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PolyPid's Single Pivotal Study Sufficient To Support Potential Approval Of D-PLEX100 For Infections After Colorectal Surgery

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  • PolyPid Ltd (NASDAQ: PYPD) has received written responses from the FDA to a Type B meeting request that the company submitted regarding its development plan for its lead candidate, D-PLEX100.

  • The FDA indicated that PolyPid's proposal for a single Phase 3 pivotal study (SHIELD I) would be sufficient to establish clinical efficacy and safety to support approval of D-PLEX100 for the prevention of surgical site infections (SSIs) in colorectal surgery.

  • To date, over 200 patients are enrolled, and the topline data is expected by the end of 2021.

  • The trial's primary endpoint is the combination of incisional SSIs and mortality rate within 30 days post-surgery.

  • The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients.

  • Price Action: PYPD shares are up 0.98% at $9.29 on the last check Wednesday.

  • Related content: Benzinga's Full FDA Calendar

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