Based on promising effects on respiratory function, and follow-up discussions with statisticians, clinicians and the US Food and Drug Administration, Cytokinetics announced its decision to move forward with a Phase III clinical trial of tirasemtiv in ALS. Earlier this year, Cytokinetics presented disappointing results of the company’s Phase IIb clinical trial to evaluable safety, tolerability and efficacy of tirasemtiv for treating ALS. The drug, which increases sensitivity of the fast skeletal muscle troponin complex to calcium and thereby increases skeletal muscle force, did not lead to a significant change in a functional score in ALS patients, called the ALS Functional Rating Scale in its revised form (ALSFRS-R). However, treatment with the drug decreased the rate of decline of Slow Vital Capacity consistently across all subgroups of ALS patients, results which led to the decision to continue development of the drug for ALS.
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