Oral Microbiome Therapeutic Gets Priority Review for Recurrent C difficile Infection

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for the oral microbiome therapeutic SER-109 for the treatment of recurrent Clostridioides difficile infection (CDI).

SER-109 contains purified bacterial spores of multiple Firmicute species obtained from the stool of healthy human donors. The BLA is supported by data from the double-blind, randomized, placebo-controlled phase 3 ECOSPOR III study (ClinicalTrials.gov Identifier: NCT03183128), which evaluated the efficacy and safety of SER-109 in 182 adults who had 3 or more episodes of CDI within 12 months, inclusive of the current episode. Patients were randomly assigned to receive 4 capsules of SER-109 or placebo orally daily for 3 days after standard-of-care antibiotic treatment.

Results showed that treatment with SER-109 met the primary endpoint demonstrating superiority to placebo in reducing CDI recurrence. At 8 weeks post treatment, 88% of patients in the SER-109 arm did not have CDI recurrence compared with 60% of those in the placebo arm. At 24 weeks post treatment, 79% of patients remained free from CDI recurrence compared with 53% of those in the placebo arm. 

The application also includes efficacy and safety data from ECOSPOR IV (ClinicalTrials.gov Identifier: NCT03183141), an open-label extension study, which evaluated SER-109 in 263 adults with recurrent CDI. Results showed that 91% and 86% of patients treated with SER-109 had sustained clinical response at 8 and 24 weeks, respectively.

A Prescription Drug User Fee Act target date of April 26, 2023 has been set for the application.

This article originally appeared on MPR