PolyPid Ltd.’s Phase III SHIELD I trial of D-PLEX100 for preventing surgical site infections (SSIs) among patients receiving abdominal surgery failed to be the successful trial that analysts had thought it would be. However, better-than-expected performance in the control arm due to COVID-19 restrictions appears to have played a role, and the trial did meet its primary endpoint in a subgroup analysis, meaning the drug may have a future yet.
The Israeli biotech announced topline results from the 977-patient study on 2 September, showing that in the intent-to-treat (ITT) analysis, it did not meet its primary endpoint of showing a statistically significant decrease in SSIs and mortality for patients receiving D-PLEX100 plus standard-of-care treatment versus the standard of care alone
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