Seres Therapeutics Completes Patient Recruitment for Phase 1B SER-155 Trial in Allogeneic Hematopoietic Stem Cell Transplant Recipients

Seres Therapeutics, a pioneering company in the field of microbiome therapeutics, has recently announced the completion of enrollment for Cohort 2 in its Phase 1b clinical trial of SER-155. This trial focuses on patients who have undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo HSCT) and is set to conclude in the third quarter of 2024. The orally administered SER-155 is a carefully selected consortium of bacteria aimed at reducing the occurrence and severity of infections stemming from the gastrointestinal tract, which are a significant cause of mortality in immunocompromised patients. The treatment also targets the induction of immune tolerance to lower the risk of Graft-versus-Host Disease (GvHD). 

Eric Shaff, CEO of Seres, expressed optimism regarding the upcoming data, which will encompass safety, pharmacology, and efficacy measurements up to day 100 post-transplantation. With approximately 40,000 Allo HSCT procedures conducted globally each year, where infection is a leading cause of death, the potential clinical outcomes could affirm the role of microbiome therapeutics in preventing adverse outcomes related to gastrointestinal pathogens. Seres plans to explore SER-155 and other therapeutic candidates in other vulnerable patient groups, such as those with chronic liver disease, cancer neutropenia, and recipients of solid organ transplants, with the vision of establishing a new standard of care to protect millions from severe infections. 

The Phase 1b study of SER-155 is being executed across 13 U.S. clinical centers and follows the completion of Cohort 1, which demonstrated favorable tolerability and significant reduction in pathogen dominance in the gastrointestinal microbiome. Cohort 2, involving 45 participants, employs a randomized, double-blind, placebo-controlled design to further assess safety, bacterial engraftment, and clinical outcomes. 

SER-155 is developed using Seres' proprietary MbTx platform technologies, which incorporate microbiome biomarker data from human clinical studies and in vivo disease models. The formulation is designed to prevent and reduce the colonization of antibiotic-resistant pathogens and to strengthen the gastrointestinal epithelial barrier, thereby reducing the risk of pathogen translocation and the incidence of bloodstream infections and GvHD. The treatment has received the FDA's Fast Track Designation. Seres Therapeutics, listed on Nasdaq as MCRB, is a commercial-stage enterprise that develops innovative microbiome therapeutics for severe diseases. Their lead product, VOWST™, received FDA approval in April 2023 as the first oral microbiome therapeutic for preventing C. difficile infection recurrence in adults and is being marketed in partnership with Nestlé Health Science. 

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