.org/

And Click on the 2016 September Conference Tab

 

Follow us on Twitter
@cdiffFoundation
#Cdiff2016

European Patent Office Has Granted European Patent Which Provides Composition Of Matter Coverage For Synthetic Biologics’ ribaxamase

SyntheticBiologics2016LOGO

Synthetic Biologics; a clinical stage company focused on developing therapeutics to protect the gut microbiome announced on July 12, 2016  that the European Patent Office has granted European Patent No. 2576776 which provides composition of matter coverage for ribaxamase, the Company’s Phase 2 drug candidate designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of Clostridium difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms.

This is Synthetic Biologics’ first patent directly pertaining to ribaxamase in Europe and adds to the Company’s established and extensive patent estate.

In addition, the U.S. Patent and Trademark Office (USPTO) has granted
US Patent No. 9,376,673, and issued a Notice of Allowance for another application (US 15/160,669), with composition of matter claims for various beta-lactamase candidates related to ribaxamase. These new patent assets further strengthen the Company’s coverage of its novel proprietary candidate, ribaxamase, which is also covered by a previously granted composition of matter patent in the U.S.

“The successful granting of this composition of matter patent in Europe, alongside our continued patent successes in the U.S., further strengthens Synthetic Biologics’ role as a leader in the development of microbiome-focused programs intended to address largely unmet medical needs,” said Jeffrey Riley, President and Chief Executive Officer. “As we continue to enjoy momentum in the clinic, our progress is further complimented by our well established and reinforced patent estate for ribaxamase.”

Ribaxamase is designed to degrade certain intravenous (IV) beta-lactam antibiotics excreted into the gastrointestinal (GI) tract to maintain the natural balance of the
gut microbiome.

C. difficile is associated with approximately 453,000 CDIs and > 29,000 C. difficile-related deaths in the United States each year[i].

Upon issuance, these newly allowed applications reinforce Synthetic Biologics’ extensive C. difficile-related patent estate, which includes approximately 40 U.S. and foreign patents and approximately 30 U.S. and foreign patent pending applications, and patents and patent applications with terms that extend from at least 2031 to 2036.

 

To read this article in its entirety click on the link below:

http://ir.syntheticbiologics.com/press-releases/detail/216

PODCAST of June 28th C. diff. Spores and More With Guests Dr. Sliman & Dr. Pimentel As We Discuss Synthetic Biologics: Protecting the Gut Microbiome and Maintaining Human Health

 

Listen to the PODCAST of the live broadcasted

on  June 28th,  2016

cdiffRadioLogoMarch2015CLICK ON THE LOGO TO BE REDIRECTED TO THE PODCAST OF THE LIVE BROADCAST

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


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

This Episode:  

Synthetic Biologics: Protecting the Gut Microbiome
and Maintaining Human Health

With Our Guests:

Dr. Joseph Sliman, MD
Senior Vice President, Clinical & Regulatory Affairs

Dr. Mark Pimentel, MD, FRCP(C)
Director of the GI Motility Program and Laboratory at Cedars-Sanai

On Tuesday, June 28th  we discussed public awareness of the microbiome and its link to human health – is on the rise as evidenced by recent government-sponsored programs such as the National Microbiome Initiative.  Protection of the natural gut microbiome from the unintended consequences of intravenous (IV) antibiotics, which are excreted into the gut, is expected to protect against opportunistic enteric infections.   Recent clinical data suggest that the absence or abundance of certain microbes may be directly linked to certain infections and diseases including a Clostridium difficile infection (CDI), and irritable bowel syndrome (IBS).   Synthetic Biologics is developing two microbiome-focused drug candidates in Phase 2 development including SYN-004 which is designed to protect the gut microbiome by degrading certain IV beta-lactam antibiotics for the prevention of a CDI, antibiotic associated-diarrhea (AAD) and the emergence of antibiotic-resistant organisms.  And SYN-010 is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).   Synthetic Biologics Inc.’s Joseph Sliman, MD, Senior Vice President, Clinical and Regulatory Affairs with Mark Pimentel, MD, FRCP(C), Director of the GI Motility Program and Laboratory at Cedars-Sinai, will be discussing both the Company’s novel microbiome-focused product candidates.

