PolyPid Ltd Announces New Phase 3 Shield II Data Demonstrating D-Plex100 Sustained Local Release

Published: 2026-04-13 15:06:20 ET PYPD

Published on 04/13/2026 at 03:06 pm EDT

PolyPid Ltd. announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX100 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases Global 2026, taking place on April 17-21, 2026, in Munich, Germany. The abstract titled ?Pharmacokinetics of local extended-release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,? was co-authored by Prof. Antonino Spinelli, Director of the Division of Colon and Rectal Surgery and a Professor of Surgery at Humanitas University, in Milan, Italy and PolyPid.

Sustained and controlled release profile: Detectable doxycycline concentrations were observed for up to 763 hours (approximately 32 days), with no burst, following local application of D-PLEX100 during surgery. Minimal systemic exposure: Plasma doxycycline concentrations remained below 100 ng/mL, indicating negligible systemic levels relative to oral doxycycline administration where Cmax levels are approximately 16 to 26 times higher (1,613.3 ng/mL for 100 mg and 2,600 ng/mL for 200 mg doses). ESCMID Global 2026 Presentation Details Poster Title: Pharmacokinetics of Local Extended-Release Incisional Doxycycline in Patients undergoing Abdominal Colorectal Surgery from the SHIELD II Phase 3 Clinical Trial Presenter: Eyal Shoshani, VP Clinical Affairs, PolyPid Ltd. Lead Author: Prof. Antonino Spinelli, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy Poster Details: #P2740 (Presented at: Poster Hall B3) Session: 05b.

Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring Date/Time: Sunday, April 19, 2026 | 12:00 ? 13:30 CEST The abstract will be available once the conference concludes. D-PLEX100, PolyPid?s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (?SSIs?).

Following the administration of D-PLEX100 into the surgical site, PolyPid?s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.