- The independent Data Safety Monitoring Board (DSMB) has recommended concluding enrollment in PolyPid Ltd's (NASDAQ:PYPD) SHIELD I Phase 3 study of D-PLEX100 to prevent surgical site infections (SSIs) abdominal tissue surgery.
- DSMB recommended stopping enrollment upon 950 patients, which is the minimum number of targeted patients in the study protocol
- The suggestion follows the DSMB review of unblinded efficacy data from the first 750 enrolled patients.
- The SHIELD I study is designed to demonstrate at least a 50% reduction in incisional SSIs in the D-PLEX100 treatment arm compared to the control arm.
- The company anticipates reporting topline results by the end of Q3 of 2022, followed by potential US and European marketing applications targeted for 1H of 2023.
- D-PLEX100, PolyPid's lead product candidate, is designed to provide local prolonged, and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
- Price Action: PYPD shares are up 1.43% at $4.98 during the market session on the last check Monday.
