PolyPid initiates late-stage study of D-PLEX100 for preventing surgical infections

• PolyPid (PYPD -2.7%) enrolls and randomizes first patient in the SHIELD I trial, the Company's first of two Phase 3 trials of lead product candidate D-PLEX₁₀₀ for the prevention of post-abdominal surgery incisional infection (soft tissue).
• The company expects to enroll 619 to 900 patients in the  study that will assess the efficacy and safety of D-PLEX₁₀₀ administered simultaneously with Standard of Care (SoC) treatment compared to a SoC-treated control arm.
• The primary endpoint is the infection rate, measured by the number of patients with at least one abdominal incisional infection event within 30 days after the surgery.
• In Phase 2 trial, D-PLEX₁₀₀ has demonstrated significant decrease in surgical site infections (SSIs) in abdominal surgery with colorectal resection.
• The company plans to launch the second Phase 3 trial for the same indication after about six months.
• D-PLEX₁₀₀ is designed for a prolonged and constant release of the broad-spectrum antibiotic doxycycline, directly at the surgical site to prevent SSIs.