FDA Gives Green Light to Seres Therapeutics and Nestlé Health Science’s VOWSTTM: Solution to Combat Recurrent C. difficile Infection in Adults!

The U.S. Food and Drug Administration (FDA) has granted approval to VOWSTTM (fecal microbiota spores, live-brpk) – formerly known as SER-109 – a revolutionary microbiota-based therapeutic developed by Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science.

This orally administered therapeutic is designed to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST marks a major milestone in the fight against rCDI, offering a new way to reduce the chances of recurring infection and its associated health risks.

Today marks a tremendous milestone for Seres and the patient community, with the FDA approval of VOWST, the first-ever orally administered microbiota-based therapeutic for the prevention of recurrent C. difficile infection. Founded by Flagship Pioneering over a decade ago, Seres has been a pioneer in microbiome therapeutics.

We are deeply grateful to the patients, caregivers, clinical investigators, and employees who helped make this momentous achievement possible. Through VOWST, we and Nestlé Health Science now have the opportunity to prevent recurrence in a broad group of adult rCDI patients, including those who have experience a first recurrence.

At Nestlé Health Science, we are dedicated to providing innovative treatments for those suffering from gastrointestinal disorders. That’s why we are excited to announce our strategic collaboration with Seres, which will bring VOWST to market in June. This groundbreaking product will help healthcare professionals address the needs of patients and make a real difference in their lives. We are confident that VOWST will make a positive impact on those with gastrointestinal issues.

Recurrent Clostridium difficile infection (CDI) represents a significant and growing unmet need, with an estimated 156,000 episodes in the United States in 2023 according to the U.S. Centers for Disease Control and Prevention (CDC). Severe illness and death can result from hospital-acquired infections of this type, making it a leading cause of concern for healthcare providers.

Recurrent C. difficile infection can be debilitating and life-threatening, and antibiotics alone are not enough to address the root cause – dysbiosis of the gut microbiome. Thankfully, VOWST has now been approved as an important new oral treatment option for this disease, allowing doctors like Carl Crawford M.D., Assistant Professor of Clinical Medicine at Weill Cornell Medical College, to offer a new and potentially life-saving solution to recurrent CDI patients.

Recurrent C. difficile infection can be hugely disruptive to patients’ lives, causing immense physical and emotional suffering and fear of future recurrences. Thankfully, new treatment options are now available that address this key concern, offering hope for the prevention of additional CDI recurrences and improved quality of life. As Christian John Lillis, Executive Director at the Peggy Lillis Foundation for C. diff Education and Advocacy, puts it: “Patients have been waiting for this breakthrough.”

VOWST Phase 3 Study Data

The FDA’s approval of VOWST was a major milestone in medicine, backed by an extensive Phase 3 development program including the ECOSPOR III and IV studies. This innovative treatment had previously been granted Breakthrough Therapy and Orphan Drug Designations by the FDA, further emphasizing its potential to revolutionize medical care.

ECOSPOR III, a multicenter, randomized, placebo-controlled study in individuals with rCDI, revealed that VOWST is an effective treatment to reduce the recurrence of CDI. The study, which was published in the New England Journal of Medicine, demonstrated that VOWST reduced CDI recurrence at eight weeks, with 88% of individuals being recurrence-free at that time compared to only 60% in the placebo group.

At six months post-treatment, 79% of the VOWST group had no recurrence versus 53% of the placebo group. Furthermore, no treatment-related serious adverse events were observed in the VOWST group, and the frequency of treatment-related adverse events was similar between the two groups. Common adverse reactions through eight weeks included abdominal distention, fatigue, constipation, chills, and diarrhea.

ECOSPOR IV was a groundbreaking study that opened the door for the approval of a new treatment for recurrent Clostridioides difficile (rCDI). The study’s results, published in the JAMA Network Open, demonstrated the safety and efficacy of VOWST in 263 adult participants. Thanks to this research, VOWST is now available to those suffering from rCDI, providing hope and relief.

Seres and Nestlé Health Science are dedicated to ensuring that patients who have been prescribed VOWST are able to access it. To make this possible, they have developed comprehensive access programs that will be unveiled at launch. Now, everyone who needs VOWST can benefit from its life-changing effects.

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