PolyPid Granted Breakthrough Therapy Designation from FDA for D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Colorectal Surgery

PolyPid Ltd. (Nasdaq: PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that D-PLEX₁₀₀ has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of surgical site infections (SSIs) in patients undergoing elective colorectal surgery.

Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition so patients may have access to therapies through FDA approval as soon as possible. This designation is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

“The Breakthrough Therapy Designation in the field of anti-infective drugs is rather rare, and further supports the urgency to develop new innovative therapies to prevent SSIs,” said Amir Weisberg, PolyPid’s CEO. “It also reflects on the promising clinical data of D-PLEX₁₀₀ in the prevention of SSIs in complex surgical settings, such as colorectal abdominal surgeries. We are looking forward to working closely with the FDA to make D-PLEX₁₀₀ available to surgeons and patients as quickly as possible. Our ongoing Phase 3 pivotal studies in abdominal surgery – SHIELD I and SHIELD II – are on track.”

The Breakthrough Therapy Designation for D-PLEX₁₀₀ is based on conclusive positive results from a Phase 2 clinical trial evaluating D-PLEX₁₀₀ for the prevention of surgical site infections (SSIs) in abdominal colorectal surgery. The Phase 2 clinical trial was a prospective, multicenter, randomized, controlled two arm study in 201 patients and demonstrated that the local administration of D-PLEX₁₀₀ resulted in a statistically significant decrease in SSIs of 59 percent in the Intent to Treat (ITT) population (p=0.0086), and a decrease of 69 percent in the Per Protocol population (n=179; p=0.0024), as compared to the standard of care alone.

D-PLEX₁₀₀ previously received two Fast Track Designations from the FDA for the prevention of post-abdominal surgery incisional infections and for the prevention of sternal wound infections post-cardiac surgery, as well as two Qualified Infectious Disease Product designations (QIDP’s) in the same indications.

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