US-based Cytokinetics has started a Phase II FORTITUDE-ALS clinical trial of CK-2127107 for the treatment of patients with amyotrophic lateral sclerosis (ALS).
CK-2127107 is a fast skeletal muscle troponin activator (FSTA) designed to slow the rate of calcium release from regulatory troponin complex of fast skeletal muscle fibres.
The product candidate is being developed by the firm in collaboration with Astellas Pharma for treating debilitating diseases and skeletal muscle weakness disorders and / or fatigue.
The double-blind, randomised, placebo-controlled, parallel group, dose ranging Phase II trial will assess 150mg, 300mg and 450mg of CK-2127107 orally and twice a day in around 450 patients across Canada and the US.
The primary efficacy endpoint of the trial is the change from baseline in the percent predicted slow vital capacity (SVC) at 12 weeks.
Secondary endpoints such as measure of change from baseline in the mega-score of muscle strength, incidence and severity of treatment-emergent adverse events (TEAEs) and CK-2127107’s plasma concentrations will also be monitored during the trial.
Cytokinetics research and development executive vice-president Fady Malik said: “Under our collaboration with Astellas, we look forward to now exploring the potential of this next-generation FSTA in a fourth patient population, in which it may alter the decline of muscle function and performance.
“This clinical trial offers an opportunity to assess exploratory measures of patient function that may also prove informative in further quantifying ALS disease progression.”
The trial’s exploratory endpoints include quantitative measure of disease progression via speech production characteristics and handwriting abilities over time, change in quality of life, and self-respiratory function assessments.