(RTTNews) - Seres Therapeutics, Inc. (MCRB), a commercial-stage company developing novel microbiome therapeutics for serious diseases, on Thursday announced promising new translational biomarker results from its SER-155 Phase 1b clinical study in patients undergoing allogeneic hematopoietic stem cell transplantation or allo-HSCT.
The SER-155 Phase 1b study included two cohorts:
Cohort 1 was designed to assess safety and drug pharmacology, specifically the drug strain engraftment in the gastrointestinal tract.
Cohort 1 included 13 subjects who received any dosing of the SER-155 regimen, with 11 subjects subsequently receiving an allo-HSCT.
Cohort 2 uses a randomized, double-blind, 1:1 placebo-controlled design with 45 patients to assess safety, drug strain engraftment, and secondary endpoints like bacterial bloodstream infections, febrile neutropenia, and antibiotic use.
The company's findings also reinforce the broader potential of SER-155 and its live biotherapeutic platform to treat inflammatory and immune diseases, such as inflammatory bowel disease or IBD.
Additionally, SER-155's Phase 1b clinical data have been accepted for an oral presentation at the 2025 TANDEM Meeting.
Seres has received FDA Breakthrough Therapy designation for SER-155 and expects to engage with the agency later this quarter. The company's cash runway extends into first quarter 2026, supported by expected payments from the VOWST sale to Nestlé Health Science.
Seres continues to explore SER-155's potential across multiple disease areas and is actively seeking external partnerships to further develop its live biotherapeutic candidates.
The company had $66.8 million in cash and cash equivalents, as of September 30, 2024.
MCRB shares began trading on the Nasdaq Global Select Market on June 26, 2015 under the ticker symbol "MCRB", priced at $18 per share.
MCRB closed Wednesday's (January 08, 2025) trading at $0.85, down 2.30%. In after-hours trading, the stock was at $0.85.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
