Category Archives: Clinical Trials

Patient, Family, Caregiver January Symposium Broadcasts During March On C. diff. Spores and More Live Program

CDIFFRADIO.COM

 

 

 

 

 

 

 

SAVE THE DATES to listen in to the leading topic expert presentations

shared on January 15, 2021, at the Patient, Family, Caregiver Symposium:

Beginning Tuesday, March 9 from 1:00 p.m. – 2:00 p.m. EST following through on

March 16,  March 23, and  March 30.

A Symposium specifically developed for Patients Diagnosed With a C. diff. Infection, Being Treated For a Clostridioides diffiicile infection, Recovering From a Clostridioides difficile Infection and Recurrences with Family Members and Caregivers.

The Patient & Family C. diff. Symposium was a gathering of healthcare professionals, keynote speakers, health advocates, practitioners, educators, thought leaders, and patients who are transforming the patient experience and changing the way people experience
C. diff. infections worldwide.

Unlike other conferences on this topic, patients will share their C. diff. infection journeys, providing a real-world perspective on patient experience. Our attendees will learn more from this virtual-online symposium and gain knowledge on important topics that will better aid their care and recovery through tools and strategies delivered by keynote speakers.  

The Symposium followed the C Diff Foundation Mission statement –   Educating and Advocating for the prevention, treatments, clinical trials, diagnostics, and environmental safety of Clostridioides difficile
(C. diff.) infections worldwide.

Keynote speakers presented up-to-date data to expand on the existing knowledge and provide important information focused on, yet not limited to,  a Clostridioides difficile infection (also known as C. diff., C. difficile, CDAD, CDI) ……

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

WITH

  • Introduction to Microbiome Research and Studies
  • Infection Prevention
  • Fecal Microbiota Restoration and Transplants
  • Antibiotic Stewardship

We hope you enjoy the broadcasts!

 

Program Chair:  Paul Feuerstadt, MD, FACG

Barbara McGovern, MD     “Treatment of recurrent C. difficile infection with                                                                                        SER-109, an investigational microbiome drug.”

Paul Feuerstadt, MD          ” C. diff. Overview – What is a C. diff. Infection?”

Sahil Khanna, MD               “C. diff. Treatments + FMT Overview. “

 

 

 

Simon Cutting, Ph. D.         “Bacillus, and C. diff.  Spore Overview. “

Teena Chopra, MD                ” Introduction to Infection Prevention.”

Doe Kley, RN, MPH              “C. diff. Transitioning from Hospital to Home. “

Courtney Jones                    ” Microbiome, Microbiota, and Gut Health.”

Denise Cardo, MD                “Everyone Has a Role in Antibiotic Awareness.”

Larry Kociolek, MD              “C. diff. Infections in Pediatrics.”

Kathy Bischoff                        “My C. diff.  Journey.”

Renata Johnson                      “My C. diff. Journey.”

Paul Feuerstadt, MD      &    Barbara McGovern, MD

 

This Symposium was hosted by the C Diff Foundation and

Sponsored by Seres Therapeutics  

Please — Do Not Take Medicine Into Your Own Hands, You Are NOT Out Of Options

Do-It-Yourself Treatments Could Be Fatal……

You are NOT out of options………………………

During these unprecedented times, we understand the patient’s frustration and how this pandemic has created a halt to the readily accessible alternative treatment option in the FMT community.   The need for continued treatments for a C. diff. infection and recurrent C. diff. infections are real and necessary. We also understand how patients experiencing
recurrent C. difficile infections are desperately seeking the FMT alternative treatment.

C Diff Foundation is able to provide information about treatments available to safely treat  CDI’s and recurrent C. diff. infections.

Most home remedies or natural therapies, though, haven’t been put through the same rigorous clinical testing you expect from pharmaceutical medications.

In a world where you can fix almost anything with a do-it-yourself video on YouTube, you might think curing your own illness would be a piece of cake. It might be if it weren’t for a couple of (not so small) sticking points.  One, the home remedy recommended by your friend — or one of the many websites promoting “natural therapies” — might not work.1  Dr. Harriet Hall, a retired family physician, former Air Force flight surgeon, and author of the SkepDoc column in Skeptic magazine, is one of those leading the charge against medical “treatments” not supported by science.  Like others in the medical and scientific community, ……. There is the only medicine that has been tested and proven to work, and medicine that hasn’t,” Hall told Healthline. 1

Talk to your medical professional/s.

