Genascence Phase 1b DONATELLO Trial Evaluating Potential First-in-Class Gene Therapy for Knee Osteoarthritis (OA) Meets Primary Endpoint Showing GNSC-001 Was Safe and Well Tolerated Across Multiple Dosing Arms

UF startup Genascence Corporation, a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, announced positive 12-month safety and biomarker results from the Phase 1b DONATELLO clinical trial evaluating GNSC-001, a potential first-in-class gene therapy blocking interleukin 1 (IL-1) for the treatment of knee osteoarthritis (OA). Results from the 12-month analysis showed the study met the primary endpoint, demonstrating continued safety and tolerability across all doses tested, as well as the key secondary endpoint showing sustained IL-1Ra expression in synovial fluid, building on data reported through the six-month visit.