PolyPid's D-PLEX100 Shows Promise in Reducing Surgical Site Infections

A SHIELD II Phase 3 trial of PolyPid’s D-PLEX100 showed “positive topline results.” Globe Newswire has the press release.

D-PLEX100 is a product “designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site.”

The study in question specifically aimed for the “prevention of SSIs in patients undergoing abdominal colorectal surgery with large incisions.” Key findings from the study include “a significantly lower proportion of primary endpoint events among patients who received D-PLEX100 plus SoC [standard of care] compared to SoC alone. … The primary endpoint is the combination of deep and superficial SSIs, all-cause mortality and surgical reinterventions at the same incision of the original index surgery.” Certain key secondary endpoints identified also saw reductions.

The risk of SSIs in colorectal patients “as recently been documented to approach 23% in patients with multiple comorbid risk factors.” According to Charles E. Edmiston, Jr., an emeritus professor of surgery, the findings show “significant risk-reduction benefit by reducing in-wound sepsis risk.”