- PolyPid Ltd PYPD Shares fell nearly 80% after announcing top-line results from the Phase 3 SHIELD I study of D-PLEX100 in the prevention of postoperative site infections (SSIs) in abdominal surgery.
- D-PLEX100, compared to SoC alone, did not reach statistical significance on the key secondary endpoint assessing SSI events within 30 days after abdominal index surgery.
- In the intent-to-treat (ITT) population, local administration of D-PLEX100 and SoC (n=485) resulted in a 23% reduction in SSIs and mortality compared to SoC alone.
- Within the first 30 days after surgery, there were 15 deaths in the SoC arm compared to 11 in the D-PLEX100 arm.
- In an FDA-requested pre-specified subgroup ITT analysis, D-PLEX100 resulted in a statistically significant 54% reduction in the primary endpoint compared to SoC alone.
- The SHIELD-I study is designed to demonstrate at least a 50 percent reduction in incisional wound infections in the D-PLEX100 arm compared to the control arm.
- Within the first 30 days after 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 study of D-PLEX100 in the prevention of SSIs in abdominal surgery, SHIELD II, is ongoing and includes over 200 subjects.
- In May, the independent Data Safety Monitoring Board (DSMB) recommended final enrollment in PolyPid SHIELD I Phase 3 study of D-PLEX100.
- Price promotion: PYPD shares are down 77.50% to $1.21 on the last check Friday.
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