Cytokinetics, a biopharma company that develops muscle activators as potential treatments for certain debilitating diseases, has launched a clinical trial evaluating the efficacy, safety, tolerability, and pharmacokinetics of CK-107 in the physical function of patients with chronic obstructive pulmonary disease (COPD).
CK-2127107 (CK-107) is a novel fast skeletal muscle troponin activator that is currently under development as a potential treatment for COPD patients, as well as for other muscle-degenerative diseases.
Astellas will conduct the randomized, double-blind, placebo-controlled, two-period crossover study in collaboration with Cytokinetics.
COPD typically includes chronic bronchitis and emphysema. Treatment approaches for COPD have mainly focused on improving lung function and addressing airflow limitations caused by bronchial obstructions, but there is a considerable unmet need for disease management strategies linked to improved exercise tolerance.
Astellas and Cytokinetics expect to fulfill this unmet need by enrolling up to 40 patients with COPD in the U.S. to evaluate the effects of CK-107, in comparison to a placebo, on exercise tolerance.
The Phase 2 clinical trial will also evaluate CK-107’s effects on cardiopulmonary and neuromuscular function in comparison to a placebo, as well as resting spirometry rates.
“Patients with COPD suffer from significant exercise intolerance due to metabolic abnormalities that produce weakness in limb muscles, as well as an associated switch from slow to fast muscle fiber predominance,” said Fady I. Malik, Cytokinetics’ executive vice president and head of the company’s Research & Development Department, in a press release.
“Given CK-107’s selectivity for fast skeletal muscle fibers, we are enthusiastic about exploring this novel therapeutic strategy in this patient population,” Malik added.
CK-107’s preclinical studies have demonstrated the drug candidate’s ability to decrease the release rate of calcium from the regulatory troponin complex of fast skeletal muscle fibers. In turn, this process increases the sensitivity of the skeletal muscle to calcium, which results in increased skeletal muscle force production in response to neuronal input, also delaying the onset and reducing fatigue during repetitive muscle stimulation.
The preclinical study’s authors believe that CK-107 has the the ability to improve muscle activation and physical performance in COPD patients.
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