Discuss medications and clinical trials available.

Do Not Share Antibiotics.

Responses to an anonymous online questionnaire of 496 parents, researchers at the Cohen Children’s Medical Center of New York reported that 48 percent of the parents surveyed said they’ve held onto leftover antibiotics. More troubling to researchers was that of those parents, 73 percent reported giving those antibiotics to siblings, unrelated children, and unrelated adults.  This would sometimes occur months after the drugs were originally prescribed.
Dr. Ruth Milanaik, director of the neonatal neurodevelopment follow-up program at Cohen and senior author of the study, says the results show an “alarming” percentage of parents engaging in sharing or borrowing antibiotics, a practice known as prescription diversion.  “This is dangerous not only for those given antibiotics that weren’t prescribed for them but for entire populations of people who some antibiotics may no longer help when the bacteria they target become resistant to them,” Milanaik said in a statement. 2

Discuss Resources available.

Times are trying during these unprecedented times and you are not without hope – we would like to help you and not see you get hurt or even worse. Please take time to speak to your treating physician and consider contacting a C Diff Foundation Triage Nurse at 727-205-3922 to learn more about safe and effective treatments available and options available to you at this time of desperation.

Remember – You  Are Not Out of Options.

Stay safe – and please – Do NOT take medicine into your own hands.

Thank You!

Resources:
1 Foxnews.com
2 Healthline.com

 

 

Destiny Pharma Update On the Acquired NTCD-M3 Biotherapeutic Clinical Program For Prevention of Recurrence of C. diff. Infections (rCDI)

Update on the recently acquired NTCD-M3 biotherapeutic clinical programme for prevention of recurrence of C. difficile infections

Press release by Destiny Pharma:

Brighton, United Kingdom – 22 December 2020: Destiny Pharma plc (AIM: DEST) a clinical-stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, announces it is making good progress with preparations for the clinical development of NTCD-M3, a Phase 3 ready biotherapeutic for the prevention of C. difficile infection (CDI) recurrence.

Following the successful fundraising of £10.4 million in November 2020 and completion of the acquisition of NTCD-M3, Destiny Pharma has commenced the work required to prepare for the Phase 3 clinical study that is scheduled to start in 2022.

Also, Professor Dale Gerding has joined Destiny Pharma’s Scientific Advisory Board (SAB) and is working as a key consultant. His world-leading expertise in C. difficile infections and many years of research and clinical work on NTCD-M3 will be invaluable and he is an important addition to our team.

Destiny Pharma has also signed a major new contract with a leading biotherapeutics manufacturing company for the establishment of a new NTCD-M3 process for the production of the Phase 3 clinical trial doses. Establishing the new manufacturer will deliver a more efficient process and a lower-cost product and is an important investment in the overall NTCD-M3 project. The Company is also starting business development efforts and will reach out to potential commercial partners and grant funding bodies to raise awareness of the re-activated NTCD-M3 clinical programme.

In the US, there are approximately 500,000 cases of CDI each year; around 25% of these initial cases then recur leading to 29,000 deaths per year. Current CDI treatment options are limited with lower efficacy observed when patients are retreated with the same antibiotic for recurrence of CDI. The extra costs of care in the US per CDI patient range from $10,000 to $20,000 and the total annual CDI-attributable cost in the US alone is estimated in 2016 at $6.3 billion.

Dr. Bill Love, Chief Scientific Officer of Destiny Pharma, said, “We are very pleased to have started activities immediately on our new NTCD-M3 project. Setting up the new manufacturing process is a key step to deliver the doses of NTCD-M3 product required for the single, 800 patient Phase 3 study required by the US FDA. The work will also look at scaling up the process towards commercial supply. We look forward to announcing further progress in 2021.”

Professor Dale Gerding, the discoverer of NTCD-M3, and member of Destiny Pharma’s SAB, added: “I am enthusiastic about the resumption of the final phase of development of NTCD-M3 and welcome the opportunity to work with Destiny Pharma to bring it to patients. As a C. difficile clinician and researcher for nearly 40 years, my mission has been to see this terrible infection prevented. Everything that has been done to date suggests that NTCD-M3 will provide the preventive strategy needed to not only prevent recurrence of C. difficile infection but to also prevent it from ever occurring in the most vulnerable patients.”

