Polypid Ltd. · NASDAQ:PYPD
Polypid — Surgical Infection Society 45th Annual Meeting (SIS 2026)
10 slides from Polypid's conference presentation, May 2026
Slide 1: Evaluation of ASEPSIS Score as a Secondary Endpoint in the Phase 3 SHIELD II Trial
Evaluation of ASEPSIS Score as a Secondary Endpoint in the Phase 3 SHIELD II Trial of D-PLEX100 in Colorectal Surgery Robert G. Sawyer, MD, FSIS, FACS, FCCM, FIDSA Professor, Department of Surgical Sciences Western Michigan University Homer Stryker M.D. School of Medicine Surgical Infection Society
Slide 2: Disclosures
Disclosures In the past three years I have consulted for Molnlycke, Shionogi, and PolyPid D-PLEX100 is under FDA review and has not yet obtained marketing authorization
Slide 3: Agenda
Agenda 1. D-PLEX100 : Mechanism of action and therapeutic rationale 2. SHIELD II trial design and methodology 3. Primary endpoint and safety profile 4. Secondary endpoint: Evaluation of ASEPSIS score performance 5. Conclusion and clinical implications
Slide 4: D-PLEX100: A high-concentration doxycycline formulation delivered locally over 30 days
D-PLEX100: A high-concentration doxycycline formulation delivered locally over 30 days Developed for prevention of surgical site infections (SSIs) following abdominal colorectal surgery • Applied as a single dose paste to the surgical site prior to incision closure • Designed to provide localized, s
Slide 5: SHIELD II: Phase 3 randomized controlled double-blind trial design
SHIELD II: A Phase 3, prospective, multinational, randomized, controlled double-blind trial evaluating the safety and efficacy of D-PLEX100 in the prevention of incision infection post abdominal surgery Patient Population Primary efficacy endpoint Safety assessment • Patients undergoing elective abd
Slide 6: SHIELD II: Primary and Key Secondary Results
SHIELD II: Primary and Key Secondary Results Primary Efficacy Endpoint Key Secondary Endpoint: (ITT cohort) SSI reduction (ITT Cohort) 71 60% (18.1%) 40% reduction reduction 36 (9.5%) (p=0.0013) (p=0.0039) 43 (10.9%) 14 (3.8%) SoC* D-PLEX100 + SOC SoC* D-PLEX100 + SOC n=393 n=405 n=377 n=391 Standar
Slide 7: ASEPSIS Score: What is it and How is it Calculated?
ASEPSIS Score: What is it and How is it Calculated? A customized adaptation of the validated ASEPSIS Score to measure the impact of D-PLEX100 on wound appearance and severity of SSI in the abdominal wall Wound was evaluated and scored at each study patient visit (days 1, 2, 3, 5, 14, 30, 60) Proport
Slide 8: Key Secondary Endpoint: ASEPSIS Score >20
Key Secondary Endpoint: ASEPSIS Score > 20 Number of patients with ASEPSIS Score >20 (ITT Cohort) • D-PLEX100 showed statistically 64% significant reduction in the number of 21 reduction sever infections (p=0.0103) (5.6%) • Can potentially have impact on: • Recovery and wound healing time 8 (2.0%) •
Slide 9: Highest ASEPSIS Score per Subject is score >20
Highest AEPSIS Score per Subject is score >20 cm D-PLEX + SoC (n=15) SoC (n=27) 48 42 41 36 36 37 35 3535 33 34 33 30 30 30 29 28 26 25 24 26 24 25 24 25 25 23 23 2222 2424 25 25 22 22 21 22 22 21 21 21 Subject Subject
Slide 10: Conclusions
Conclusions • D-PLEX100 + SoC resulted in improved outcomes for abdominal colorectal surgery patients • Lower rates of wound complications by ASEPSIS criteria, including fewer patients with scores >20 • Findings support the potential role of D-PLEX100 at the prevention of SSI in colorectal surgery •
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