PolyPid Ltd. announced positive topline results from its Phase 3 SHIELD II trial of D-PLEX100, demonstrating a statistically significant reduction in surgical site infections (SSIs) after colorectal surgery. The trial showed a 58% reduction in SSIs, a 38% reduction in the composite primary endpoint (SSIs, all-cause mortality, and surgical reinterventions), and a 62% reduction in severe wound infections. This success validates PolyPid’s PLEX technology platform, which provides localized, sustained antibiotic delivery.
This news is crucial because SSIs represent a significant clinical challenge and financial burden, costing the US healthcare system an estimated $10 billion annually. D-PLEX100’s impressive reduction in infection rates, particularly among high-risk patients with large abdominal incisions, suggests a potential shift in the standard of care for surgical infection prevention. This localized approach also promises to minimize the overuse of systemic antibiotics, a key driver of antimicrobial resistance.
The SHIELD II trial enrolled 975 patients with incisions ≥7 cm, including those undergoing laparoscopic surgery. D-PLEX100, which utilizes a fraction of the doxycycline dose compared to systemic administration (55-164 mg vs. 6,000 mg), achieved high local antibiotic concentrations due to its unique controlled-release mechanism. This addresses a critical limitation of current prophylactic strategies, where systemic antibiotics struggle to reach adequate tissue penetration at the surgical site. PolyPid estimates a potential US market of over 12 million surgeries annually for D-PLEX100, spanning various soft-tissue procedures. Increased interest from potential commercialization partners underscores the market’s recognition of the drug’s potential.
The positive results pave the way for regulatory submissions in early 2026, including an FDA New Drug Application and a European Medicines Agency Marketing Authorization Application. Expedited review is anticipated due to the FDA’s prior designations of D-PLEX100 as a Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product. Looking beyond D-PLEX100, the success validates PolyPid’s PLEX technology for wider therapeutic uses, including its preclinical OncoPLEX program for localized chemotherapy delivery in solid tumors. This signifies not just a potential breakthrough in SSI prevention, but also a platform with diverse applications across different therapeutic areas needing localized, sustained drug delivery.
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.
