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JUV-161 is a first-in-class recombinant fusion protein biologic developed by Juvena Therapeutics for the treatment of myotonic dystrophy type 1 (DM1) and other muscle-wasting diseases. It acts as a muscle-regenerating endocrine therapy with pro-myogenic, insulin-resistance modulating, and anti-inflammatory properties. Mechanistically, JUV-161 agonistically targets the MAPK/ERK and PI3K/AKT signaling cascades—key pathways in skeletal muscle that enhance myogenesis, muscle survival, metabolism, and strength. The drug includes an engineered human IGF-2 protein designed for subcutaneous injection. Preclinical studies have shown that administration of JUV-161 improves grip strength, increases muscle fiber cross-sectional area and density of fast-twitch fibers in animal models of DM1. The therapy is being evaluated in Phase 1 clinical trials as a weekly subcutaneous injection with the goal to improve muscle function and metabolic health in patients with DM1 and potentially sarcopenia[1][3][4][6][8].
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