PolyPid Begins Phase 2 Study to Assess Safety and Efficacy of D-PLEX100 in Prevention of Abdominal Surgical Site Infections
- Category: Small Molecules
- Published on Tuesday, 16 October 2018 08:20
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Study to enroll up to 300 patients; with top-line results expected in the second half of 2019
PETAH TIKVA, Israel I October 15, 2018 I PolyPid Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing new innovative therapies for post-surgical complications, announced today that the first patient has been enrolled in a Phase 2 clinical study evaluating D-PLEX100 for the prevention of abdominal surgery incisional site infections.
"We previously successfully completed a Phase 1b/2 study assessing D-PLEX100 in the prevention of sternal wound infection, one of the most devastating complications following open cardiac surgery, with a mortality rate of up to 40 percent when deep infection occurs" said Amir Weisberg, PolyPid's CEO. "We are now expanding this Phase 2 study to include abdominal surgery involving colorectal resection, where the risk and frequency of surgical site infection are the highest among surgeries and the need is acute."
The Phase 2 clinical trial is a prospective, multicenter, randomized, controlled, two arm single-blind study to assess safety and efficacy of D-PLEX100 administered concomitantly with the standard of care in the prevention of abdominal surgical site infections. The study is expected to be conducted in up to 300 patients undergoing elective colorectal surgery. Top-line results are anticipated in the second half of 2019.
Dr. Noam Emanuel, PolyPid's Chief Technology Officer, added, "D-PLEX100 provides localized broad-spectrum antibiotic directly in the surgical wound, generating high local concentration of antibiotics for four weeks, with a very low systemic fingerprint. This highly effective and safe approach is expected to further reduce the rates of surgical site infection as compared to systemic antibiotics prophylaxis alone."
More information on the trial can be found at: clinicaltrials.gov
PolyPid's lead product candidate, D-PLEX100, is a novel product designed to provide local anti-bacterial activity directly at the surgical site to prevent surgical site infections. Following D-PLEX100 administration into the surgical site, the drug reservoir constantly releases the entrapped broad spectrum antibiotic in a controlled manner over a predetermined period of four weeks, thus allowing prolonged infection management with increased potential to eradicate antibiotic resistant bacteria.
PolyPid is a clinical stage, biopharmaceutical company focused on developing and commercializing novel, locally administered therapies using its transformational PLEX (Polymer-Lipid Encapsulation Matrix) technology to treat a wide variety of localized medical conditions with an initial focus on the management of surgical site infections. PLEX-based products have demonstrated an excellent efficacy and safety profile during extended clinical trials, with more than 100 patients treated in clinical trials to date.