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

by Vandana Singh, Benzinga Editor
June 1, 2021 11:48 AM | 1 min read |
  • 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.
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