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.