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

The FDA has signed off Seres Therapeutics Inc's 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.