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**FX201** is an investigational intra-articular gene therapy developed by Flexion Therapeutics and subsequently by Pacira BioSciences for osteoarthritis of the knee. It uses a helper-dependent adenovirus serotype 5 vector to deliver the gene encoding interleukin-1 receptor antagonist into joint cells under the control of an inflammation-responsive promoter, with the goal of enabling local, durable production of IL-1Ra within the joint. By increasing IL-1Ra expression, the therapy is designed to inhibit signaling through the interleukin-1 receptor, suppress inflammation, reduce pain, improve function, and potentially modify disease progression in moderate-to-severe knee osteoarthritis.
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