In The News:
– Data from SER-109 Phase 3 study in recurrent C. difficile infection expected mid-2020 –
Seres Therapeutics, Inc. announced that it will host a virtual webcast symposium focused on SER-109 as a potential new therapeutic option for recurrent Clostridioides difficile infection (CDI) on Wednesday, May 27, 2020 from 8:30 to 9:30 a.m. ET.
During the event, Mark Wilcox, M.D., Professor of Medical Microbiology, University of Leeds, and Seres’ management will discuss the CDI patient burden, the ongoing SER-109 Phase 3 ECOSPOR III study and the potential for SER-109 to become the standard of care for recurrent CDI.
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 U.S. Food and Drug Administration (FDA).
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 May 27, 2020 at 8:30 a.m. ET, including presentation slides, please visit the “Investors & Media” section of the Seres website at www.serestherapeutics.com. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 4884302. Webcast Link: https://edge.media-server.com/mmc/p/3qo4hxiv.
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.
To view press release in its entirety please click on the following link: