PolyPid announced positive top-line results from its Phase 2 clinical trial evaluating D-PLEX100 for the prevention of surgical site infections (SSI) in abdominal surgery.
The Phase 2 clinical trial enrolled 201 patients and 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 the SoC control arm, in the prevention of surgical site infection (superficial and deep) in patients undergoing abdominal surgery. The primary endpoint is the infection rate as measured by the proportion of subjects with an SSI event within 30 days post-surgery. Mortality within 30 days was considered as treatment failure.
In the Intent to Treat (ITT) population, the local administration of D-PLEX100 resulted in a statistically significant decrease in SSIs of 57 percent, compared to SoC alone (p<0.0136). In the Per Protocol population (n=179), which includes all ITT subjects who completed the study without any major protocol deviations, patients treated with D-PLEX100 achieved a statistically significant decrease in SSIs of 68 percent, as compared to SoC alone (p<0.0024).
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Within the first 60 days post-surgery, there were five deaths in the SoC treatment arm, as compared to zero in the D-PLEX100 treatment arm. In addition, there were no D-PLEX100-related serious adverse events.
“This was a robust clinical trial in one of the most complex surgical setting for SSIs, abdominal surgery with colorectal resection,” said Prof. Aviram Nissan, M.D., Head of the Department of General and Oncology Surgery at Sheba Medical Center and clinical investigator for the Phase 2 trial. “The vast majority of the patients in the study had colorectal cancer, making the results of this study especially impressive. I look forward to further evaluating D-PLEX100 in a Phase 3 clinical trial.”
“We are extremely pleased with the totality of these top-line data, which represent our first results for D-PLEX100 from a large, blinded, prospective clinical trial designed with FDA input,” said Amir Weisberg, PolyPid’s CEO. “Based on these compelling results, we intend to conduct an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). Following our interactions with the FDA, we expect to be in a position to submit an Investigational New Drug (IND) amendment to conduct a Phase 3 trial for the prevention of post-abdominal SSIs. This would be the second surgical model for D-PLEX100 to enter Phase 3. In our most advanced clinical program for D-PLEX100, for the prevention of post-cardiac surgery sternal infections, we expect the first patient in our Phase 3 trial to be enrolled before year-end.”
PolyPid’s lead drug product candidate, D-PLEX100, is a novel product designed to provide local 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, doxycycline, resulting in high local concentration for a period of four weeks. This allows effective prevention of infection after surgery with increased potential to eradicate antibiotic resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (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.