Cytokinetics, Incorporated (Nasdaq: CYTK) has announced the initiation of a Phase 1 clinical study of CK-4015089 (CK-089), a fast skeletal muscle troponin activator (FSTA). The first participants have been dosed in this randomized, double-blind, placebo-controlled trial, which will evaluate the safety, tolerability, and pharmacokinetics of CK-089 in healthy human participants.
Rationale for CK-4015089 Development
CK-089 is a novel, selective, oral, small molecule FSTA with potential therapeutic application for specific types of muscular dystrophy and other conditions involving impaired muscle function. The drug is designed to selectively activate the fast skeletal muscle troponin complex by increasing its affinity for calcium. Preclinical research has indicated that CK-089 has higher bioavailability, solubility, and pharmacodynamic efficacy compared to previously developed FSTAs. In preclinical models, CK-089 improved muscle force and function in a mouse model of muscular dystrophy associated with muscle weakness and fatigue.
Phase 1 Clinical Trial Details
The Phase 1 trial is a multi-part study involving single and multiple ascending doses of CK-089. Each cohort consists of 10 participants. The primary objective is to evaluate the safety, tolerability, and pharmacokinetics of CK-089 when administered orally as single or multiple doses to healthy participants.
Executive Perspective
"We are pleased to begin clinical development of CK-089, a promising fast skeletal muscle troponin activator arising from our research in neuromuscular diseases," said Stuart Kupfer, M.D., Senior Vice President, Chief Medical Officer at Cytokinetics. "In the pre-clinical setting, CK-089 increased muscle force and function in animal models of a neuromuscular disease characterized by muscle weakness, atrophy and fatigue, suggesting it may have therapeutic application to a specific type of muscular dystrophy but also other conditions of impaired muscle function."
