eight weeks following administration of SER-109 or placebo. As a secondary endpoint, patients are evaluated for CDI recurrence through 24 weeks post-treatment, and we plan to present those results at a future date.
SER-109 met the study’s primary endpoint with a significantly lower recurrence rate of 11.1% in SER-109 patients versus 41.3% in placebo patients at 8 weeks (p<0.001). Patients administered SER-109 experienced a 30.2% lower rate of recurrence, on an absolute basis, compared to placebo. The SER-109 treatment arm relative risk was 0.27 (95% CI=0.15 to 0.51) versus placebo. The ECOSPOR III recurrence rates translate into a sustained clinical response rate of 88.9% versus 58.7% with SER-109 and placebo, respectively. The SER-109 Number Needed to Treat was approximately 3.
In prior discussions, the FDA communicated that demonstration of a statistically very persuasive efficacy finding in the ECOSPOR III primary endpoint, defined as demonstrating a 95% upper confidence level of relative risk lower than 0.833, could support a BLA submission on the basis of this single study. The results of ECOSPOR III demonstrated a SER-109 relative risk of 0.27 (95% CI=0.15 to 0.51) compared to placebo. As a result, we believe that this study should support the efficacy basis for a BLA submission. SER-109 has obtained FDA Breakthrough Drug and Orphan Drug Designations.
SER-109 was well-tolerated, with no treatment-related serious adverse events observed in the active arm, and an adverse event, or AE, profile similar to placebo. The overall incidence of patients who experienced AEs during the 8-week study period was similar between SER-109 and placebo arms. The most commonly observed treatment-related AEs were flatulence, abdominal distention, and abdominal pain, which were generally mild to moderate in nature, and these were observed at a similar rate in both the SER-109 and placebo arms.
A SER-109 open-label study is ongoing at selected clinical sites that participated in the ECOSPOR III study and we may initiate the program at additional clinical sites. The FDA has previously indicated that SER-109 administration to at least 300 patients, consistent with standard FDA guidance, would be required to support a BLA submission. The ongoing SER-109 open label study is continuing to contribute to the SER-109 safety database.
We plan to immediately request a Breakthrough Therapy Designation meeting with the FDA to discuss the requirements to submit a BLA seeking regulatory approval of SER-109. As of August 10, 2020, we have a safety database with the SER-109 Phase 3 dose of approximately 105 subjects. We anticipate adding additional subjects in the open label portion of the study and we expect to include data from these subjects in the safety data portion of the BLA. Subject to discussions with the FDA, we expect to submit a BLA next year. We believe that enrollment in the open label portion of the study going forward will accelerate given the strength of the Phase 3 data, and the limited availability of alternative treatment options. We plan to discuss with the FDA at our upcoming Breakthrough Therapy Designation meeting whether any additional safety data may be required in the context of the favorable safety profile we have observed in clinical studies. Based on what we learn in this meeting, we will further refine our anticipated timing for a BLA filing.
Concurrent Placement
On August 12, 2020, we entered into a Securities Purchase Agreement with Nestlé for the sale of 959,002 shares of our common stock, at a sale price per share equal to $20.855 in the concurrent placement. The consummation of the concurrent placement is contingent upon the closing of this offering, and the satisfaction of certain other customary conditions. However, the consummation of this offering is not contingent on the consummation of the concurrent placement. The concurrent placement may have two closings, the first of which may occur on or within two business days of the closing of this offering for a number of shares equal to the maximum number (not to exceed $16.0 million of shares) of shares that Nestlé may purchase without HSR clearance. A second closing for the remaining shares will occur following, and subject to, HSR clearance. Contingent on the requirement for HSR clearance, all 959,002 shares may be sold in one of these closings.
Corporate Information
We were incorporated in the State of Delaware in 2010 under the name Newco LS21, Inc. In October 2011, we changed our name to Seres Health, Inc., and in May 2015, we changed our name to Seres Therapeutics, Inc. Our principal executive offices are located at 200 Sidney Street, Cambridge, Massachusetts 02139 and our telephone number is (617) 945-9626. Our website address is www.serestherapeutics.com. The information contained in, or accessible through, our website does not constitute a part of this prospectus supplement.