'CYTK' - (Cytokinetics to initiate Phase IIb clinical trial of tirasemtiv)
Sep 20, 2012 (Datamonitor via COMTEX) -- Cytokinetics, Incorporated has announced that it is proceeding to initiate a Phase IIb, randomized, double-blind, placebo-controlled, clinical trial designed to evaluate the safety, tolerability and efficacy of tirasemtiv, formerly CK-2017357, in patients with amyotrophic lateral sclerosis, or ALS. The company plans to initiate this clinical trial, known as CY 4026, in the fourth quarter of 2012.
In recent months, Cytokinetics submitted the CY 4026 protocol to the FDA and also met with the European Medicines Agency (EMA) Scientific Advice Working Party to seek advice and protocol assistance in order to include European countries in CY 4026. Based on feedback from these interactions, the company is now preparing to initiate CY 4026. This clinical trial is designed to enroll approximately 400 patients who are expected to receive tirasemtiv or placebo for three months.
The primary analysis of CY 4026 will compare the mean change from baseline in the ALS Functional Rating Scale in its revised form (ALSFRS-R) on tirasemtiv versus placebo. Secondary endpoints will include Maximum Voluntary Ventilation (MVV) and other measures of repiratory and skeletal muscle functi on. Patients will receive tirasemtiv or placebo dosed twice daily; patients taking riluzole at the time of enrollment, and who are randomized to receive tirasemtiv, will receive riluzole at a reduced dose of 50 mg daily, in a blinded manner.
"We are pleased to further evaluate tirasemtiv in patients with ALS, building upon our prior clinical experience obtained in trials of shorter duration," stated Andrew A. Wolff, MD, FACC, Cytokinetics' senior vice president of Clinical R&D and Chief Medical Officer. "Our recent interactions with regulatory authorities in the US and Europe have informed this progress to the next stage of clinical development for tirasemtiv. We look forward to initiating this important clinical trial later this year."
Tirasemtiv (formerly CK-2017357) is currently the subject of a Phase II clinical trials development program and has been granted orphan drug designation and fast track status by the FDA and orphan medicinal product designation by the EMA for the potential treatment of ALS.
Data from two completed randomized, placebo-controlled, multiple-dose, phase II clinical trials, tirasemtiv appeared to be generally safe and well-tolerated when dosed daily for two weeks at 125 mg, 250 mg, or 375 mg, first in a cohort of patients not receiving riluzole, and then in a cohort of patients receiving riluzole at a reduced dose of 50 mg daily. Adverse events and clinical assessments during treatment with tirasemtiv appeared similar, with or without co-administration of riluzole.
While the trial was not designed or powered to evaluate statistically the effects of tirasemtiv on the various outcome measures that were assessed during the study, a combined analysis of patients from two separate cohorts suggested encouraging trends in the ALSFRS-R and in MVV that appeared dose-related and potentially clinically meaningful in magnitude.
In the other Phase II clinical trial, a twice-daily dose titration regi men of tirasemtiv also appeared to be generally safe and well-tolerated. The majority of patients could be titrated successfully to a tirasemtiv dose level of 250 mg twice daily. While this trial also was not designed or powered to evaluate statistically the effects of tirasemtiv on the various outcome measures that were assessed during the study; increases were observed in ALSFRS-R that were similar in direction, and in MVV that were similar in direction and magnitude, to those observed in the aforementioned trial.
Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon
Copyright (C) 2012 Datamonitor. All rights reserved
Market Data 
Markets 
AI
