Ji Xing Pharmaceuticals, a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct the Phase III ACACIA-HCM study for its drug aficamten (CK-3773274) in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) in China.
Aficamten, a next-generation cardiac myosin inhibitor, is under development to treat hypertrophic cardiomyopathy (HCM). In July 2020, Jixing entered into a licensing agreement with Cytokinetics Inc (CYTK), securing exclusive rights to develop and commercialize the drug in Greater China. The drug works by inhibiting myocardial hypercontraction associated with HCM, reducing the number of active myosin-producing transverse bridges per cardiac cycle.
The Phase III ACACIA-HCM study is a multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of aficamten on health-related quality of life in symptomatic nHCM patients compared to placebo. The study’s protocol is informed by the results of cohort 4 of the REDWOOD-HCM study, which demonstrated that treatment with aficamten significantly improves heart failure symptoms and cardiac biomarkers in nHCM patients.- Flcube.com
