PolyPid to Showcase 64% SSI Reduction in Phase 3 SHIELD II Trial
PolyPid’s Phase 3 SHIELD II trial of D-PLEX 100 showed a 64% relative risk reduction (p=0.0103) in clinically significant surgical wound infections (ASEPSIS score>20) following abdominal colorectal surgery. Presentation at the Surgical Infection Society Annual Meeting highlights reduced infection severity and potential to cut hospital resource use.
1. Phase 3 SHIELD II Trial Results
PolyPid’s Phase 3 SHIELD II trial evaluated D-PLEX 100 plus standard care versus standard care alone in abdominal colorectal surgery. The analysis revealed a 64% relative risk reduction (p=0.0103) in patients with an ASEPSIS score above 20, indicating significantly fewer severe wound infections.
2. Clinical Implications and Resource Utilization
Data demonstrate not only fewer surgical site infections but also reduced infection severity among breakthrough cases. These improvements may translate into fewer wound complications, reduced intravenous antibiotic use, earlier discharge, and decreased physician and nursing resource demands.
3. Presentation at Surgical Infection Society 2026
Dr. Robert G. Sawyer will present the detailed ASEPSIS score analysis at the 45th Annual Meeting of the Surgical Infection Society on May 6, 2026 in Coronado, California. The session will outline secondary endpoint results and discuss implications for postoperative care.
4. About D-PLEX 100 and PolyPid
D-PLEX 100 uses PolyPid’s Kynatrix delivery technology to release doxycycline locally over 30 days, targeting surgical site infections including antibiotic-resistant strains. The product holds FDA Breakthrough Therapy designation for elective colorectal surgery and met all key endpoints in SHIELD II.