Seres Therapeutics’ product will be known as Vowst (fecal microbiota spores, live-brpk), and the company stated that it expects to launch the treatment in June of this year.
The US Food and Drug Administration (FDA)’s decision to approve the product was based on a Phase III study that showed the therapy’s ability to reduce C. difficile infection (CDI) recurrence.
The data showed that 88% of individuals were CDI recurrence-free at eight weeks, compared to 60% in those receiving placebo. At six months post-treatment, 79% of those who received Vowst were recurrence-free, compared to 53% of placebo recipients.
Vowst is delivered orally, with patients taking four capsules once per day for three consecutive days. The product contains live bacteria and is manufactured from human fecal matter that has been donated by qualified individuals. The product becomes the first approved fecal microbiota product that is taken orally.
The donors and the donated fecal matter are tested for transmissible pathogens prior to dosing, though the FDA noted in its approval statement that this does not mean there is no risk of the product transmitting infectious agents.
Seres will jointly commercialize the product alongside Nestle Health Science, after the two partners arranged a deal in 2021. Nestle will take the lead on commercializing the product, as the company agreed a $175m (€160m) upfront licensing fee with Seres. At the time, the companies stated that the value of the deal to Seres could be upwards of $500m, and that all profits would be split 50/50.
The day after announcing the approval of its product, Seres outlined that it had received $250m in debt financing from Oaktree Capital Management. The company will receive the loan through an upfront tranche of $110m, followed by smaller payments based on Vowst sales targets.
Seres stated that the funds will be used to support the commercial launch of Vowst. Oaktree will also hold the option to provide $50m to support “future business development activities.”
As part of the announcement, David Arkowitz, chief financial officer at Seres, said that the company would use the capital to also advance SER-155. Seres is currently putting the potential treatment through Phase Ib trials to reduce the incidence of gastrointestinal infections, bloodstream infections, and graft versus host disease in individuals undergoing allogeneic hematopoietic stem cell transplantation.