Seres Therapeutics announced that the FDA granted Breakthrough Therapy designation to SER-155, their lead investigational drug, for reducing bloodstream infections in adults undergoing stem cell transplants.
This designation is based on positive Phase 1b clinical trial data showing a significant reduction in infections compared to a placebo.
A meeting with the FDA to discuss the next clinical study is planned for Q1 2025.
Seres is also seeking a strategic partnership to accelerate development and expand SER-155’s use to other patient populations.
The drug is an oral live biotherapeutic designed to address a significant unmet need in this high-risk patient group.
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