Published on 23 May 2022 on Benzinga via Yahoo Finance
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 protocolThe 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.
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