The California-based biopharmaceutical company Cytokinetics has announced the initiation of a Phase III clinical trial of its drug tirasemtiv in ALS. The drug, a small molecule troponin activator, works in part by augmenting calcium sensitivity and thereby increasing skeletal muscle force even with diminishing neural input (see Feb 2012 news). In the Phase II clinical trials concluded last year, the company reported no significant changes in ALSFRS. However, the drug exerted a statistically significant and potentially clinically beneficial effect on respiratory function in ALS patients, as assessed by slow vital capacity (SVC), an indicator of muscle strength for those that control breathing (see April 2014 news; Oct 2014 news). The company aims to confirm and extend these promising findings with a year-long Phase III clinical trial, entitled VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS). The trial will enroll close to 500 participants with ALS throughout North America and Europe.
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