PYPD - PolyPid launches second late-stage trial with D-PLEX100 in surgical infections
PolyPid ([[PYPD]] -5.5%) has enrolled and randomized the first patient in the company's second Phase 3 trial, SHIELD II, evaluating its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue).Enrollment in first Phase 3 clinical trial, SHIELD I, continues to progress, and topline data is anticipated in 2H of next year.This second Phase 3 study is designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with the Standard of Care (SoC), compared to SoC, for the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the infection rate within 30 days post-abdominal surgery.In November, the lead candidate received Breakthrough Therapy status from the FDA.
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PolyPid launches second late-stage trial with D-PLEX100 in surgical infections