Peak Loop-To Microbiome Innovation Therapy reaches critical Phase 3 clinical endpoint.

CDI is one of the top three most urgent antibiotic-resistant bacterial threats in the United States and the leading cause of infection in U.S. hospitals.
CDI is associated with debilitating diarrhea, which significantly affects the quality of life of patients.
has been the most commonly used drug for patient management since the discovery of Thyrobacteria more than 40 years ago.
, the current treatment still leaves a large number of patients with relapses.
SER-109 is a research, oral, bio-origin microbiome therapy drug designed to reduce the recurrence of CDI, so that patients can restore the diversity of the gastrointestinal microbiome by breaking the vicious cycle of CDI recurrence, to achieve sustained clinical remission.
SER-109 consists of purified bacterial spores from a variety of thick-walled bacteria.
FDA has granted SER-109 breakthrough therapy and orphan drug qualification for treatment of CDI.
in the SER-109 trial, 182 patients with multiple CDI were treated with SER-109 or a placebo, and all were treated with standard antibiotics.
results showed that SER-109 reached the primary endpoint of the trial, with a recurrence rate of 11.1% in the SER-109 group and 41.3% in placebo patients after eight weeks of treatment.
the SER-109 treatment group was 0.27 (95% CI -0.15 to 0.51) compared to the placebo group.
results of phase 3 clinical trials of SER-109 (Photo: Seres Therapeutics website) References: seres Therapeutics Announces Positive Topline Results from SER-109 Phase 3 ECOSPOR III Study in Recurrent C. difficile Application. Retrieved August 10, 2020, from.