Vowst (faecal microbiota spores, live-brpk), previously known as SER-109, is an orally administered microbiota-based therapeutic, indicated for the prevention of recurrence of CDI in adults, following antibacterial treatment for recurrent CDI (rCDI)
FDA approves Vowst to prevent recurrent CDI. (Credit: Steve Buissinne from Pixabay)
Seres Therapeutics and Nestlé Health Science have secured the US Food and Drug Administration (FDA) approval for Vowst to prevent the recurrence of C. difficile Infection (CDI).
Vowst (faecal microbiota spores, live-brpk), previously known as SER-109, is an orally administered microbiota-based therapeutic.
The drug is indicated for the prevention of recurrence of CDI in people, aged 18 years and above, following antibacterial treatment for recurrent CDI (rCDI).
Vowst, which has been granted Breakthrough Therapy and Orphan Drug Designations by the FDA, is not indicated for the treatment of CDI.
In July 2021, Seres and Nestlé Health Science signed an agreement to jointly commercialise Vowst in the US and Canada.
Nestlé Health Science chief executive officer Greg Behar said: “Our strategic collaboration with Seres is part of Nestlé Health Science’s ongoing commitment to advancements in the gastrointestinal space to address unmet patient needs.
“Our teams have vast experience in gastrointestinal disorders and are poised to engage with healthcare professionals to start addressing this critical need for patients. We expect VOWST to be available in June and look forward to helping patients.”
According to the US FDA, Recurrent CDI represents a significant unmet need and is a leading cause of hospital-acquired infection that can result in severe illness and death.
The FDA approval of Vowst is supported by the Phase 3 development programme, which includes the ECOSPOR III and ECOSPOR IV studies.
ECOSPOR III was a multicentre, randomised, placebo-controlled study, designed to evaluate Vowst for reducing CDI recurrence in individuals with rCDI.
In the study, Vowst reduced CDI recurrence, with around 88% of individuals being recurrence-free at eight weeks post-treatment, compared to 60% for those who received a placebo.
In addition, 79% of the Vowst group showed to be recurrence-free at six months post-treatment, compared to 53% in the placebo group.
The study showed a frequency of treatment-related adverse events that were similar to the Vowst and placebo arms, with no treatment-related serious adverse events.
The most common adverse reactions include solicited events of abdominal distention, fatigue, constipation, chills, and unsolicited event of diarrhoea.
Seres president and chief executive officer Eric Shaff said: “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.
“We are deeply grateful to the patients, caregivers, clinical investigators, and employees who contributed to the discovery, development, and approval of Vowst.
“With Vowst, we and Nestlé Health Science have the opportunity to prevent recurrence in a broad group of adult rCDI patients, including those who have experienced a first recurrence.”