Business
PolyPid Ltd. Provides Corporate Update and Reports Third Quarter 2020 Financial Results
• Over 50% of planned 60 centers for ongoing Phase 3 SHIELD I trial of D-PLEX100 in abdominal surgery have received IRB approval • Phase 3 SHIELD II trial
About this update from Polypid Ltd.
[{"type":"text","content":"• Over 50% of planned 60 centers for ongoing Phase 3 SHIELD I trial of D-PLEX100 in abdominal surgery have received IRB approval \n • Phase 3 SHIELD II trial advanced; preparations underway to initiate by year-end 2020 • Conference Call Scheduled for today at 8:30 a.m. ET PETAH TIKVA, Israel, Nov. 11, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (the “Company”), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2020. Recent Corporate Highlights: Over 50% of planned 60 centers have received institutional review board (IRB) approval for ongoing Phase 3 SHIELD I (Surgical site Hospital-acquired Infection PrEvention with Local D-plex) trial for D-PLEX100 in abdominal surgery (soft tissue). This is the first of two planned Phase 3 clinical trials of D-PLEX100, the Company’s lead product candidate for the prevention of surgical site infections (SSIs) in abdominal surgery (soft tissue). The Company plans to enroll 600 - 900 patients undergoing high priority operations in 60 centers in the United States, Europe, and Israel. Following the enrollment of approximately 500 patients, the study design provides for a blinded sample size re-estimation.Advanced preparations are underway to initiate SHIELD II, a second Phase 3 trial for D-PLEX100 in abdominal surgery, by year-end 2020. This second trial will have broader eligibility criteria, including minimally invasive surgical procedures, and will enroll approximately 900 - 1,400 patients across approximately 60 centers. Evaluating EU commercial partnership opportunities for D-PLEX100 as part of the Company’s stated commercial strategy. “We are very encouraged with our strong progress to date, especially readying additional sites to enroll patients in our lead Phase 3 trial, and remain on track for our planned milestones,” said Amir Weisberg, Chief Executive Officer. “We continue to anticipate that top-line results from SHIELD I will be available in the second half of 2021. Moreover, we expect that the initiation of our second Phase 3 pivotal trial, SHIELD II, will occur in late 2020. SHIELD I and SHIELD II will serve as the basis for PolyPid’s fi...