PolyPid Announces Completion of Enrollment in Phase 3 SHIELD I Trial of D-PLEX₁₀₀ for Prevention of Surgical Site Infections in Abdominal Surgery
| Source: PolyPid Ltd.
PETACH TIKVA, Israel, May 31, 2022 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, announced today the completion of enrollment in the SHIELD I Phase 3 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. Following a review of unblinded efficacy data from the first 750 enrolled patients in the trial, the independent Data Safety Monitoring Board (DSMB) recently recommended concluding the study upon enrollment of 950 patients, which is the minimum number of targeted patients in the trial protocol.
“The conclusion of enrollment in the pivotal SHIELD I trial, the largest colorectal surgery clinical study conducted in more than a decade, represents an important milestone for our D-PLEX100 development program and our company as a whole,” stated Amir Weisberg, PolyPid’s Chief Executive Officer. “We look forward to the availability of top-line results from SHIELD I by the end of the third quarter of 2022. Subsequent to these expected data, we intend to pursue a pre-NDA meeting with the FDA to discuss a rolling NDA submission, consistent with the Breakthrough Therapy Designation previously granted, with potential NDA and MAA submissions planned for the first half of 2023. We are also focused on further advancing commercial pre-launch activities, while expediting partnership discussions in and outside of the United States.”
About SHIELD I
SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to a SoC alone arm, in prevention of post abdominal surgery incisional infection. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSIs event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial has enrolled patients in more than 60 centers in the United States, Europe and Israel.
D-PLEX100, PolyPid’s lead product candidate, is 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 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. D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 also received three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations for the prevention of SSIs in patients undergoing elective colorectal surgery, post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.