PolyPid's D-PLEX100 Study Meets Primary, Key Secondary Efficacy Endpoints; Stock Rises

(RTTNews) - PolyPid Ltd. (PYPD), Monday announced topline results from its pivotal SHIELD II Phase 3 trial of D-PLEX100, achieving primary and key secondary efficacy endpoints and showing statistically significant results.

The trial for the prevention of surgical site infections or SSI in patients undergoing abdominal colorectal surgery with large incisions showed 58 percent reduction in SSI rates.

Additionally, a 62 percent reduction of patients with over 20 ASEPSIS score, a clinical tool used to objectively assess surgical wound infections, was noted in D-PLEX100 plus standard of care or SoC arm compared to SoC alone arm.

Also, no safety concerns were raised by the independent Data Safety Monitoring Board in SHIELD II.

Based on these findings, the company expects to submit a New Drug Application to the U.S. Food and Drug Administration in early 2026, with a Marketing Authorization Application in the E.U. soon after that.

Currently, PYPD is trading at $3.64, up 11.31 percent on the Nasdaq.