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Cytokinetics Sees Enough Evidence To Move Reldesemtiv Into Phase III For ALS

 
• By Mandy Jackson

The Astellas-partnered drug did not reach statistical significance on any FORTITUDE-ALS endpoints, but clinically significant results over time justify a longer Phase III study that's likely to enroll ALS patients with a faster rate of disease progression.

Titled book Amyotrophic Lateral Sclerosis along with medical equipment, conceptual image - Image
Cytokinetics may move reldesemtiv into Phase III in ALS in 2020. • Source: Shutterstock

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...

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