FDA accepts Seres’ rCDI therapeutic BLA for priority review

The US Food and Drug Administration (FDA) has accepted Seres TherapeuticsBiologics License Application (BLA) for SER-109 for prevention of recurrent C. difficile infection (rCDI) for priority review.

The regulatory agency’s decision to approve the therapy is expected on April 26 next year.

Additionally, the FDA said it does not currently plan to hold an advisory committee meeting to discuss the BLA for SER-109.

The application is based on findings from the completed Phase III development program, including the ECOSPOR III and ECOSPOR IV clinical trials.

The randomized, placebo-controlled, multicenter study ECOSPOR III (SERES-012) enrolled 182 adult patients with rCDI.

According to the trial data, 88% of participants in the SER-109 arm were free of C. difficile recurrence at eight weeks versus 60% in the placebo arm.

The ECOSPOR IV (SERES-013) study evaluated the commercial dose of SER-109 in 263 patients with rCDI.

The safety profile of the drug was well tolerated in the trial, and a sustained clinical response of 91% was reported at eight weeks in the entire group.

An investigational candidate for oral microbiome therapy, SER-109 has purified Firmicutes spores for the treatment of rCDI.

Seres Therapeutics President and CEO Eric Schaff said, “We are working as quickly as possible to bring this first-of-its-kind oral microbiome therapy to the patients most in need, if approved.

“The milestone is the result of tremendous hard work and persistence by our team, and we look forward to cooperating with the FDA through the ongoing review process.”

Last July, the company and Nestlé Health Science signed an agreement to jointly sell SER-109 in the US and possibly Canada.