By Mary de Wet


PolyPid said Tuesday that it has produced three process-validation batches of D-PLEX, its lead drug candidate to prevent surgical-site infections, putting the company on track to seek regulatory approval.

The Israel-based biopharma company didn't give a timeline for when it would submit new drug and marketing authorization applications for D-PLEX to the U.S. Food and Drug Administration.

"The successful validation of the production process at commercial scale is the result of a significant facility expansion and scale-up that more than tripled the Company's capacity to manufacture D-PLEX(100) for the U.S., EU and global markets," Chief Executive Dikla Czaczkes Akselbrad said.

PolyPid is testing D-PLEX in a Phase 3 trial to prevent infections in patients undergoing open abdominal colorectal surgery with large incisions. Top-line results are expected in mid-2024.


Write to Mary de Wet at mary.dewet@dowjones.com


(END) Dow Jones Newswires

09-19-23 0752ET