FDA Approves PolyPid's Trial Design for D-PLEX

By Dean Seal

The U.S. Food and Drug Administration has agreed to PolyPid's Phase 3 trial design examining D-PLEX for the prevention of abdominal colorectal surgical site infections.

The late-stage biopharmaceutical company said Monday that the revised trial will recruit patients undergoing colorectal resection surgery with large incisions that are greater than 20 centimeters.

"We are pleased with FDA feedback to our revised protocol and are excited to resume SHIELD II trial recruitment," Chief Executive Dikla Czaczkes Akselbrad said.

Recruitment for the trial will resume imminently, PolyPid said. An estimated 550 additional patients will join the 40 who have already been recruited.

Shares jumped 18.3% to 45 cents in premarket trading.

Write to Dean Seal at [e-mail]

(END) Dow Jones Newswires

05-22-23 0939ET