Cytokinetics recently launched a Phase 1b clinical trial designed to evaluate the effect of CK-2127107 on physical function in older adults with limited mobility due to diseases associated with muscular weakness and/or fatigue, including chronic obstructive pulmonary disease (COPD).
The therapeutic candidate is a next-generation fast skeletal muscle troponin activator (FSTA) that is being developed in collaboration with Astellas. CK-2127107 is able to slow the rate of calcium release from the regulatory troponin complex of skeletal muscle fibers, ultimately leading to an increase in the skeletal muscles’ ability to contract.
CK-2127107 could help improve muscle function and physical performance in people with debilitating diseases that are associated with fatigue and/or muscle weakness, such as COPD or spinal muscular atrophy (SMA).
CK-2127107 was granted an orphan drug designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of SMA after being evaluated in five Phase 1 studies in healthy volunteers, assessing its safety, tolerability, bioavailability, pharmacokinetics (what the body does to a drug), and pharmacodynamics (what a drug does to the body).
The new Phase 1b double-blind, radomized study (NCT02662582) is expected to enroll a minimum of 60 subjects in the U.S., who are between 70 and 89 years of age, and who have limited mobility.
Patients will receive one of two treatment sequences: CK-2127107 first and then placebo over two 14-day periods, separated by an interval of 14 days, or the other way around. During treatment periods, patients will be given 500 mg of CK-107 or placebo two times per day. The total trial duration is estimated to be approximately 12 weeks.
“Maintaining muscle strength and mobility is essential for older adults to sustain their independence and minimize the risk of disability,” Fady I. Malik, executive vice president of research and development at Cytokinetics, said in a press release. “We look forward to data from this trial which will investigate the potential for CK-2127107 to increase skeletal muscle force and reduce muscle fatigue in frail subjects, representative of the growing population of aging baby boomers.”
Cytokinetics and Astellas are collaborating to advance novel therapies for conditions associated with muscle weakness and muscle impairment. Atellas has exclusive rights to co-develop and commercialize CK-2127107 and other FSTAs to treat non-neuromuscular and certain neuromuscular diseases, such as SMA or amyotrophic lateral sclerosis (ALS).
For more information about the trial and how to participate, please contact Astellas’ team at 800-888-7704 ext 5473 or at [email protected].