PolyPid: DSMB reccommends conclusion of SHIELD trial enrollment at 950 patients

PolyPid announced that following the independent Data Safety Monitoring Board 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 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 SHIELD I study is designed to demonstrate at least a 50 percent reduction in incisional SSIs in the D-PLEX100 treatment arm compared to the control arm, with 90 percent power and a maximum alpha level of 0.04. The Company anticipates reporting top-line results by the end of the third quarter of 2022, followed by a potential New Drug Application submission to the U.S. Food and Drug Administration and a European Union Marketing Authorization Application filing, both targeted for the first half of 2023. "We are pleased with the DSMB recommendation and expect to conclude the SHIELD I trial shortly," stated Amir Weisberg, PolyPid's CEO. "SSIs represent a major unmet medical need and a large commercial opportunity for D-PLEX100. We look forward to completing the SHIELD I study and advancing preparations for our planned NDA submission and pre-launch activities, while expediting partnership discussions in and outside of the United States."