PolyPid's Lead Program Flunks Abdominal Surgery Study, Shares Tank
PolyPid Ltd (NASDAQ: 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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