Roth Affirms Cytokinetics (CYTK) at 'Buy' Following Enrollment of First VIGOR-ALS Patient
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Roth Capital affirms Cytokinetics (Nasdaq: CYTK) at Buy with a price target of $22 after the company announced the first patient has been enrolled in VIGOR-ALS (Ventilatory Investigations in Global Open-Label Research in ALS), an open-label extension clinical trial designed to assess the long-term safety and tolerability of tirasemtiv, in patients with ALS who have completed their participation in VITALITY-ALS.
Analyst Joseph Pantginis commented today,
This is an important next step for tirasemtiv with Astellas (ALPMY-NC) waiting in the wings (details below) should the VITALITY-ALS Phase III study be positive. Patients that completed the study, which fully enrolled in just over one year, are eligible to move to the extension study. To this end, placebo patients who would have been on study for one year (with no other options) have the ability to go on active drug. The primary endpoint will evaluate the effects of tirasemtiv on slow vital capacity (SVC) at 24 weeks. Change in SVC is a predictor of meaningful clinical pathology, including respiratory failure or death in ALS. The placebo-controlled, randomized double-blind stage will go on for 48 weeks and will be used to assess longer term effects. There will be a four-week double-blind withdrawal period and a four-week follow-up period. CYTK conducted a post-hoc analysis from Knopp Biosciences' EMPOWER study in order to broaden the understanding of the decline of SVC in ALS patients. We believe the analysis supports the endpoint of SVC. Data from the Phase IIb BENEFIT-ALS study show a statistically significant reduction of SVC decline. The durable response also persisted beyond the dosing period in patients tested one and four weeks after last dose. VITALITY-ALS enrolled more than 700 patients in 81 centers in 11 countries. Results from VITALITY-ALS are expected in 2H17.
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