PolyPid's D-PLEX₁₀₀ Wins BioTech Breakthrough Award for "Therapeutics Solution of the Year"

Core Insights - PolyPid Ltd. has announced that its lead candidate D-PLEX₁₀₀ has been awarded "Therapeutics Solution of the Year" by BioTech Breakthrough, highlighting its innovative approach to improving surgical outcomes [1][3]. Product Overview - D-PLEX₁₀₀ utilizes PolyPid's proprietary PLEX technology to deliver localized antibiotic treatment, specifically doxycycline, directly at the surgical site for a duration of 30 days, aimed at preventing surgical site infections (SSIs) [2][4]. - The product has shown a statistically significant 58% relative risk reduction in SSIs following abdominal colorectal surgery, as demonstrated in the Phase 3 SHIELD II trial [4]. Industry Context - Surgical site infections are a major concern in healthcare, accounting for 20% to 31% of all hospital-acquired infections, leading to increased hospital stays and healthcare costs [3][4]. - D-PLEX₁₀₀ addresses the challenge of standard antibiotics failing to reach surgical sites effectively due to disrupted blood supply, thus potentially transforming surgical care and improving patient outcomes [3][4]. Regulatory Status - D-PLEX₁₀₀ has received Breakthrough Therapy Designation, three Qualified Infectious Disease Product (QIDP) designations, and three Fast Track designations from the U.S. Food and Drug Administration, with a New Drug Application (NDA) submission expected in early 2026 [4][5]. Company Profile - PolyPid Ltd. is a late-stage biopharma company focused on enhancing surgical outcomes through controlled, prolonged-release therapeutics, with a pipeline that includes innovations in oncology, obesity, and diabetes [5].