Seres Therapeutics Inc (MCRB)

[crudeoil24]

Seres Therapeutics Phase 3 SER-109 Study Meets Main Endpoint >MCRB
7:06 am ET August 10, 2020 (Dow Jones) Print
By Colin Kellaher

Seres Therapeutics Inc. on Monday said a pivotal phase 3 study of its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection met its primary endpoint.

The Cambridge, Mass., developer of biological drugs said SER-109 showed a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared with placebo, adding that the drug was well tolerated, with a safety profile comparable to placebo.

Seres also said the study's efficacy results exceeded the U.S. Food and Drug Administration's statistical threshold that could allow the single study to fulfill efficacy requirements for a biologics license application, and the company said it plans to meet with the agency to discuss filing for product approval as soon as possible.

C. difficile, an antibiotic-resistant bacterium, is a leading cause of hospital-acquired infection in the U.S.

Shares of Seres, which closed Friday at $4.64, more than tripled to $14.20 in premarket trading Monday.

Write to Colin Kellaher at [e-mail]