Cytokinetics, Incorporated Announces Receipt of FDA Feedback Regarding Reldesemtiv in Patients with SMA
January 22, 2019 at 07:30 am EST
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Cytokinetics, Incorporated announced that it has received feedback from the U.S. Food and Drug Administration (FDA) that the Six Minute Walk Test (6MWT) is an acceptable primary efficacy endpoint for a potential registration program for reldesemtiv in patients with spinal muscular atrophy (SMA) who have maintained ambulatory function. The FDA also recommended adding a global function scale as a secondary endpoint, such as the Hammersmith Functional Motor Scale – Expanded (HFMSE). In collaboration with Astellas, Cytokinetics is developing reldesemtiv as a potential treatment for people with SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue. The companies are discussing potential next steps regarding the ongoing development program for reldesemtiv in this patient population. Results from a Phase 2 clinical study of reldesemtiv in patients with SMA showed a statistically significant exposure-response relationship in changes from baseline in Six Minute Walk Distance (6MWD), a sub-maximal exercise test of aerobic capacity and endurance. The study also showed statistically significant increases for Maximal Expiratory Pressure (MEP), a measure of strength of respiratory muscles. Other assessments, including the HFMSE, did not demonstrate differences between reldesemtiv versus placebo. Adverse events in the Phase 2 study in patients with SMA were similar between treatment groups receiving reldesemtiv and placebo. Cytokinetics is preparing to conduct an additional Phase 1 study of reldesemtiv in healthy volunteers designed to assess whether higher doses than were evaluated in the Phase 2 study of patients with SMA may result in higher plasma concentrations. This study is expected to begin in the first quarter. Cytokinetics recently announced the completion of patient enrollment in FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), a Phase 2 clinical trial designed to assess the change from baseline in the % predicted slow vital capacity (SVC) and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv (formerly CK-2127107). Results are expected in the first half of 2019.
Cytokinetics, Incorporated is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. The Company specializes in muscle biology and the mechanics of muscle performance. It is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Its cardiac muscle contractility program is focused on the cardiac sarcomere. Its clinical-stage drug candidates are: aficamten, which is a next-in-class cardiac myosin inhibitor; omecamtiv mecarbil, which is a cardiac myosin activator; CK-586, which is an additional cardiac myosin inhibitor, and CK-136, which is a cardiac troponin activator. CK-586 is designed to reduce the hypercontractility associated with heart failure with preserved ejection fraction.
CYTOKINETICS, INCORPORATED 
