Cytokinetics, Astellas: COPD trial did not meet primary endpoint

Cytokinetics (CYTK) and Astellas Pharma (ALPMY) provided an update for their collaborative skeletal muscle program, including clinical trial updates for reldesemtiv in neuromuscular and non-neuromuscular conditions. Astellas recently completed a Phase 2 clinical trial designed to assess the potential effect of reldesemtiv compared to placebo on exercise tolerance, assessed as change from baseline in Constant Work Rate endurance time over two weeks, in approximately 40 patients with Chronic Obstructive Pulmonary Disease, or COPD. Additionally, the trial assessed other cardiopulmonary and neuromuscular effects and resting spirometry. In addition, the safety, tolerability and pharmacokinetics of reldesemtiv were assessed. This trial of reldesemtiv did not meet the primary endpoint and did not demonstrate a statistically significant treatment difference in any of the secondary endpoints. Adverse events were similar between groups receiving reldesemtiv and placebo. Astellas has been conducting a Phase 1b clinical trial designed to assess the effect of reldesemtiv versus placebo on skeletal muscle fatigue in approximately 60 subjects who are 70 to 89 years of age and who have limited mobility. Endpoints measured include the change from baseline versus 14 days of treatment in sum of peak torque during isokinetic knee extensions. Additionally, the trial is designed to assess the effects of reldesemtiv on physical performance as well as the safety, tolerability and pharmacokinetics of reldesemtiv. An interim analysis of this study was recently conducted, and the Independent Data Monitoring Committee determined that the pre-defined criteria for lack of efficacy of reldesemtiv had been met; Astellas has notified investigators to halt further enrollment in the trial. As recently announced, Cytokinetics and Astellas are advancing a next-generation FSTA into IND-enabling studies, which triggers a $2M milestone payment from Astellas to Cytokinetics. This potential drug candidate was designed to have different physicochemical properties than reldesemtiv and may be developed for the treatment of diseases and conditions associated with non-neuromuscular etiology and pathogenesis. The companies are also continuing their joint research program with Astellas providing sponsorship of Cytokinetics’ activities through 2019.
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