- PolyPid Ltd. ( NASDAQ: PYPD ) dropped ~75% in value in the pre-market trading Friday after the Israeli company announced that its lead candidate D-PLEX100 did not meet the main goal in a Phase 3 trial for the prevention of surgical site infections ((SSIs)) in abdominal surgery.
- The SHIELD I trial was designed to evaluate the joint administration of D-PLEX100 standard of care (SoC) against SoC alone in 970 patients, out of whom 488 were part of the D-PLEX100 treatment arm and 489 were in the control arm.
- The trial did not achieve the primary endpoint of reduction in surgical site infections and mortality, the company said, noting that in the Intent to Treat (ITT) population, D-PLEX100 and SoC (n=485) led to a 23% decrease in SSIs and mortality compared to SoC alone (n=489) (p=0.1520).
For further details see:
PolyPid sheds 75% as lead candidate fails in Phase 3 trial for post-surgical infections