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KMR301 (also known as FHND5032) is an oral, small-molecule inducer of microRNA-124 (miR-124) currently in preclinical development for the treatment of autoimmune and inflammatory diseases. Originally developed by Jiangsu Chia Tai Feng Hai Pharmaceutical (CTFH), the asset was acquired by Formation Bio (formerly TrialSpark) and is being progressed through its subsidiary, Kenmare Bio. miR-124 is an anti-inflammatory microRNA that is typically downregulated in various chronic inflammatory conditions, including ulcerative colitis. By inducing the expression or activity of miR-124, KMR301 aims to restore homeostatic immune regulation and reduce inflammation. The drug has demonstrated efficacy in preclinical models of ulcerative colitis and is scheduled to enter clinical trials in 2026.
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