Seres Therapeutics is to receive up to $3.6m in further non-dilutive funding from the international non-profit partnership, Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), to develop and produce an oral liquid version of SER-155.
The therapy is intended for individuals at heightened risk of bloodstream infections (BSIs), including those with antimicrobial-resistant (AMR) infections who are unable to take oral capsules, such as intubated intensive care unit (ICU) patients.
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In 2024, SER-155 received breakthrough therapy status from the US Food and Drug Administration (FDA) for decreasing BSIs in the adult population.
It is under development for individuals undergoing allogeneic haematopoietic stem cell transplants (allo-HSCT). This group is particularly vulnerable to severe infections due to extended immunosuppression.
In a placebo-controlled, randomised Phase Ib trial, the therapy demonstrated a 77% reduction in bacterial BSIs against placebo.
The study also noted reductions in the use of systemic antibiotics and occurrences of febrile neutropenia.
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By GlobalDataThe company has obtained positive feedback from the FDA regarding the protocol of a forthcoming placebo-controlled Phase II trial.
Seres Therapeutics chief scientific officer Matthew Henn stated: “We have been encouraged by the compelling SER-155 clinical data to date, including data showing the potential of SER-155 to reduce the frequency of BSIs and also lessen reliance on antibiotics in allo-HSCT patients.
“Developing a liquid formulation will improve accessibility for patients who cannot take capsules, such as those in intensive care, providing an opportunity to potentially broaden impact of the programme in additional patient populations at high risk of BSIs and AMR infections.”
Seres developed VOWST, an oral microbiome therapy that is approved by the US regulator. It was sold to Nestlé Health Science in September 2024.
Unlike VOWST’s donor-based production method, SER-155 and other pipeline programmes of the company utilise manufacturing from standard clonal cell banks through cultivation processes.
Seres plans to assess SER-155 and additional cultivated live biotherapeutic candidates in medically vulnerable groups such as autologous-HSCT subjects, people with chronic liver disease and cancer subjects with neutropenia.
