New Fecal Microbiota Treatments for Preventing Recurrent C.diff Infection
Second fecal microbiota product to receive FDA approval is taken via oral capsule; two more are in the pipeline that also aim to rebalance the gut microbiome
Clostridioides difficile (C. difficile) is a bacterium that causes gut infection and inflammation of the colon, resulting in diarrhea, abdominal pain and fever. People often get C. diff infections within a month of taking antibiotics. According to the Centers for Disease Control (CDC), one in six people who have had a C. diff infection will get it again within the subsequent 6 to 8 weeks.
Seres Therapeutics, Inc. and Nestlé Health Science's Vowst (fecal microbiota spores) treatment was approved by the U.S. Food and Drug Administration (FDA) for the prevention of recurrence of Clostridioides difficile (C. difficile) infection in people 18 years of age or older after antibiotic treatment for C. diff infection has been completed. It is not to be used as a treatment of C.diff infection.
Vowst is a capsule containing stool from a healthy donor and works by changing the balance of microorganisms in the gut. Vowst is the first fecal microbiota product to be taken orally: dosage is four capsules taken once a day for three consecutive days.
Although the donors and donated stool are tested for a panel of transmissible pathogens, Vowst may carry a risk of transmitting infectious agents, including food allergens. The effectiveness of Vowst was evaluated in a small study in which 89 participants received Vowst and 93 participants received placebo. During the 8 weeks after treatment, just 12.4% of Vowst-treated participants experienced recurrence compared with 39.8% of placebo-treated participants. The application was granted Priority Review, Breakthrough Therapy and Orphan designations.
Read the FDA Press Release
Read more about the treatment in this Associated Press news release:
https://health.wusf.usf.edu/health-news-florida/2023-04-27/fda-approves-a-fecal-transplant-capsule-to-treat-c-diff-gut-infections
Vowst is expected to be on the market by summer 2023 and will cost about $17,500 per treatment course. Seres executives plan to set up a patient assistance program for those who cannot get the drug covered through insurance. The company estimates commercial insurers will cover more than half of people taking the drug, but cautioned it might take time before it is broadly covered.
https://www.biopharmadive.com/news/seres-fda-approval-microbiome-c-diff-infection/648672/
In November 2022, Ferring Pharmaceuticals' Rebyota became the first microbiota product to be approved by the FDA and is administered by transplantation instead of orally. It is a one-time dose for prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
https://www.fda.gov/vaccines-blood-biologics/fecal-microbiota-products
Products in the Pipeline
Vendanta Biosciences is developing fecal microbiota products that use manufacturing techniques starting with live cell banks, rather than from donated feces. Clinical trials are moving forward for two drugs, one for ulcerative colitis (phase 2 trial) and the other for recurrent Clostridioides difficile (phase 3 trial).
https://www.bizjournals.com/boston/news/2023/04/25/vedanta-biosciences-c-diff-fundraise-puretech.html