PolyPid Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results for D-PLEX100 in the Prevention of Surgical Site Infections in Abdominal Surgery
Intends to discuss the Clinical Outcomes and Next Steps for D-PLEX100 for the Prevention of SSIs in Abdominal Surgery with the FDA and the EU Regulatory Authorities in Q1 2023
PETACH TIKVA, Israel, Sept. 19, 2022 (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 positive clinical data from the previously completed Phase 2 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. The paper, entitled, “A prospective, randomized assessment of a novel, local antibiotic releasing platform for the prevention of superficial and deep surgical site infections,” was published in Techniques in Coloproctology, 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. Efficacy was measured by the incidence of SSIs and mortality within 30 days post-surgery. SSIs were adjudicated by the endpoint adjudication committee, all of whom were blinded to study-group assignments. In addition, safety was assessed by the stratification and incidence of treatment-emergent adverse events.
One hundred and seventy-nine patients were evaluated in the per protocol population, 88 in the intervention arm [51 males, 37 females, median age 64.0 (range: 19–92) years] and 91 in the control arm [57 males, 34 females, median age 64.5 (range: 21–88) years]. The SSI rate (superficial and deep) within 30 day post-index surgery showed a 64% statistically significant relative risk reduction in the D-PLEX100 plus SoC cohort at 8% infection rate [n=7/88] compared to 22% infection rate in the SoC alone cohort [n=20/91] (p=0.0115). There was no statistically significant difference in the incidence of treatment-emergent adverse events (TEAEs) between the two groups, and no difference in severity and incidence of serious TEAEs. No TEAEs in the D-PLEX100 plus SoC cohort were deemed related to the study drug.
“We are pleased by the publication of the positive results from our Phase 2 study of D-PLEX100,” said Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “The results of this trial were the basis of the Breakthrough Therapy Designation for D-PLEX100 granted by the U.S. Food and Drug Administration (FDA) and a precursor to the Company’s SHIELD I Phase 3 trial that concluded earlier this month. PolyPid is further evaluating the collective results of SHIELD I and the Phase 2 study, and intends to discuss the clinical outcomes and next steps for D-PLEX100 for the prevention of SSIs in abdominal surgery with the FDA as well as the EU (European Union) regulatory authorities in Q1 2023.”
The appropriate next steps for PolyPid’s second Phase 3 trial of D-PLEX100 for the prevention of SSIs in abdominal surgery, SHIELD II, which incorporates broader eligibility criteria and has enrolled over 200 subjects to date, will be evaluated following the discusson with the FDA and the EU regulatory authorities.
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