Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults.
Vowst is an orally administered microbiota-based therapeutic, previously known as SER-109, and is indicated for the prevention of recurrence of CDI in people aged 18 years and above following an antibacterial treatment for recurrent CDI (rCDI). It is not indicated to treat CDI.
The regulator had previously granted breakthrough therapy and orphan drug designations to Vowst.
Seres president and CEO 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.”
The regulatory approval was supported by a Phase III development programme which included the ECOSPOR III and ECOSPOR IV trials.
The primary objective of the randomised placebo controlled, multi-centre ECOSPOR III trial was to show a reduction of CDI recurrence in individuals with rCDI.
Vowst reduced CDI recurrence, with 88% of participants recurrence-free eight weeks after receiving treatment compared to 60% of those administered a placebo.
Seres and Nestlé Health Science signed an agreement in July 2021 to work together for the commercialisation of Vowst in Canada and the US.