Inquiries:

Destiny Pharma plc
Neil Clark (Chief Executive Officer)
Shaun Claydon (Chief Financial Officer and Company Secretary)
+44 (0) 1273 704 440

finnCap Limited – Nominated Adviser and Joint Broker
Geoff Nash / Kate Bannatyne / Charlie Beeson (Corporate Finance)
Alice Lane (ECM)
+44 (0) 20 7220 0500

WG Partners LLP – Joint Broker
Nigel Barnes / Claes Spång / Nigel Birks / Andrew Craig
+44 (0) 20 3705 9330

Optimum Strategic Communications
Mary Clark / Shabnam Bashir / Manel Mateus
+44 (0) 203 174 1789

About NTCD-M3
NTCD-M3 (non-toxigenic C. difficile strain M3) was developed by the US infectious diseases physician, Professor Dale Gerding, who is a world-leading specialist in C. difficile infection, with more than 400 peer-reviewed journal publications, book chapters, and review articles in the area. NTCD-M3 has successfully completed Phase 1 and Phase 2b trials. The Phase 1 study demonstrated a strong safety/toxicology profile and Phase 2b showed that the best dose delivered a 95% prevention of CDI recurrence. The Phase 2b NTCD-M3 data was published in the prestigious Journal of the American Medical Association (Gerding DN et al JAMA
2015;313:1719).

C. difficile NTCD-M3 is a naturally occurring non-toxigenic strain of C. difficile bacteria, which lacks the genes that can express C. difficile toxins. It is an oral formulation of NTCD-M3 spores and patients who have taken NTCD-M3 were found to be protected from recurrence of C. difficile infections. NTCD-M3 acts as a safe “ground cover” preventing toxic strains of C. difficile proliferating in the colon after antibiotic treatment. NTCD-M3 temporarily colonizes the human gut without causing any symptoms allowing the gut microbiome time to recover following antibiotic treatment.

About Destiny Pharma
Destiny Pharma is a clinical-stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital-acquired infection in the US, and also XF-73 nasal gel, which is in a Phase 2b clinical trial targeting the prevention of postsurgical Staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections, and has earlier grant-funded XF research projects.

For further information, please visit https://www.destinypharma.com

Acurx Announces that All Patients Demonstrated Clinical and Sustained Cure in Ph2A Open-Label Trial of Ibezapolstat for the Treatment of a C. difficile Infection

 

 

 

 

– Ibezapolstat is the first of an entirely new class of antibiotics with a novel mechanism of action, a DNA polymerase IIIC inhibitor, to enter clinical efficacy trials

– 10 of 10 patients enrolled in the Ph2A trial met the study’s primary and secondary efficacy 

– No C. difficile was detected in any of the 65 fecal samples tested by Day 3 of treatment and thereafter

– Compelling evidence of efficacy allows early termination of Segment 2A and advancement to Segment 2B

C. difficile bacteria remain on CDC Urgent Threat list, highlighting the need for new CDI treatments

– Ibezapolstat is FDA QIDP and Fast Track Designated for priority review

Acurx Pharmaceuticals, LLC,  a privately held, clinical-stage biopharmaceutical company developing an entirely new class of antibiotics for difficult-to-treat bacterial infections, announced today (November 5, 2020) that all 10 patients (100%) with mild-to-moderate CDI enrolled in this Ph2A open-label clinical trial met the study’s primary and secondary efficacy endpoints following treatment with orally administered ibezapolstat given 450 mg twice daily for 10 days.  FDA has granted Qualified Infectious Disease Product (QIDP) designation and Fast-Track status to ibezapolstat for patients with CDI.

