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Cytokinetics Advances Tirasemtiv to Phase III, Shares Up - Analyst Blog

Cytokinetics, Inc.CYTK announced that it has initiated a phase III VITALITY-ALS study (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS) on its lead candidate, tirasemtiv. The company's shares rose 6.8% following the company's announcement.

VITALITY-ALS will be conducted in patients suffering from probable or definite amyotrophic lateral sclerosis (ALS), who were diagnosed within 24 months with predicted slow vital capacity (SVC) of ≥70% at baseline. The primary endpoint of the study is to assess the change in SVC from baseline under tirasemtiv therapy assessed after 24 weeks of double-blind, placebo-controlled treatment.

According to Cytokinetics, around 25,000 people in the U.S. and a comparable number of patients in Europe suffer from ALS. Moreover, about 5,600 new patients are diagnosed with ALS every year in the U.S. Average life expectancy of an ALS patient is 3 - 5 years after diagnosis with only 10% of patients surviving for more than 10 years. Cytokinetics believes there is high unmet need for new drugs in this indication, which should help the tirasemtiv gain a large market share if successfully developed and commercialized. We note that Sanofi's SNY Rilutek is approved for the treatment of ALS.

Tirasemtiv enjoys orphan drug and fast track designation in the U.S. and orphan medicinal product status in the EU for the treatment of ALS. Cytokinetics owns the exclusive right to develop and commercialize tirasemtiv throughout the world.

In a separate press release, Cytokinetics announced that The ALS Association has awarded a $1.5 million grant to the company for research and development activities related to VITALITY-ALS. This should expedite the development of tirasemtiv.

Cytokinetics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Ligand Pharmaceuticals Incorporated LGND and Anacor Pharmaceuticals, Inc. ANAC . While Ligand sports a Zacks Rank #1 (Strong Buy), Anacor holds a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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