interleukin 1 – UF Innovate https://innovate.research.ufl.edu Building business on innovation Tue, 12 Aug 2025 04:47:49 +0000 en-US hourly 1 https://wordpress.org/?v=6.9.4 https://innovate.research.ufl.edu/wp-content/uploads/favicon-blue_1.png interleukin 1 – UF Innovate https://innovate.research.ufl.edu 32 32 Genascence Announces U.S. Food and Drug Administration Grants Regenerative Medicine Advanced Therapy Designation to GNSC-001 for Knee Osteoarthritis (OA) https://innovate.research.ufl.edu/genascence-announces-fda-grants-regenerative-medicine-advanced-therapy-designation-to-gnsc-001/ Wed, 16 Jul 2025 00:00:00 +0000 https://scaddev1.com/genascence-announces-fda-grants-regenerative-medicine-advanced-therapy-designation-to-gnsc-001/ UF startup Genascence Corporation, a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to GNSC-001, a potential first-in-class gene therapy blocking interleukin 1 (IL-1) for the treatment of knee osteoarthritis (OA).

GNSC-001 is a genetic medicine – a recombinant adeno-associated viral vector expressing an optimized human interleukin-1 receptor antagonist (IL-1Ra), a naturally occurring protein that blocks 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 intra-articular injection into the affected joint.

Read more about Genascence Announces U.S. Food and Drug Administration Grants Regenerative Medicine Advanced Therapy Designation to GNSC-001 for Knee Osteoarthritis (OA). ]]> Genascence Announces Six-Month Results From Phase 1b DONATELLO Trial Indicating GNSC-001 Was Safe and Well Tolerated Across Multiple Dosing Arms https://innovate.research.ufl.edu/genascence-gnsc-001-six-month-results/ Thu, 09 Jan 2025 00:00:00 +0000 https://scaddev1.com/genascence-gnsc-001-six-month-results/ UF startup Genascence Corporation, a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, announced positive interim safety and biomarker results from the Phase 1b DONATELLO clinical trial evaluating GNSC-001. GNSC-001 is an investigational AAV gene therapy product for knee osteoarthritis (OA) that encodes interleukin 1 receptor antagonist (IL-1Ra), a potent inhibitor of interleukin 1 (IL-1). Data from the six-month analysis demonstrated acceptable safety and tolerability across all doses tested, along with encouraging biomarker data.

Read more about Genascence Announces Six-Month Results From Phase 1b DONATELLO Trial Indicating GNSC-001 Was Safe and Well Tolerated Across Multiple Dosing Arms. ]]>