Benzinga | Jun 1, 2021 11:48AM EDT

Seres Therapeutics Gets FDA Green Signal to Start SER-155 Human Trials

* The FDA has signed off Seres Therapeutics Inc's (NASDAQ:MCRB) Investigational New Drug (IND) application for SER-155 to initiate Phase 1 trial.

* SER-155 is a cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal antibiotic-resistant bacterial infections, bacteremia, and graft-versus-host disease (GvHD).

* The Phase 1b study is designed to include approximately 70 patients to evaluate safety and tolerability before and after hematopoietic stem cell transplantation.

* Additionally, the engraftment of SER-155 bacteria (a measure of pharmacokinetics) and the efficacy of SER-155 in preventing infections and GvHD will be evaluated.

* Price Action: MCRB shares are down 4.12% at $20.24 during the market session on the last check Tuesday.