Cytokinetics Inc., a clinical-stage biopharmaceutical company, today announced it has initiated enrollment for a second phase II clinical trial of CK-2017357, the company’s lead drug candidate stemming from the company’s skeletal muscle contractility program.
CK-2017357 has been granted orphan-drug status by the United States Food and Drug Administration for the potential treatment of amyotrophic lateral sclerosis (ALS).
The company anticipates enrolling about 24 patients to conduct the study at eight to ten study centers. The clinical trial is a double-blind, randomized, placebo-controlled trial focused on evaluating the safety and tolerability of CK-2017357 in patients with ALS.
“We are pleased to announce this next trial in our program directed to the evaluation of CK-2017357 in patients with ALS,” Jesse M. Cedarbaum, MD, Cytokinetics’ vice president of Clinical Research and Operations, Neuroscience and Neuromuscular Disorders stated in the press release. “This clinical trial is designed to complement our prior single-dose phase IIa Evidence of Effect trial, which we successfully concluded in 2010, and now evaluate the safety and tolerability of CK-2017357 when administered daily to achieve steady state plasma concentrations.”
Cytokinetics CEO and President Robert I. Blum noted that the phase II trial is the seventh in a series of trials to evaluate CK-2017357 as the company moves toward phase IIb clinical trials in 2012.
The company has completed two phase I studies in healthy volunteers and two phase IIa Evidence of Effect clinical trials, one in patients with ALS and the other in patients with limping that is caused by peripheral artery disease. Additionally, the company is currently conducting phase IIa Evidence of Effect clinical trials in patients with myasthenia gravis, a disease that weakens the muscles.
In the phase IIa Evidence of Effect clinical trial in patients with ALS, the company reported that single doses of CK-2017357 evaluated appeared safe and generally well-tolerated.
For more information visit www.cytokinetics.com