Keixing Announces Breakthrough Therapy Designation for aficamten in China

Based on the results of REDWOOD-HCM and the Phase 1 clinical study in China, the National Medical Products Administration granted breakthrough therapy designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy

On February 16, 2022, Keixing Pharmaceutical announced that the Center for Drug Evaluation of the State Drug Administration granted aficamten (CK-3773274 tablets) breakthrough therapy designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM)

Based on the results of the clinical trials, in particular the results of the REDWOOD-HCM Cohort 1 and Cohort 2 of the global Phase 2 clinical trial of aficamten in patients with symptomatic oHCM, the Centers for Drug Evaluation has granted aficamten approval for the treatment of symptomatic oHCM, a serious life-threatening disease.

In December 2021, Keixing announced the successful completion of the China Phase 1 clinical trial of aficamten, a potential next-generation cardiac myosin inhibitor for the treatment of hypertrophic cardiomyopathy (HCM)

About aficamten

Aficamten is an investigational selective small-molecule cardiac myosin inhibitor.

In July 2020, Keixing signed a licensing cooperation agreement with Cytokinetics, Incorporated

About Hypertrophic Cardiomyopathy (HCM)

Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiovascular disease, with a prevalence of 80/100,000 in China, and an estimated HCM patient with more than 1.

At present, there are no approved drugs for HCM directly in China.

About REDWOOD-HCM

Aficamten's breakthrough therapy designation is primarily based on the REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) study cohort 1 and The results of 2, a phase 2 clinical study of aficamten in patients with symptomatic oHCM, were presented at the Heart Failure Association of America (HFSA) annual academic meeting in September 2021

About SEQUOIA-HCM

SEQUOIA-HCM is a randomized, placebo-controlled, multicenter, double-blind, phase 3 study in patients with symptomatic obstructive hypertrophic cardiomyopathy

The primary objective of the SEQUOIA-HCM study was to evaluate the effect of aficamten on exercise capacity in patients with symptomatic oHCM by changes in maximal oxygen uptake (pVO2) determined by cardiopulmonary exercise testing (CPET) from baseline to week 24

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(Original abridged)