Fecal Microbiota Transplant Therapy May Change Paradigm of C. Difficile Treatment

Fecal microbiota, live-jslm (Rebyota; Ferring Pharmaceuticals), a class of therapy known as fecal microbiota transplant (FMT) used to treat Clostridioides difficile infection (CDI), has seen early positive adoption from gastroenterologists and infectious disease specialists in the first month post-launch, according to a statement by Spherix Global Insights.

According to research by Spherix Global Insights Market Dynamix Clostridioides difficile (US), more than 60% of gastroenterologists believe that FMT therapy will dramatically change the paradigm of CDI treatment within the next 5 years. It was also reported that there are 2 additional FMT treatments in development, which includes SER-109 (Seres Therapeutics; Aimmune) and VE303 (Vedanta Biosciences). CP101 (Finch Pharmaceuticals) was recently discontinued.

The company estimates that SER-109 will be able to challenge fecal microbiota, live-jslm in the CDI industry. With a first-to-market advantage, physicians said that fecal microbiota, live-jslm, had high satisfaction, according to the report.

However, the mode of administration, as well as storage and handling requirements, may hinder fecal microbiota, live-jslm. It is administered as a single dose enema in a physician’s office, which some physicians said patients may not be comfortable with. However, other physicians said that after recurring disease, patients might be more open to this treatment administration.

Additionally, fecal microbiota, live-jslm should be stored in an ultracold freezer that can be thawed in a standard refrigerator up to 5 days before usage. The requirements for handling are not uncommon in the CDI treatment landscape, but this could limit the number of physicians who can accommodate the handling and storage limitations.

However, SER-109, which is set for an FDA Prescription Drug User Fee Act decision in April 2023, is an oral capsule. In data from the ECOSPOR III (NCT03183128) trial, individuals take 4 marching oral capsules of SER-109 once daily over 3 consecutive days. SER-109 should be taken after antibiotic standard of care and a single bowel prep, of 10 oz of magnesium citrate or 250 mL of GoLytely the day before SER-109 dosing.

Both SER-109 and fecal microbiota, live-jslm showed a significant reduction in recurrence of CDI.

Physicians in the survey by Spherix had a large preference for SER-109, however, for patients both options are an improvement to the standard of care, reducing the symptoms for those who have CDI. The company will continue to monitor the launch of fecal microbiota, live-jslm and the pending approval of SER-109.

Market Dynamix is an independent service that provides analysis of markets anticipated to experience a paradigm shift within the next 3 to 5 years. Spherix Global Insights is a provider of market research, business intelligence, and advisory service to global life sciences.

Reference

Ferring Pharmaceuticals' 1st in class C. diff treatment, Rebyota, experiences a positive early launch ahead of potential competition, according to Spherix Global Insights. News release. PR Newswire. March 17, 2023. Accessed March 23, 2023. https://www.prnewswire.com/news-releases/ferring-pharmaceuticals-1st-in-class-cdiff-treatment-rebyota-experiences-a-positive-early-launch-ahead-of-potential-competition-according-to-spherix-global-insights-301775185.html