Cytokinetics, Inc. (CYTK)

[H2R]

Calendar Update: On Track for ALS Q4 2017

From the Q1 2017 Reporting:
http://ir.cytokinetics.com/phoenix.zhtml?c=142156&p=irol-newsArticle&ID=2266649

Recent Highlights and Upcoming Milestones

Skeletal Muscle Program

tirasemtiv

Convened the third Data Monitoring Committee Meeting for VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS); the Committee recommended the continuation of VITALITY-ALS without modification.

Continued conduct of VITALITY-ALS and enrollment 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 participation in VITALITY-ALS.

Announced the advancement of our research collaboration with Origent Data Sciences to prospectively validate Origent’s computer model designed to predict the course of disease progression using baseline data from VITALITY-ALS. The model is expected to be completed prior to analyzing results of VITALITY-ALS.

Conducted clinical, regulatory, non-clinical and other planning activities intended to support potential regulatory filings and registration of tirasemtiv in North America and Europe.

Engaged Health Technology Assessment organizations to understand payor interests and to inform market access activities in ALS.

Expect to continue to enroll patients who complete VITALITY-ALS into VIGOR-ALS throughout 2017.

Expect results from VITALITY-ALS in Q4 2017.

CK-2127107

Announced pre-clinical data for CK-2127107 showing that this next-generation fast skeletal troponin activator (FSTA) improves muscle function in mouse models of spinal muscular atrophy (SMA). The results were presented at the MDA Scientific Conference in Arlington, VA.

Completed enrollment of Cohort 1 in the Phase 2 clinical trial of CK-2127107 in patients with SMA, conducted by Cytokinetics in collaboration with Astellas; announced that Cohort 2 opened enrollment.

Expect data from the Phase 2 clinical trial of CK-2127107 in patients with SMA in 2H 2017.

Expect Astellas to continue enrollment in a Phase 2 clinical trial of CK-2127107 in patients with COPD in 2017.

Expect Astellas to begin a Phase 1b clinical trial of CK-2127107 in elderly patients with limited mobility in Q2 2017.

Expect to begin a Phase 2 clinical trial of CK-2127107 in patients with ALS in mid-2017.

Cardiac Muscle Program

omecamtiv mecarbil

Announced additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, showing that omecamtiv mecarbil improved measures of left ventricular myocardial deformation, a marker of myocardial function that has been related to outcomes. These results further support the direct effect of omecamtiv mecarbil to improve myocardial contractile function. The results were presented in a Poster Session at the American College of Cardiology’s 66th Annual Scientific Session (ACC.17) in Washington, D.C.

Continued to activate sites and enroll patients in GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil which is being conducted by Amgen, in collaboration with Cytokinetics.

Expect data from a Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients with chronic heart failure in Q3 2017.

Expect continued enrollment of patients with chronic heart failure in GALACTIC-HF throughout 2017.