PolyPid Ltd., a late-stage biopharmaceutical company, is preparing to release topline results from its phase 3 SHIELD II trial of D-PLEX100, a drug-delivery system designed to prevent surgical site infections (SSIs). D-PLEX100 utilizes the company’s PLEX technology, a polymer-lipid matrix delivering sustained antibiotic release at the surgical site for 30 days. This technology addresses the critical need for better SSI prevention, a problem costing an estimated $10 billion annually in the US and EU.
The upcoming SHIELD II results are crucial because they could validate a new paradigm in SSI prevention. Current systemic antibiotic approaches are limited by poor penetration into the surgical site and contribute to broader antibiotic resistance. D-PLEX100’s localized, sustained-release approach offers a potentially more effective and safer alternative, directly targeting the infection site with higher antibiotic concentrations while minimizing systemic exposure. Positive results could significantly impact surgical care, improving patient outcomes and reducing the economic burden of SSIs.
D-PLEX100 has received Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product designations from the FDA. Phase 2 trials showed a statistically significant reduction in SSIs and a notable absence of deaths in the treatment group. While the previous SHIELD I trial did not meet its primary endpoint in the full patient population, a subgroup analysis showed significant efficacy in patients with larger incisions, leading to the focused design of SHIELD II. The Data Safety Monitoring Board’s recommendation to conclude SHIELD II at 800 patients, although higher than initially planned, may suggest positive efficacy trends in the interim data. PolyPid has already secured European commercialization rights through a partnership with Advanz Pharma.
Positive SHIELD II results could transform surgical infection prevention, leading to wider adoption of localized drug delivery systems. The PLEX technology’s potential extends beyond SSIs, with PolyPid’s OncoPLEX program exploring localized chemotherapy delivery for solid tumors. This positions PolyPid and its PLEX technology at the forefront of a potentially significant shift in how drugs are delivered in various clinical settings.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
