PolyPid has completed patient enrollment of 200 patients in its Phase 2 clinical trial evaluating D-PLEX100 for the prevention of post-abdominal surgery incisional site infections.
PolyPid previously reported that the trial was planned to enroll up to 300 patients undergoing elective colorectal surgery. The Phase 2 trial design included a pre-planned blinded sample size re-estimation. When the re-estimation was conducted, it indicated that the trial can be completed after enrollment of only 200 patients.
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The Phase 2 clinical trial, initiated on October 2018, is a prospective, multicenter, randomized, controlled, single-blind, two arm study to assess the safety and efficacy of D-PLEX100 administered concomitantly with the Standard of Care (SOC), compared to SOC treated control arm, in the prevention of post-abdominal surgery incisional infection (superficial and deep) over a period of 30 days.
"Abdominal surgeries, and especially those involving colorectal resection, are known to be associated with the highest rate of surgical site infections (SSI) among all elective surgical procedures," said Amir Weisberg, PolyPid's CEO. "We believe that D-PLEX100 has the potential to radically transform the prevention of SSIs, and we look forward to reporting top-line data from this study by the end of October 2019."
PolyPid's lead drug product candidate, D-PLEX100, is a novel product designed to provide local and prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables the prolonged and constant release of broad-spectrum antibiotic that generates high local concentration of the antibiotics for a period of four weeks, thus allowing effective prevention of infection after surgery with increased potential to eradicate antibiotic resistant bacteria. D-PLEX100 has received two QIDP designations from the FDA for the prevention of sternal wound infection post cardiac surgery and for the prevention of post-abdominal surgery incisional infection.