A novel therapy designed to provide prolonged and constant release of antibiotic helped prevent surgical site infections in patients who underwent abdominal surgeries, according to the manufacturer, PolyPid.
Researchers tested the safety and efficacy D-PLEX100 in a phase 2 clinical trial comprising 201 patients and found that it was better at preventing infection than standard of care, according to a press release.
“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,” Amir Weisberg, CEO of PolyPid said in the release.
D-PLEX100 is administered into the surgical site and provides constant release of doxycycline in high local concentration for 4 weeks. It is also indicated for the prevention of surgical site infections after cardiac surgery.
In the phase 2 trial, investigators randomly assigned patients who were undergoing abdominal surgery to receive D-PLEX100 in addition to standard of care or standard of care alone.
The primary endpoint of the study was infection rate based on the proportion of patients with a surgical site infection event within 30 days after surgery, and treatment failure was defined as mortality within 30 days after surgery.
In the study’s intention to treat analysis, researchers found that administration of D-PLEX100 decreased surgical site infections 57% compared with standard of care alone (P < .0136). In the per protocol analysis, which included patients who completed the study without any major protocol deviations (n = 179), D-PLEX100 decreased surgical site infections by 68% compared with standard of care alone (P < .0024).
Within 60 days after surgery, five patients in the standard of care arm died compared with none in the D-PLEX100 group. There were no reports of treatment-related adverse events, according to the release.
“Based on these compelling results, we intend to conduct an end of phase 2 meeting with the U.S. FDA,” Weisberg said in the release. “Following our interactions with the FDA, we expect to be in a position to submit an investigational new drug amendment to conduct a phase 3 trial for the prevention of post-abdominal surgical site infections.”
Disclosures: Weisberg is employed by PolyPid.
For more information: