PolyPid Announces Publication in the American Journal of Surgery of Phase 2 Clinical Trial Post-hoc Analysis for D-PLEX₁₀₀ in the Prevention of Surgical Site Infections in Abdominal Surgery
| Source: PolyPid Ltd.
D-PLEX100 Achieved in Phase 2 Trial Significant Reduction in SSIs in Patients with Multiple Preoperative Risk Factors Versus Standard of Care
Results Consistent with SHIELD I Phase 3 Post-hoc Analysis Demonstrating Significant Primary Endpoint Reduction in Patients with One or More patient related Risk Factors
PETACH TIKVA, Israel, Jan. 03, 2023 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today 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 (SoC) in preventing superficial and deep SSIs in patients undergoing elective colorectal surgery. This post-hoc analysis was intended to evaluate the effect of D-PLEX100 on SSI incidence in patients with multiple preoperative risk factors. Thirty-day SSI rates were examined in patients in the Intention-to-treat (ITT) population and in those with two or more patient related risk factors. Individual risk factor categories included diagnoses of diabetes, chronic obstructive pulmonary disease (COPD) or a history of smoking, obesity/overweight as defined as a body mass index (BMI) of 25 or more, hypertension, and peripheral vascular disease. 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 (superficial and deep) within 30 days post-index surgery in the D-PLEX100 cohort (N=10/101 [9.9%]) compared to SoC (N=21/100 [21%]; p = 0.033). In patients with two or more risk factors, the SSI rate in the D-PLEX100 plus SOC cohort was 15.8% (6/38) compared to 37.5% (15/40) in the SOC alone cohort, demonstrating a statistically significant relative risk reduction of 58% (p = 0.042).
“The data from this post-hoc analysis are compelling, demonstrating that D-PLEX100 may be an effective addition to current SSI bundles in patients with increased risk for surgical complications, including SSI,” said Oded Zmora, M.D., colorectal surgeon, Chair of Surgery at Shamir Medical Center, Be’er Ya’akov, Israel and a co-author of this paper. “Importantly, these results are consistent with post-hoc analysis from the recently completed SHIELD I Phase 3 study, which showed that patients with one or more patient related risk factors could potentially benefit from D-PLEX100 and may help address the high unmet need in this vulnerable patient population.”