Phase 3 trial for D-PLEX100 technology to assess efficacy in preventing sternal wound infection


PolyPid optimized therapeutics sternal wound infection study

Pharmaceutical company PolyPid has announced that the first patient has been enrolled and randomised in a phase 3 clinical trial called SHIELD (Surgical site Hospital-acquired Infection prEvention with Local D-plex). SHIELD will evaluate PolyPid’s D-PLEX100 plus standard of care, versus standard of care only for the prevention of sternal wound infection post-cardiac surgery.

According to a statement, PolyPid’s D-PLEX technology enables prolonged-release therapeutics for the treatment of wound infections. Juan A Crestanello, a cardiovascular and thoracic surgeon at Mayo Clinic and based in Rochester, Minnesota, is the principal investigator of the SHIELD study.

“The initiation of this Phase 3 clinical trial represents a significant milestone for our D-PLEX100 development programme,” said Amir Weisberg, PolyPid CEO. “Cardiac surgery is a key bone surgical model for D-PLEX100. We believe that this trial, combined with our previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations for the prevention of sternal wound infection post-cardiac surgery from the US Food and Drug Administration (FDA), represents a key advancement toward our US regulatory approval strategy and our ability to provide a novel solution for surgeons and their patients as expeditiously as possible.”

SHIELD is a prospective, multinational, multicentre, blinded, randomised study designed to assess the efficacy and safety of D-PLEX100 in the prevention of sternal wound infection post-cardiac surgery.  The primary endpoint of the trial is the infection rate, as measured by the proportion of subjects with a sternal wound infection event within 90 days post-sternotomy.

The trial will enrol a minimum of 1,284 subjects, with a maximum of about 1,600 subjects, as defined by the adaptive study design, in approximately 45 centres across the USA, Europe and Israel.

PolyPid previously completed a single-blinded and double-arm randomized Phase 1b/2 trial evaluating the safety and efficacy of D‐PLEX100  plus standard of care, versus standard of care only, in the prevention of sternal wound infection post-cardiac surgery.

In this trial, none of the 58 patients treated with D‐PLEX100 plus standard of care had a primary sternal wound infection within 90 days post-surgery, as compared to one of the 23 patients in the SoC arm, representing a 4.3% infection rate. In addition, in the D‐PLEX100 plus standard of care arm, 3.4% of patients were treated with IV antibiotics directly due to a sternum wound discharge adverse event, as compared to 21.7% in the standard of care only group.

D‐PLEX100 was observed to be generally well-tolerated, with no drug-related severe adverse effects and no drug-related wound healing issues at the incision site.


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