Feb. 10 at 11:09 PM
$PYPD PolyPid’s first Phase 3 trial (SHIELD I) for its surgical site infection candidate, D-PLEX100, failed to meet its primary endpoint in September 2022 primarily due to a lower-than-expected infection rate in the control group, which was heavily influenced by COVID-19 safety protocols.
Key Reasons for Failure:
Low Infection Rate in Control Arm: The study, which focused on abdominal surgeries, found that the Standard of Care (SoC) arm had a surgical site infection (SSI) rate of only 6.3%. This was significantly lower than the anticipated "mid-teens" percentage expected based on historical data for such surgeries.
Impact of COVID-19 Protocols: The reduced infection rate was linked to safety measures implemented during the COVID-19 pandemic, such as enhanced hygiene, social distancing, and changes in surgical procedures, which lowered the overall, baseline risk of infection in both groups.
Insufficient Statistical Power:
