China-based Ji Xing Pharmaceuticals announced receiving approval from the Center for Drug Evaluation (CDE) to initiate a Phase III clinical study for its aficamten (CK-3773274) in symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This study is part of the global multi-center SEQUOIA-HCM trial.
Drug Profile and Mechanism
Aficamten is a next-generation cardiac myosin inhibitor designed to treat hypertrophic cardiomyopathy (HCM). It works by reducing the number of active myosin-producing transverse bridges per cardiac cycle, thereby inhibiting myocardial hypercontraction associated with HCM. The drug has been awarded breakthrough therapy designations in both China and the US.
Licensing Agreement
Jixing entered into a licensing agreement with Cytokinetics Inc. in July 2020, securing exclusive development and commercialization rights for aficamten in Greater China. This positions Jixing to address a significant unmet medical need in the region, as there is currently no similar approved product available in China.
Clinical Trial Details
The SEQUOIA-HCM study is a randomized, placebo-controlled, double-blind global multi-center Phase III trial assessing the efficacy of aficamten in oHCM over 24 weeks. The trial aims to enroll a total of 270 patients, marking a crucial step in the drug’s development journey.-Fineline Info & Tech
