PolyPid decimated as Phase III trial of D-PLEX₁₀₀ misses goal

Shares of Israel-headquartered PolyPid (Nasdaq: PYPD) closed down more than 73% on Friday, and a further 9% to $1.43 in after-hours trading, as the company revealed disappointing results for its lead drug candidate.

PolyPid said that D-PLEX100, its formulation of the broad-spectrum antibiotic doxycycline for the prevention of surgical-site infections (SSIs), failed to meet the primary endpoint of a Phase III study.

SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX100) is a prospective, multinational, randomized, double-blind Phase III trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC) compared to a SoC alone arm, in the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the combination of incisional SSIs and mortality as measured by the proportion of subjects with either an SSI event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The SHIELD I study is designed to demonstrate at least a 50% reduction in incisional SSIs in the D-PLEX100 treatment arm compared to the control arm, with 90% power and a maximum alpha level of 0.0487.