Genascence Granted FDA Fast Track Designation for GNSC-001 in Patients With Osteoarthritis (OA) of the Knee

UF Startup Genascence Corporation (“Genascence”), a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for GNSC-001, a potential first-in-class gene therapy for the treatment of patients with osteoarthritis (OA) of the knee.

GNSC-001 is a genetic medicine – a recombinant adeno-associated vector (AAV) expressing an optimized form of interleukin-1 receptor antagonist (IL-1Ra), a naturally occurring protein that blocks interleukin-1 (IL-1) signaling. IL-1 is considered one of the key mediators involved in the pathogenesis of OA, causing inflammation, joint pain, and cartilage destruction. GNSC-001 is designed to offer long-term, sustained inhibition of IL-1 following a single injection into the affected joint.

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