- PolyPid Ltd PYPD shares lost almost 80% after announcing topline results from the SHIELD I Phase 3 study of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgery.
- D-PLEX100, compared to SoC alone, did not achieve statistical significance on the key secondary endpoint evaluating SSI events within 30 days post-abdominal index surgery.
- In the Intent to Treat (ITT) population, the local administration of D-PLEX100 and SoC (n=485) resulted in a decrease in SSIs and mortality of 23% compared to SoC alone.
- Within the first 30 days post-surgery, there were 15 deaths in the SoC arm compared to 11 in the D-PLEX100 arm.
- In a pre-specified subgroup ITT analysis requested by FDA, D-PLEX100 resulted in a statistically significant reduction of 54% on the primary endpoint compared to SoC alone.
- The SHIELD I study is designed to demonstrate at least a 50% reduction in incisional SSIs in the D-PLEX100 arm compared to the control arm.
- Within the first 30 days post-surgery, SSIs decreased from 8.5% in the SoC treatment arm to 4.2% in the D-PLEX100 treatment arm.
- The independent Data Safety Monitoring Board raised no safety concerns in SHIELD I.
- The company's second Phase 3 trial of D-PLEX100 for preventing SSIs in abdominal surgery, SHIELD II, is ongoing and has enrolled over 200 subjects.
- In May, the independent Data Safety Monitoring Board (DSMB) recommended concluding enrollment in PolyPid SHIELD I Phase 3 study of D-PLEX100.
- Price Action: PYPD shares are down 77.50% at $1.21 on the last check Friday.
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