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news.Cytokinetics, a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, has opened a Phase IIa 'Evidence of Effect' (EoE) clinical trial of CK-2017357 for patients with amyotrophic lateral sclerosis (ALS).
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Cytokinetics claimed that CK-2017357 is a fast skeletal muscle troponin activator and is the lead drug candidate that has emerged from the company’s skeletal muscle contractility program. CK-2017357 selectively activates the fast skeletal muscle troponin complex and increases its sensitivity to calcium, resulting in increased skeletal muscle force.
Earlier, CK-2017357 was granted an orphan-drug designation by the FDA in March 2010, for the potential treatment of ALS.
Reportedly, the Phase IIa EOE clinical trial is a double-blind, randomised, placebo-controlled, three-period crossover, pharmacokinetic and pharmacodynamic study of CK-2017357 in male and female patients with ALS.
The trial is expected to enroll at least 36 and up to 72 patients. The primary objective of the trial is to evaluate the pharmacodynamic effects of CK-2017357 on measures of skeletal muscle function or fatigability in patients with ALS.
Whereas, the secondary objectives of the clinical trial are to evaluate the relationship between the plasma concentration of CK-2017357 and its pharmacodynamic effects, to evaluate the safety and tolerability of the two single doses of CK-2017357 administered orally to patients with ALS, and to evaluate the effects of CK-2017357 on patient- and investigator-determined global functional assessments.
Andrew Wolff, senior vice president of clinical research and development and chief medical officer of Cytokinetics, said: “This hypothesis-generating clinical trial is designed to evaluate evidence of pharmacodynamic effects of CK-2017357 associated with potentially increased skeletal muscle performance in patients with ALS. Based on non-clinical and clinical results, we believe that we may demonstrate relevant effects with CK-2017357, even after single dose administration.
“We believe that results from this trial, as well as those from our other planned Phase IIa ‘Evidence of Effect’ trial in patients with claudication, have the potential to further inform our understandings of potential therapeutic applications that this novel drug candidate may have in diseases of impaired muscle function.”