 

MORE ABOUT OUR GUESTS:

Dr Joseph Sliman, MD, Senior Vice President, Clinical and Regulatory Affairs.

Dr. Sliman joined Synthetic Biologics in January 2013 as the Senior Vice President, Clinical & Regulatory Affairs. In this position, Dr. Sliman will be responsible for the design and implementation of all aspects of clinical development, including clinical trials, and will lead the Company’s regulatory initiatives. During his service in the United States Navy, Dr. Sliman led the U. S. Pacific Fleet disease surveillance programs, including influenza surveillance, preparedness, and prevention, as well as communicable disease and injury surveillance and prevention and health policy development. Dr. Sliman earned an M.D. from the Uniformed Services University, a Master’s Degree in Public Health from the Johns Hopkins University School of Public Health, and a B.S. in Molecular and Cell Biology, with Honors in Biology, from Pennsylvania State University

Dr Mark Pimental, MD, FRCP(C), Director of the GI Motility Program and
Laboratory at Cedars-Sanai.

Mark Pimentel, MD, FRCP(C), is Director of the GI Motility Program and
Laboratory at Cedars-Sinai, Associate Professor of Medicine at CSMC and Professor of Medicine at UCLA Geffen School of Medicine in Los Angeles, CA. Dr. Pimentel completed three years of undergraduate degree with honors in microbiology and biochemistry at the University of Manitoba, Canada. This was followed by his medical degree and his BSc(Med) from the Univeristy of Manitoba Health Sciences Center in Winnipeg, Manitoba, Canada where he also completed a residency in internal medicine. His medical training includes a fellowship in gastroenterology at the UCLA Affiliated Training Program. Active in research Dr. Pimentel has served as a principal investigator or co-investigator for numerous basic sciences, transitional, and clinical studies in such areas as IBS, and the relationship between gut flora composition and human disease.

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

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

Synthetic Biologics Announced Positive Topline Results From the Second Phase 2a Open-Label Clinical Trial of SYN-004, Prevention of C.diff. Infection (CDI) and Antibiotic-associated Diarrhea (AAD)

SYN-004 Degraded IV Ceftriaxone in the Presence of a Proton Pump Inhibitor in the Gastrointestinal Tract without Affecting Antibiotic Levels in the Bloodstream —

— Two Poster Presentations Planned for ASM Microbe 2016, Including Detailed Data from Two SYN-004 Phase 2a Open-Label Clinical Trials —

SyntheticBiologics2016LOGO

Synthetic Biologics, Inc. a clinical stage company focused on developing therapeutics to protect the gut microbiome, announced positive topline results from the second Phase 2a open-label clinical trial of SYN-004, the Company’s candidate designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. Results from 14 participants who completed this clinical trial were analyzed to assess the ability of the 150 mg dose of SYN-004 to degrade ceftriaxone when administered alone and with the proton pump inhibitor (PPI), esomeprazole.

 

To read article in its entirety:

http://ir.syntheticbiologics.com/press-releases/detail/211

 

 

 

Synthetic Biologics To Participate At the 2016 RBC Capital Markets Global Healthcare Conference

2016 RBC Capital Markets Global Healthcare Conference on Tuesday, February 23, 2016
at 4:35 p.m. (ET) in the Holmes II room at the New York Palace Hotel in New York.

Synthetic Biologics, a clinical stage company focused on developing therapeutics to protect the gut microbiome, announced that Jeffrey Riley, President & Chief Executive Officer, is scheduled to participate in an analyst-led fireside chat with the Company’s covering analyst, Adnan Butt at the 2016 RBC Capital Markets Global Healthcare Conference.

A live webcast of Synthetic Biologics’ fireside chat may be accessed by logging onto the internet at https://www.veracast.com/webcasts/rbc/healthcare2016/17116241334.cfm.

After the discussion, a replay will be archived and accessible for 90 days at the same website.

SyntheticBiologics2016LOGO

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company’s lead candidates in Phase 2 development include:

(1) SYN-004 which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD),

and

(2) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). In collaboration with Intrexon Corporation (NYSE: XON), the Company is developing a preclinical stage monoclonal antibody for the prevention and treatment of Pertussis, and discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com                                                 

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/synthetic-biologics-to-participate-in-fireside-chat-at-rbc-capital-markets-global-healthcare-conference-300220874.html

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.