PolyPid Announces Recommendation by Data Safety Monitoring Board to Conclude Enrollment of Phase 3 SHIELD I Trial of D-PLEX₁₀₀ at the Minimum Number of Patients Targeted Following Unblinded Interim Efficacy Analysis
PETACH TIKVA, Israel, May 23, 2022 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, announced today that following the independent Data Safety Monitoring Board (DSMB) review of unblinded efficacy data from the first 750 enrolled patients in the SHIELD I Phase 3 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal tissue surgery, the recommendation was to conclude the study upon enrollment of 950 patients, which is the minimum number of targeted patients in the study protocol. The enrollment of the 950th patient is expected to occur within days.
- The trial has enrolled patients in more than 60 centers inthe United States,EuropeandIsrael.
- D-PLEX100, PolyPids lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
- D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery.
- This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act and other securities laws.