In this Phase 2 clinical trial, Segment 2A was designed to enroll up to 20 patients with a data review planned by a Trial Oversight Committee after 10 patients completed the trial. All 10 patients enrolled in the trial met the study’s primary and secondary efficacy endpoints of Clinical Cure at end of treatment and Sustained Clinical Cure of no recurrence of CDI at the 28-day follow-up visit.  Ibezapolstat was well-tolerated, with no serious adverse events (SAEs) reported in the trial. Based on these successful treatment results, and in consultation with the Company’s medical advisors, the Company has terminated enrollment in Segment 2A early and will advance to Segment 2B.   These results also represent the first-ever clinical validation of DNA polymerase IIIC as a therapeutically relevant antibacterial target.

Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for the microbiome aspects of the trial stated, “Data from my laboratory confirm that ibezapolstat eradicated C. difficile in all fecal samples tested by Day 3 of treatment in this patient population with mild or moderate CDI.  Our ongoing work will characterize the effects of ibezapolstat on the intestinal microbiome in these CDI patients.  A strength of this development program will be the ability to compare the microbiome results in CDI patients to our prior favorable effects relative to vancomycin previously demonstrated in the Phase 1 healthy volunteer trial.”

Stuart Johnson, MD, Professor of Medicine at Loyola University, a CDI expert and an Acurx Scientific Advisory Board (SAB) member, noted, “After reviewing Segment 2A , the SAB is encouraged by the promising results and fully support early termination and advancement to the Ph2B Segment with the next enrolled patient.  The SAB looks forward to successful results from Segment 2B that could pave the way for an important new antibiotic class for the treatment of CDI which remains an area of clear medical need.”

These data will be presented at the 8th Annual International C. diff.  Virtual Conference and Virtual Health Expo on November 14, 2020, https://cdiff2020.com which coincides with the US Centers for Disease Control and Prevention (CDC) declaration of November as Clostridioides difficile Awareness Month.

Robert J. DeLuccia, Co-Founder & Managing Partner of Acurx, stated, “We are very excited by these excellent results allowing early termination of our Phase 2A Segment at 10 patients. We are looking forward to starting our Phase 2B Segment early next year with expectation for completion by the end of next year”.   He further stated, “since ibezapolstat is the first DNA polymerase IIIC inhibitor to advance into clinical trials, this achieves the first human validation of our bacterial target and will enable further development of our pipeline of novel oral and I.V. antibiotics with the same bacterial target and mechanism of action.  Our new compounds are in pre-clinical development to treat other Gram-positive life-threatening infections in skin/skin structure, community-acquired pneumonia, bone & joint, and bacteremia. The spectrum of activity of Acurx’s DNA pol IIIC inhibitors includes pathogens resistant to currently available antibiotics and classified as priority pathogens by the WHO, CDC, and FDA, all of whom emphasize the need for new classes of antibiotics to prepare for the next global infectious disease pandemic, antimicrobial resistance.”

About the Phase 2 Clinical Trial.  In Segment 2A of this trial, 10 subjects with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally for 10 days and evaluated for clinical cure. All cured subjects were followed for a sustained clinical cure at 28 ± 2 days. In Segment 2B, approximately 64 additional subjects with CDI will be enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours for 10 days and will be followed for 28 ± 2 days for recurrence. The two treatments will be identical in appearance, dosing times, and the number of capsules administered to maintain the blind. Subjects in both segments will be evaluated for clinical and sustained clinical cure, safety, and tolerability. All subjects in both segments will have stool samples tested for microbiome profiles.  Additional information about the trial, including eligibility criteria, can be found at www.clinicaltrials.gov (Study identifier: NCT04247542).

About Clostridioides Difficile Infection (CDI).  Clostridioides (formerly Clostridium) difficile, also known as C. difficile or C. diff, is one of the most common causes of healthcare-associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine).  Recent estimates suggest C. difficile approaches 500,000 infections annually in the United States and are associated with approximately 20,000 deaths. (Guh, 2020, New England Journal of Medicine).  Based on internal estimates including a recurrence rate of approximately 20%, we believe the annual incidence in the U.S. approaches 600,000.

About the C Diff Foundation:  The Company recognizes the month of November as                    C. Difficile Awareness Month as designated by the US Centers for Disease Control and Prevention (CDC) and supports the work of the C Diff Foundation in educating and advocating for the Prevention, Treatments, Clinical Trials, and Environmental Safety of Clostridioides difficile (C.difficile) Infections worldwide. https://cdifffoundation.org/.  The C Diff Foundation recently announced the release of the C diff and You app, available from the Apple Store (apple.com) and Google Store (play.google.com).  Developed with patients, family members, and caregivers in mind, the app provides information about C. difficile infection prevention, treatments, clinical trials, support, guidelines, environmental safety, and nutrition.

