Seres Therapeutics Achieves Enrollment of 300 Subjects with Phase 3 ECOSPOR IV Open-Label Extension Study of SER-109, a Potentially First-in-Class Investigational Microbiome Therapeutic for Recurrent C. difficile Infection
– Seres expects both the completed Phase 3 study results and the pending open-label study database to finalize a Biologics License Application (BLA) filing in mid-2022 –
– Potential to be first-ever FDA-approved microbiome therapy –
“This is a meaningful milestone for the company as it positions us for a BLA submission that, if approved, could make SER-109 the first-ever FDA-approved microbiome therapeutic,” said
The SER-109 ECOSPOR III Phase 3 study ( ClinicalTrials.gov identifier: NCT03183128) was a multicenter, randomized, placebo-controlled study. Previously reported topline data indicated the study achieved its primary endpoint at eight weeks and demonstrated a sustained clinical response rate of approximately 88% at eight weeks post-treatment. SER-109 resulted in a 27% absolute reduction of recurrence of CDI compared to placebo at eight weeks post-treatment, which is a relative risk reduction of 68%. In May 2021, Seres presented 24-week clinical data from the study that demonstrated significantly reduced recurrence rates compared to placebo over 24 weeks (21.3% vs. 47.3%, respectively). SER-109 was observed to be well tolerated, with no treatment-related serious adverse events observed in the active arm and an adverse event profile comparable to placebo.
“SER-109 has the potential to change the treatment paradigm and meaningfully improve medical outcomes for the more than 170,000 recurrent CDI patients in the
CDI is one of the top three most urgent bacterial threats in the
Seres entered into an agreement with Nestlé Health Science in
About SER-109
SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which normally live in the healthy microbiome. SER-109 is designed to prevent further recurrences of CDI in patients with a history of multiple infections by modulating the disrupted microbiome to a state that resists C. difficile colonization and growth. The SER-109 manufacturing purification process is designed to remove unwanted microbes thereby reducing the risk of pathogen transmission beyond donor screening alone. The
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the potential approval of SER-109 and its status as a first-in-class therapeutic, the timing of a BLA filing, the ultimate safety profile of SER-109, the ultimate market for SER-109, the potential of microbiome therapeutics to treat and prevent disease, the timing and results of our clinical studies, the benefits of our collaborations, the ultimate safety and efficacy data for our products, and other statements which are not historical fact.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; the impact of the COVID-19 pandemic; our unproven approach to therapeutic intervention; the lengthy, expensive and uncertain process of clinical drug development; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; and our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the
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