Cytokinetics Release CK-2127107 Phase II Clinical Trial Data
20 June 2018
Cytokinetics presented data at the 2018 Cure SMA conference from the Phase II clinical trial with SMA patients of its drug CK-2127107, which has been renamed reldesemtiv.
Reldesemtiv can increase the force generated by skeletal muscles, as well as delay the onset and extent of muscle fatigue. Consequently, Cytokinetics is testing reldesemtiv in diseases causing neuromuscular dysfunction, weakness and fatigue, to see whether it can improve muscle function and physical performance.
In collaboration with Astellas, Cytokinetics initiated a phase II clinical trial of reldesemtiv with SMA patients in early 2016 (click here for more information).
The trial, which is being conducted in North America, is double-blind, randomised, and placebo-controlled, meaning that patients were randomly allocated to either a treatment or placebo group, and that this was concealed from patients and the people administering the treatment.
Prof. John W. Day presented the latest findings from the trial, indicating that the study met its primary and secondary purposes of assessing the pharmacodynamics, pharmacokinetics, safety, and tolerability of multiple oral doses of the drug in ambulatory and non-ambulatory patients with SMA Types 2, 3 or 4 aged 12 years and older.
Tested at two different concentrations of 150 mg and 450 mg twice daily for eight weeks, reldesemtiv caused no adverse effects beyond what was seen in the patients receiving placebo.
In addition, the trial provided preliminary data indicating that reldesemtiv delayed muscle fatigue compared to SMA patient baseline recordings in a dose- and concentration-dependent manner. This was shown using a six minute walk test in ambulatory patients and Maximal Expiratory Pressure (MEP) testing, which measures the strength of muscles involved in breathing.
However, no meaningful improvements compared to placebo were reported in other patient tests (including the Hammersmith Functional Motor Score – Extended, Revised Upper Limb Module, Timed Up-and-Go, and Forced Vital compacity).
These latest trial data indicate that reldesemtiv may provide clinically meaningful benefits to SMA patients, and that it could be used in combination with SMN-dependent therapies, such as Spinraza, to provide additional improvement.
Cytokinetics and Astellas now intend to discuss the data with regulatory authorities to determine future directions for reldesemtiv.