Doctors Come Together at FDA During C.diff Awareness Month, Advocate for Treatments

Doctors Come Together at FDA During C.diff Awareness Month, Advocate for Treatments

Progenabiome plans for continued discussions at Malibu Microbiome Meeting in March 2020

News provided by

Progenabiome

MALIBU, Calif., Nov. 13, 2019 /PRNewswire/ — Several doctors spoke before the FDA in Washington D.C. on November 4, advocating for C.diff treatment improvements. Among those in attendance were gastroenterologists Paul Feuerstadt (Yale), Colleen Kelly (Brown), Sahil Khanna (Mayo Clinic), Jessica Allegretti (Harvard), Zain Kassam (Finch), and Sabine Hazan (Progenabiome). They continue to collaborate in hopes of finding answers.

Challenging C.diff Beliefs

Paul Feuerstadt, MD (New Haven, CT) warns FDA of potential dangers in limiting patient access to FMT treatment; mentions incident of an individual who attempted to perform FMT on themself and how dangerous that could be -- Nov 4, 2019, Washington D.C.
Paul Feuerstadt, MD (New Haven, CT) warns FDA of potential dangers in limiting patient access to FMT treatment; mentions incident of an individual who attempted to perform FMT on themself and how dangerous that could be — Nov 4, 2019, Washington D.C.
the microbiome
Doctors from all over the country unite at the FDA hearing on the Use of Fecal Microbiota for Transplantation (FMT) to Treat Clostridium difficile Infection Not Responsive to Standard Therapies. Left to Right: Jessica Allegretti, MD (Boston, MA), Colleen Kelly, MD (Providence, RI), Stacy Kahn, MD (Boston, MA), and Sabine Hazan-Steinberg, MD (Malibu, CA) — Nov 4, 2019, Washington D.C.

Clostridioides difficile infection (CDI) burdens millions worldwide, causing symptoms from diarrhea to life-threatening colon inflammation. With recurrence rising despite existing treatments, CDI kills 41 individuals daily in the US alone.

“What if we were wrong about C.diff?,” questions Progenabiome CEO Dr. Sabine Hazan. “What if the bug killing thousands every year doesn’t spread in hospitals but develops by what we put in our body?” After her lab found non-toxigenic C.diff in 100% of 121 random asymptomatic patients, Hazan wonders if hand-to-mouth transmission of bacteria actually causes CDI. She argues for further clinical investigation.

FDA Hearing on Use of FMT to treat CDI

Providers, scientists, industry, and patients provided testimony at the FDA hearing:

  • Openbiome says enforcement discretion serves patients; shows 79% FMT success rate with their product
  • Rebiotix expresses concerns of costs of clinical trials, delayed drug development and decreased study enrollment as a result of stool banks
  • Amanda Kabage (Univ. of Minnesota) says FMT saves tens-of-thousands, many excluded from clinical trials
  • Diane Hoffmann, JD (Univ. of Maryland) says costs will limit access if enforcement discretion discontinues with FDA drug approval
  • Paul Feuerstadt, MD says limited access can be dangerous, as individuals have tried to perform FMT on themselves

While some speakers argue for increased studies to show definitive efficacy, several doctors show existing data to support FMT.

  • Colleen Kelly, MD shares post-FMT data:
    • 75% (263 respondents) “sustained cure” in 3-year multi-center follow-up study
    • 95% (152 “initially cured” patients) remained cured 6 months post-FMT
  • Sahil Khanna, MD shares recurrence rates:
    • 8-16% rCDI post-FMT vs. 50-60% rCDI after antibiotic treatment
  • Paul Feuerstadt, MD looks forward to data from active phase 3 trials; high-quality data-supported therapies are essential
  • Byron Vaughn, MD no longer questions FMT effectiveness
  • Sabine Hazan, MD emphasizes patient rights above all; with provider guidance and informed consent, patients should have a choice

Doctors Working Together for Progress

Abovementioned Drs. Feuerstadt, Kelly, Khanna, Allegretti, Kassam, and Hazan, will join others including Thomas Borody (CDD), Neil Stollman (UCSF), as well as NIST and NIH representatives to continue the conversation about C.diff, FMT, and other microbiome topics at the Malibu Microbiome Meeting on March 28-29, 2020.

Additionally, Progenabiome hopes to unite doctors worldwide for a global microbiome clinical study in hopes of finding more answers about the role of the gut flora in C.diff and other diseases.

For more: www.progenabiome.com / Twitter / Facebook / LinkedIn

Contact: Stephanie Davis, [email protected]

SOURCE Progenabiome

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