Cytokinetics' CK-2017357 drug has met all primary endpoints in the first cohort of an ongoing Phase II clinical trial in patients with amyotrophic lateral sclerosis.
CK-2017357, a fast skeletal muscle troponin activator, increases skeletal muscle force in response to neuronal input, reducing the degree of muscle fatigue.
The ongoing Phase II, double-blind and placebo-controlled trial involves 24 randomised amyotrophic lateral sclerosis patients, who are receiving daily oral doses of a placebo, or a 125mg, 250mg, or 375mg dose of CK-2017357 for two weeks.
The primary aim of the clinical trial is to evaluate the safety and tolerability of CK-2017357, after multiple oral doses to steady-state plasma concentrations. #
The secondary objective is to evaluate the ALSFRS-R, other measures of pulmonary function, muscle strength and fatigue, and physician and patient global assessments in amyotrophic lateral sclerosis patients.
The study also showed that CK-2017357 was well-tolerated as a single agent at all dose levels from 125mg daily to 375mg daily for two weeks in patients not currently taking riluzole.
Data from the trial also reported a considerable increase in the maximum volume of air patients could inhale and exhale in ten seconds (maximum voluntary ventilation) at six and 24 hours after taking 500mg of CK-2017357.
''We are pleased that Part A of this clinical trial successfully achieved its primary objective in demonstrating that CK-2017357 was well-tolerated when dosed daily in these patients with amyotrophic lateral sclerosis and provides encouraging information with respect to a key question regarding the abatement of dizziness with continued dosing," said Cytokinetics Clinical Research and Operations Neuroscience and Neuromuscular Disorders vice-president Jesse Cedarbaum.
Cytokinetics president and CEO Robert Blum said the positive multi-dose tolerability data from the study will help to advance the development of CK-2017357 for the potential treatment of patients with the condition.
"Advancing CK-2017357 into later-stage development remains an important corporate priority and we look forward to seeing the results from our other ongoing Phase II clinical trials that may also guide our preparations," Blum added.
Caption: Cytokinetics' CK-2017357 drug has met all primary endpoints