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news.Cytokinetics has reported promising data for CK-2017357 drug which met all the primaty endpoints in the first cohort of an ongoing Phase II clinical trial in patients with amyotrophic lateral sclerosis (ALS).
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CK-2017357, a fast skeletal muscle troponin activator, increases skeletal muscle force in response to neuronal input, reducing the degree of muscle fatigue.
The Phase II, double-blind placebo-controlled trial randomised 24 ALS patients to receive daily oral doses of placebo or 125 mg, 250 mg, or 375 mg of CK-2017357, respectively, for two weeks.
The primary objective of the clinical trial is to assess the safety and tolerability of CK-2017357, after multiple oral doses to steady state plasma concentrations, while the secondary objective is to evaluate the ALSFRS-R, other measures of pulmonary function, muscle strength and fatigue.
The data demonstrated that CK-2017357 was well-tolerated as a single agent at all dose levels from 125 mg daily to 375 mg daily for two weeks in these patients.
Cytokinetics president and CEO Robert Blum said the positive multi-dose tolerability data from the study will help them to advance the development of CK-2017357 to treat patients with ALS.