Seres Therapeutics Advances SER-155 Development with FDA Guidance
Seres Therapeutics Moves Forward with SER-155 Development
The recent engagement between Seres Therapeutics, Inc. and the U.S. Food and Drug Administration (FDA) marks a significant milestone in the clinical development of SER-155, an innovative live biotherapeutic aimed at improving patient outcomes undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT). The FDA has shared constructive feedback regarding the clinical development plans, particularly supporting the proposed primary efficacy endpoint focused on reducing bloodstream infections within 30 days post-transplant.
Key Insights from FDA Feedback
The guidance received includes a recommendation to conduct the next study as a Phase 2 trial, emphasizing the importance of measuring the reduction in bloodstream infections as a core objective. This endorsement reinforces the strategic direction of Seres as it navigates the complex regulatory landscape, underlining the relevance of SER-155 for patients who are particularly vulnerable during the post-transplant period.
Expected Protocol Submission
In light of the FDA’s feedback, Seres is actively fine-tuning the study design for SER-155, considering both a Phase 2 and a Phase 2/3 approach that could enhance operational efficiencies. The Company plans to submit the revised protocol to the FDA, which will incorporate the agency's insights, anticipated in the upcoming months. This careful approach reflects the Company’s commitment to aligning closely with regulatory guidance as they advance their critical research.
Commitment to Patient Needs
Eric Shaff, President and CEO of Seres Therapeutics, expressed optimism about the constructive engagement with the FDA. He emphasized the importance of this input in effectively navigating the development road ahead, which is essential for getting SER-155 to patients who need it most. The feedback received has set the stage for a protocol submission expected in the upcoming quarter. Seres remains dedicated to ensuring that the study design incorporates previous positive outcomes observed in earlier trials, particularly the notable relative risk reduction in bloodstream infections.
Clinical Trial Successes
SER-155 has previously demonstrated remarkable results in a Phase 1b placebo-controlled trial, showing a 77% reduction in bloodstream infections and decreasing the need for systemic antibiotics. These promising results underline the potential impact of SER-155 in preventing infections related to allo-HSCT, a critical factor in the recovery of patients undergoing this challenging procedure.
About SER-155
SER-155 is an oral live biotherapeutic specifically designed to combat gastrointestinal pathogens, bolster epithelial barrier function, and promote immune tolerance. Its primary goal is to mitigate the risk of bacterial infections and complications associated with allo-HSCT procedures. With Breakthrough Therapy and Fast Track designations from the FDA, SER-155 aims to significantly improve health outcomes for patients afflicted with hematologic malignancies.
About Seres Therapeutics
Seres Therapeutics, Inc. is a pioneering clinical-stage company dedicated to enhancing patient outcomes in medically vulnerable populations through pioneering live biotherapeutics. The Company’s recent success includes the development of VOWST™, recognized as the first FDA-approved oral microbiome therapeutic, significantly impacting the treatment landscape. Seres remains committed to exploring SER-155 for various patient demographics, including those undergoing autologous-HSCT, cancer patients facing neutropenia, CAR-T recipients, and other vulnerable groups.
Frequently Asked Questions
What is SER-155?
SER-155 is an investigational live biotherapeutic intended to improve outcomes by preventing infections during allo-HSCT.
What feedback did Seres Therapeutics receive from the FDA?
The FDA supported the proposed primary efficacy endpoint and recommended a Phase 2 study focusing on bloodstream infection reduction.
When does Seres plan to submit the new protocol to the FDA?
The submission for the revised protocol is planned for the upcoming quarter, aligning with FDA feedback.
What were the results of the previous Phase 1b trial for SER-155?
The trial indicated a 77% relative risk reduction in bloodstream infections, showcasing the potential effectiveness of SER-155.
How does SER-155 work?
SER-155 targets gut pathogens to enhance immune response and prevent complications in patients receiving allo-HSCT.
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