Business
PolyPid Provides Corporate Update and Reports Second Quarter 2023 Financial Results
Reached Agreement with U.S. FDA on Design of SHIELD II Phase 3 Trial Evaluating D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site Infections
About this update from Polypid Ltd.
[{"type":"text","content":"Reached Agreement with U.S. FDA on Design of SHIELD II Phase 3 Trial Evaluating D-PLEX100 for the Prevention of Abdominal Colorectal Surgical Site Infections Resumed Recruitment into SHIELD II Phase 3 Trial in Late June 2023 Total of 20 centers in U.S., Europe and Israel Expected to be Opened by End of Current Quarter Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Aug. 09, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three and six months ended June 30, 2023. Recent Corporate Highlights: Reached agreement with U.S. Food and Drug Administration (“FDA”) on the design of the SHIELD II Phase 3 trial. The revised SHIELD II trial is recruiting patients undergoing open colorectal abdominal surgery with large incisions. Resumed recruitment in late June 2023 with a total of 40 patients already recruited into SHIELD II trial.Regulatory authorities in multiple countries have now approved the trial protocol and PolyPid expects to have 20 centers open in U.S., Europe and Israel by the end of the current quarter.Unblinded interim analysis is planned to be conducted once approximately 400 patients complete their 30-day follow-up.Total recruitment time into the trial is anticipated to be approximately 12 months and top-line results are expected in mid-2024. Published a paper highlighting the potent antibacterial activity of D-PLEX100 and its potential as an effective prophylactic drug against the most prevalent bacteria causing surgical site infections (“SSIs”), including resistant strains, in the European Journal of Pharmaceutical Sciences. “Following our agreement with the FDA on the design of the SHIELD II Phase 3 trial and the subsequent resumption of the trial, our promising lead product candidate, D-PLEX100, is advancing as planned in the clinic,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “As we expect to have 20 centers open by the end of the current quarter, we anticipate that the rate of enrollment will increase rapidly.” “Moreover, we are beginning to see the impact of our cost containment efforts,” continued Ms. Czaczkes Akselbrad. “Despite a challenging inflationary environment, we have generated over $1 mil...