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PolyPid’s D-PLEX100 May Have Way Forward Despite Phase III Miss

 
• By Alaric DeArment

The SHIELD I trial, for preventing surgical site infections, did not meet its primary and key secondary endpoints, but a subgroup analysis did, while COVID-19 may have muddled results.

PolyPid announced results from the Phase III study of D-PLEX100 in preventing surgical site infections • Source: Shutterstock

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...

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