PUTTING OUR POWER BEHIND A POTENTIAL

PUTTING OUR POWER BEHIND A POTENTIALTREATMENT FOR ALS

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Tirasemtiv

Cytokinetics is developing tirasemtiv, a fast skeletal muscle troponin activator (FSTA), as a potential treatment for people living with ALS and certain other debilitating diseases and conditions associated with muscle weakness and fatigue or neuromuscular dysfunction.

Calcium is a key regulator of muscle contraction. Tirasemtiv selectively activates the fast skeletal muscle troponin complex and increases its sensitivity to calcium, resulting in increased skeletal muscle force and power while delaying the time to muscle fatigue.

Tirasemtiv is the subject of a large, international Phase 3 clinical trial, called VITALITY-ALS, which completed enrollment in August 2016. The trial is designed to assess its effects versus placebo on measures of respiratory function and muscle strength in people with ALS. Results from VITALITY-ALS are expected in the fourth quarter of 2017.

In October 2016, an open-label extension clinical trial called VIGOR-ALS began. The trial is designed to assess the long-term safety and tolerability of tirasemtiv, in patients with ALS who have completed their participation in VITALITY-ALS.

In July 2016, Cytokinetics granted Astellas an option right for the development and commercialization of tirasemtiv outside of North America and Europe.