With Phase III Failure, Cytokinetics Shelves Tirasemtiv, Pivots To ALS Backup
Partnered with Astellas, the San Francisco-area biotech hopes next-generation CK-107 will succeed in a measure of slow vital capacity due to stronger potency and better tolerability compared to tirasemtiv.
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With a data monitoring committee finding no signs of efficacy in a Phase III trial of ALS candidate reldesemtiv, Cytokinetics can conserve cash and center on aficamten for hypertrophic cardiomyopathy.
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.
The two firms hope improvement in the six-minute walk test might be accepted by the US FDA as registrational endpoint for reldesemtiv in spinal muscular atrophy. Blackstone acquires Clarus, while Merck licenses TriNKETs from Dragonfly.