PolyPid announces enrollment in 200th patient in SHIELD II Phase 3 trial

PolyPid announced that it has enrolled the 200th patient in its ongoing SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. The study is now approximately one-third enrolled and is anticipated to continue enrollment at a pace of 1.5 patients per center per month. “Enrollment into SHIELD II has significantly ramped-up during the last two months and is now progressing at a consistently robust pace,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “We continue to expect top-line results from SHIELD II in the second half of 2024. Importantly, the $16 million financing we successfully completed earlier this year extends our cash runway beyond the anticipated timing of the study’s planned unblinded interim analysis, and we have the potential to secure an additional $19 million if the results of the unblinded interim analysis are positive and warrants are exercised, which would fund the Company to the start of a planned rolling New Drug Application (“NDA”) submission for D-PLEX100.”