PolyPid announced the peer-reviewed publication of a post-hoc analysis from the previously-completed Phase 2 study of D-PLEX100 for the prevention of surgical site infections, SSIs, in abdominal surgery. The paper, entitled, "Reduction in Surgical Site Infections by Localized Administration with D-PLEX100 in Patients with Multiple Risk Factors Undergoing Colorectal Surgery," was published in the American Journal of Surgery and can be found here. The Phase 2 trial was a prospective, multicenter, randomized, controlled, single-blind, two arm study and was designed to assess the efficacy and the safety of D-PLEX100 in addition to standard of care in preventing superficial and deep SSIs in patients undergoing elective colorectal surgery. Thirty-day SSI rates were examined in patients in the Intention-to-treat population and in those with two or more patient related risk factors. The distribution of the assessed risk factors between the D-PLEX100 plus SoC and SoC cohorts was approximately even. Two hundred and one patients were evaluated in the ITT population, 101 in the intervention arm and 100 in the control arm. The study showed a 53% statistically significant relative risk reduction of the SSI rate within 30 days post-index surgery in the D-PLEX100 cohort compared to SoC. In patients with two or more risk factors, the SSI rate in the D-PLEX100 plus SOC cohort was 15.8% compared to 37.5% in the SOC alone cohort, demonstrating a statistically significant relative risk reduction of 58%.
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