Seres Therapeutics to Host Virtual SER-109 Focused Symposium on May 27, 2020, Ahead of Phase 3 ECOSPOR III Study Read-Out
– Data from SER-109 Phase 3 study in recurrent C. difficile infection expected mid-2020 –
During the event,
SER-109 is being evaluated in an ongoing Phase 3 study for the prevention of recurrence of CDI. SER-109 has obtained both Breakthrough Therapy Designation and Orphan Drug Designation from the
Seres previously reported the completion of enrollment in the Phase 3 ECOSPOR III study (ClinicalTrials.gov identifier: NCT03183128), a multicenter, randomized 1:1, placebo-controlled study in patients with multiply recurrent CDI. ECOSPOR III has enrolled 182 patients. Seres expects to report SER-109 Phase 3 top-line results in mid-2020.
Based on prior discussions with the FDA, Seres believes that ECOSPOR III has the potential to be the single pivotal study supporting product registration; however, this will depend on the strength of the data, and additional safety data may be required. If approved, SER-109 has the potential to be the first FDA-approved therapy for CDI to treat the underlying cause of this disease, and the first approved microbiome drug for any human condition.
To join the live webcast, on
A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for approximately 21 days.
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 timing and results of our clinical studies, the potential for ECOSPOR III to serve as a pivotal trial to enable a BLA submission, the potential impact of SER-109 and other statements that are not historical facts.
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; 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; the impact of the COVID-19 pandemic; our ability to retain key personnel and to manage our growth; and our management and principal stockholders have the ability to control or significantly influence our business. 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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