PolyPid announced that the first patient has been enrolled and randomized in a Phase 3 clinical trial called SHIELD (Surgical site Hospital acquired Infection prEvention with Local D-plex). SHIELD will evaluate D-PLEX100 plus the standard of care (SoC) versus SoC only for the prevention of sternal wound infection post-cardiac surgery. Juan A. Crestanello, M.D., a cardiovascular and thoracic surgeon at Mayo Clinic, 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 program," said Amir Weisberg, PolyPid's 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 U.S. Food and Drug Administration, represents a key advancement toward our U.S. 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, multicenter, blinded, randomized 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 enroll a minimum of 1,284 subjects, with a maximum of about 1,600 subjects, as defined by the adaptive study design, in approximately 45 centers in the U.S., 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 SoC versus SoC only in the prevention of sternal wound infection post-cardiac surgery. In this trial, none of the 58 patients treated with D‐PLEX100 plus SoC 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 SoC 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 SoC 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.
PolyPid's lead drug product candidate, D-PLEX100, is a novel product designed to provide local prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic, doxycycline, resulting in high local concentration for a period of four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations from the FDA for the prevention of sternal wound infection post-cardiac surgery and for the prevention of post-abdominal surgery incisional infection.
