FDA approves first microbiome therapeutic for C. diff infection in adults

c. diff

On April 26, the U.S. Food and Drug Administration (FDA) approved the first investigational microbiome therapeutic for treating recurrent Clostridioides difficile infection in adults.

The treatment, called VOWST, was developed by Seres Therapeutics, a member of the Biotechnology Innovation Organization (BIO), and Nestlé Health Science.

C. diff is a serious and potentially life-threatening bacterial infection of the colon, causing severe diarrhea, fever, and abdominal pain. It is most commonly associated with the use of antibiotics, which can disrupt the normal balance of bacteria in the gut. This allows C. difficile to grow out of control. In addition to being complicated to treat, CDI often recurs even after successful initial treatment.

graphic showing the risk factors for c. diff infections in adults
Are you at risk for C. diff? (Source: CDC)

What is VOWST?

VOWST is a novel oral microbiome therapeutic designed to restore the natural balance of bacteria in the gut and prevent CDI from recurring.

The therapy consists of a carefully selected blend of fecal microbiota spores, or the protective outer layers of bacterial spores, from healthy donors. The spores are designed to survive the acidic environment of the stomach and colonize the gut, where they can help restore the diversity and function of the gut microbiome.

The FDA’s approval is based on data from a randomized, placebo-controlled, double-blind Phase 3 trial that evaluated the efficacy and safety of VOWST in adults with recurrent C. diff infections.

The trial showed VOWST significantly reduced the incidence of these recurrent infections in patients compared to placebo, with 88% of treated individuals recurrence-free at eight weeks. The drug was well-tolerated, with a safety profile similar to the placebo’s.

VOWST offers C. diff treatment and prevention

VOWST is the first oral microbiome therapeutic approved for preventing recurrent C. diff infections in adults who have completed antibiotics. The drug offers a targeted, effective, and safe approach to restoring the gut microbiome. The drug was also shown to prevent recurrent CDI in high-risk patients.

“Since being founded by Flagship Pioneering over a decade ago, Seres has led the development of microbiome therapeutics, and today’s FDA approval of VOWST as the first orally administered microbiota-based therapeutic for the prevention of recurrent C. difficile infection marks a tremendous milestone for the patient community and for Seres,” said Eric Shaff, Seres President and CEO.

Seres and Nestlé Health Science teamed up in July 2021 to jointly sell VOWST in the U.S. and Canada. Nestlé Health Science is leading the commercialization efforts, using its global pharmaceutical business, infrastructure, sales force, and payer access team.

Seres Therapeutics and Nestlé Health Science plan to launch the therapy in the U.S. by June.

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