The U.S. FDA has approved its first fecal microbiota treatment. Rebyota (fecal microbiota, live-jslm), from privately held Ferring Pharmaceuticals Inc., is now approved to prevent recurring Clostridioides difficile infection (CDI) in adults. The Nov. 30 approval came about two months after the FDA’s Vaccines and Related Biological Products Advisory Committee voted 13-4 to support the microbiome therapy’s effectiveness in reducing recurrent CDI in adults after antibiotic treatment for recurrent CDI.
The race to become the first microbiome-based therapy to reach the market continues between two companies. A positive view by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee on Sept. 22 for RBX-2660 in preventing recurrent Clostridium difficile infection kept Ferring Pharmaceuticals Inc.’s microbiota-based live biotherapeutic moving forward.
Unveiling further positive data for SER-109 in preventing recurrent Clostridium difficile infection at Digestive Disease Week (DDW) over the weekend, Seres Therapeutics Inc. reiterated plans to file a BLA with the U.S. FDA in mid-2022. Should the FDA accept the application and grant priority review – SER-109 has breakthrough and orphan status – the medicine could be the first microbiome-based therapy to reach the market.
Antibiotics continue to take a beating as top-line results from Summit Therapeutics Inc.’s phase III study of ridinilazole failed to meet the primary endpoint for sustained clinical response and treating C. difficile infection (CDI). Looking for an upside on its lead candidate’s results, the company noted participants treated with ridinilazole had substantially less recurrence of CDI, the most common cause of diarrhea in hospitalized patients, as compared to those who were administered vancomycin (nominal p-value = 0.0002).
LONDON – Microbiome specialist Enterobiotix Ltd. closed a $21.5 million series A to advance development of its live bacteria fecal transplant drug pipeline.
Proceeds from Vedanta Biosciences Inc.’s just closed $68 million series D financing will be used for a phase III study of the company’s lead candidate, VE-303, composed of eight clonal human commensal bacterial strains to give colonization resistance for treating Clostridioides difficile (C. diff) infection, and also for a phase II study of VE-202, made up of 16 clonal human commensal bacterial strains for treating inflammatory bowel disease.
HONG KONG – A research team at the Chinese University of Hong Kong (CUHK) has developed a fully automated, low-cost and rapid microrobotic diagnostic system that can be used with multiple pathogens, including COVID-19. The system works by integrating fluorescent microrobots with an external magnetic actuation system to detect pathogens in patient samples.
DUBLIN – Finch Therapeutics Inc. closed a $90 million series D round to take its oral microbiome therapy, CP-101, into late-stage clinical development and registration in chronic Clostridioides difficile infection and to move two additional programs, for chronic hepatitis B virus infection and autistic spectrum disorder, into the clinic.
Mark Wilcox, professor of medical microbiology at the University of Leeds, said Seres Therapeutics Inc.’s top-line phase III data with oral microbiome therapeutic SER-109 against recurrent Clostridium difficile infection (CDI) are “about as good as it gets” in the tough-to-treat patient population.
DUBLIN – Top-line data from a phase II pivotal trial of CP-101, Finch Therapeutics Group Inc.’s oral microbiome therapy for chronic Clostridioides difficile infection (CDI), are technically good, but how good is the big question.
