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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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.
Early engagement with US payers suggests openness to covering a liquid form of riluzole, because the tablet version is proven, but it's impossible to take for many ALS patients, says Italfarmaco subsidiary ITF Pharma.