PolyPid Ltd. 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. 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 discussion with the FDA and the EU regulatory authorities. D-PLEX100, PolyPid's lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.

Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.