On August 9, 2024, Cascade Pharmaceuticals announced that its Class I new drug, CS060380, with fully independent intellectual property rights, has received implicit approval for clinical trial application (IND) from the National Medical Products Administration (NMPA) in China. As part of its "dual filing" strategy targeting the global market, CS060380 previously obtained FDA implicit approval on May 10, 2024.
About CS060380
CS060380 is a small molecule agonist targeting thyroid hormone receptor β (THRβ), designed for the treatment of non-alcoholic steatohepatitis (NASH), also known as metabolic-associated steatohepatitis (MASH).
In March 2024, MGL-3196 (Resmetirom), a drug targeting the same receptor, became the first NASH treatment approved by the FDA under an accelerated pathway. It was approved for treating adult NASH patients with moderate to severe liver fibrosis, marking a major milestone in the field.
CS060380 shares the same target as MGL-3196 but represents a novel and advanced THR-β agonist developed by Cascade. It is highly specific to liver tissue and demonstrates superior preclinical data compared to MGL-3196, with significantly higher activity and selectivity. In NASH mouse models, CS060380 notably improves NAS scores and fibrosis, showing a low effective dose, remarkable efficacy, and excellent tolerability.
The clinical trial approval of CS060380 holds the promise of providing NASH patients with a safe, effective, and potentially best-in-class therapeutic option. As a highly potent and selective THR-β agonist, it represents a potential breakthrough in NASH treatment.
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