Cytokinetics Inc. saw no statistically significant results on the major primary and secondary endpoints in its Phase II clinical trial of reldesemtiv in amyotrophic lateral sclerosis (ALS), but the company and partner Astellas Pharma Inc. still plan to start a Phase III trial, possibly in 2020, based on clinically meaningful data points in the mid-stage FORTITUDE-ALS study.
Reldesemtiv is the second ALS candidate from Cytokinetics' pipeline of muscle activators that has looked promising enough to the company in Phase II to justify a Phase III program in ALS – the newer drug was the firm's fallback option when the first candidate, tirasemtiv, failed in Phase III in 2017