Policy & Regulation
PolyPid admits 200 patients under its Phase 2 clinical trial of D-PLEX100 in abdominal surgery
12 August 2019 -

Biopharmaceutical company PolyPid Ltd said on Monday that it has enrolled 200 patients under its Phase 2 clinical trial of its drug product candidate D-PLEX100 for the prevention of post-abdominal surgery incisional site infections.

The company added the Phase 2 trial design included a pre-planned blinded sample size re-estimation from the prior 300 patients. The re-estimation indicated that the trial can be completed after enrollment of only 200 patients.

Launched in October 2018, the Phase 2 clinical trial 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, stated the company.

In conjunction, the company expects to report top-tine results from the Phase 2 clinical trial by the end of October 2019.

According to the company, D-PLEX100 is a novel product designed to provide local and prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. The constant release of broad-spectrum antibiotic generates high local concentration of the antibiotics for four weeks, allowing effective prevention of infection after surgery with increased potential to eradicate antibiotic resistant bacteria.

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