The U.S. Center for Diseases Control 2019 Update on Antimicrobial Resistance.  https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf  CDC reported that more than 2.8 million antibiotic-resistant infections occur in the U.S. each year and more than 35,000 people die as a result, nearly twice as many annual deaths as previously reported by CDC in 2013. These deaths are attributed to antimicrobial-resistant pathogens including Enterococcus (including vancomycin-resistant strains or VRE), Staphylococcus (including methicillin-resistant strains or MRSA), and Streptococcus (including antibiotic-resistant strains), which are the targets of the Company’s antibiotic pipeline currently in preclinical development and also eligible for QIDP and FDA-Fast-Track-Designation for priority review.

About ibezapolstat, FDA QIDP, and Fast Track Designation.  In June 2018, FDA granted Qualified Infectious Disease Product (QIDP) designation to ibezapolstat as an oral treatment for patients with CDI.  In addition, in January 2019, FDA granted Fast Track designation to ibezapolstat for the oral treatment for patients with CDI.

FDA’s QIDP Designation provides that ibezapolstat will be eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (the GAIN Act). These incentives include Priority Review and eligibility for Fast Track status, the latter of which Acurx has already applied for and been granted by the FDA.  Further, if ultimately approved by the FDA, ibezapolstat is eligible for an additional five-year extension of Hatch-Waxman marketing exclusivity.

FDA Fast Track Designation is a process designed to facilitate the development and expedite the regulatory pathway of new drugs to treat serious or life-threatening conditions and that fill a high unmet medical need. Ibezapolstat is a novel, first-in-class, orally administered antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors in clinical development by Acurx to treat bacterial infections.

About DNA polymerase IIIC (pol IIIC).  Working in scientific collaboration with WuXi AppTec, Acurx has identified additional potential therapeutic candidates to add to its pipeline of DNA pol IIIC inhibitors. Nonclinical research has established the mechanism of action of ibezapolstat as the selective inhibition of the enzyme DNA polpol IIIC, which is required for bacterial replication and pathogenesis. This enzyme is found only in certain Gram-positive bacteria, including C. difficile as well as the pathogens Enterococcus (including vancomycin-resistant strains or VRE), Staphylococcus (including methicillin-resistant strains or MRSA), and Streptococcus (including antibiotic-resistant strains). Accordingly, chemically related molecules with the same mechanism of action as ibezapolstat have the potential to treat a variety of serious systemic Gram-positive infectious diseases.

About Acurx Pharmaceuticals, LLC.  Acurx Pharmaceuticals is a privately-held clinical-stage biopharmaceutical company focused on developing new antibiotics for difficult-to-treat infections. Acurx’s approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes early-stage antibiotic candidates that target other Gram-positive bacteria, including Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE), and Penicillin-Resistant Streptococcus pneumoniae (PRSP).

For more information, please visit our website at www.acurxpharma.com.

Any statements in this press release about our future expectations, plans, and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other factors. In addition, the forward-looking statements included in this press release represent our views as of November 5, 2020.  We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.

Investor Contact:
Acurx Pharmaceuticals, LLC
David P. Luci, Co-Founder & Managing Partner
917-533-1469; davidluci@acurxpharma.com

SOURCE Acurx Pharmaceuticals, LLC

C diff and You app. Available From the Apple Store and Get It On Google

C diff and You

Available From Apple Store and
Get It On Google

Eliminate the hours spent searching for
C. diff. infection information, definitions, and more on the web. Patients, with family members, caregivers,  and friends, are overwhelmed, and absolutely exhausted.

 

 

No one diagnosed with a CDI, and feeling so poorly,  has the time or energy to sit in front of a computer searching, reading, and clicking through pages of information.

Stay connected, stay up-to-date with the C Diff Foundation.

“None of us can do this alone ~ All of us can do this together.”

Download C diff and You today to learn more about
C. diff. (Clostridioides difficile, C. difficile, CDI) infection prevention, treatments, clinical trials, support, environmental safety, and more.