PolyPid Ltd. (Nasdaq: PYPD) has announced the advancement of its SHIELD II Phase 3 trial for D-PLEX100, a novel therapy designed to prevent surgical site infections (SSIs) following abdominal colorectal surgery. The Data Safety Monitoring Board (DSMB) recommended continuing enrollment to 800 patients after reviewing unblinded efficacy data from the first 430 patients enrolled.
This decision signals a potentially positive efficacy trend for D-PLEX100, according to Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. The DSMB also had the option to recommend stopping the trial due to futility or overwhelming efficacy, or to reassess the trial’s sample size to a maximum of 1,100 patients.
SHIELD II Trial Design and Progress
The SHIELD II trial (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double-blind Phase 3 study. It is designed to evaluate the efficacy and safety of D-PLEX100 when administered with the standard of care, including prophylactic systemic antibiotics, compared to the standard of care alone. The primary endpoint is the proportion of subjects experiencing a surgical site infection, reintervention, or mortality within 30 days post-surgery.
As of the announcement, 630 patients have been enrolled, with the remaining 170 expected to be recruited by Q1 2025. Top-line results are anticipated in Q2 2025. The trial is being conducted in centers across the United States, Europe, and Israel.
Financial Runway Extended
Concurrent with the DSMB recommendation, PolyPid has secured a private placement financing of $14.5 million, with potential additional proceeds of up to $27 million from warrants. This financing extends the company's cash runway into Q3 2025, beyond the expected SHIELD II top-line results. The company plans to use the funds to complete the trial and prepare for potential NDA and MAA submissions.
Regulatory Pathway
D-PLEX100 has been granted Fast Track and Breakthrough Therapy designations by the U.S. Food and Drug Administration (FDA). Upon positive Phase 3 data, PolyPid plans to submit an NDA, potentially expediting the review process.
About D-PLEX100
D-PLEX100 is PolyPid’s lead product candidate, designed to provide local, prolonged, and controlled antibacterial activity directly at the surgical site. The PLEX (Polymer-Lipid Encapsulation matriX) technology allows for the sustained release of doxycycline, a broad-spectrum antibiotic, over 30 days, aiming to prevent SSIs, including those caused by antibiotic-resistant bacteria.
Potential Impact
If approved, D-PLEX100 could address a significant unmet need in preventing SSIs, which remain a major cause of morbidity, mortality, and increased healthcare costs following surgery. The company believes the DSMB’s recommendation increases the trial’s overall probability of success.
