2023-04-27| Trials & Approvals

Nestle and Seres Land First-Ever Fecal Microbiota Product Approval From FDA

by Reed Slater
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Nestlé Health Sciences and Seres Therapeutics landed a huge approval on Wednesday when the FDA gave the nod to the jointly developed, orally administered fecal microbiota therapy, Vowst. The therapy, approved to prevent recurrent Clostridioides difficile infection (rCDI), marks the first orally administered fecal microbiota therapy ever to gain approval. 

Related Article: Rebyota Passes Through FDA To Become First Approved Fecal Microbiota Product

Fecal Microbiota Product: An Addition to Antibiotics

CDI is one of the most common intestinal tract infections accounting for between 15,000 and 30,000 deaths in the U.S. every year. People over 65, those with weakened immune systems, and those living in nursing homes are at an increased risk of contracting the infection.

The most common treatment for CDI is antibiotics, but using antibiotics alone to treat the condition can come with some risks. Antibiotics can change the balance of microorganisms in the gut, allowing the C. difficile bacteria to multiply and worsen the condition, causing diarrhea, fever, organ failure, and even death. 

To prevent patients from consistently taking antibiotics for rCDI, Seres took a centuries-old approach with a new twist in the form of its fecal microbiota therapy, Vowst. The therapy is manufactured using live bacteria from human fecal matter donated by qualified individuals. The FDA approved the therapy to prevent rCDI in patients over 18 after undergoing standard-of-care antibiotic treatment. 

What really sets Vowst apart from traditional fecal transplants, which in the past have received limited regulatory oversight, is that it is an oral pill instead of an enema. In November last year, Ferring Pharmaceuticals’ rCDI med, Rebyota, received FDA approval for the same condition but may have met some market resistance because it is an enema. 

Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., said, “The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening.”

Vowst’s Performance in the Clinic

Seres and Nestlé took Vowst through the gauntlet of clinical trials prior to the FDA’s approval of the product, and throughout the process, the therapy showed promise in its potential to prevent rCDI.

In the ECOSPOR III trial, Vowst met the primary objective of reducing CDI recurrence compared to a placebo. At eight weeks, 88% of participants taking Vowst were recurrence-free, compared to 60% in the placebo group. A longer time frame showed similar results, with 79% of participants in the Vowst group recurrence-free at six months, compared to 53% for those taking a placebo. 

Because Vowst contains live bacteria, there is a risk of transmitting infectious pathogens, but the most common adverse reactions throughout the clinical trials were abdominal distension, fatigue, and constipation, all of which were experienced, albeit to a lesser extent, in the placebo group. 

Vowst’s approval is exciting news in the CDI space and provides Seres the opportunity to continue working on the rest of its infection protection and immune modulation therapy pipeline. In addition to the pride of its first FDA-approved therapy, its partnership with Nestlé will bring Seres $125 million as a regulatory milestone achievement.

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