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Astellas and Cytokinetics' reldesemtiv falls short at Phase 2 in ALS

Published on 07/05/19 at 10:58am

Cytokinetics has announced at the American Academy of Neurology (AAN) that its fast skeletal muscle troponin activator (FSTA) reldesemtiv fell short of its Phase 2 primary endpoint in the treatment of amyotrophic lateral sclerosis (ALS).

Specifically, the therapy, which is in development in association with Astellas, failed to achieve a statistically significant change from baseline in slow vital capacity (SVC) after 12 weeks of treatment.

On the plus side, a post-hoc analysis pooling together dosage group data together revealed that that patients across all dosage groups declined less in SVC than those receiving placebo, with “larger and clinically meaningful differences emerging over time”. “Clinically meaningful magnitudes of effect” were seen for the primary and secondary endpoints after 12 weeks of treatment, and these differences from placebo were still evident four weeks after the last dosing of the drug.

“Results from FORTITUDE-ALS are among the most impressive we have seen in a Phase 2 clinical trial in ALS,” commented Dr Jeremy Shefner, who presented the results. “Especially noteworthy are the consistency and durability of effects observed across treatment arms on clinically meaningful endpoints.”

Matt Fellows

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