Cytokinetics Completes Enrollment for Phase 2 Trial Evaluating Reldesemtiv for ALS

Cytokinetics Completes Enrollment for Phase 2 Trial Evaluating Reldesemtiv for ALS
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Cytokinetics has completed patient enrollment in its Phase 2 trial to evaluate the safety and potential of reldesemtiv to improve muscle function in patients with amyotrophic lateral sclerosis (ALS), the company announced.

The trial (NCT03160898), called FORTITUDE-ALS, includes about 450 ALS patients in the U.S., Canada, Europe, and Australia who were randomized to receive 150, 300, or 450 mg of oral reldesemtiv or a placebo twice daily for 12 weeks.

The company expects to announce top-line results of the trial during the first half of 2019.

“Completion of enrollment in FORTITUDE-ALS marks an important step forward towards our advancing the first potential muscle-directed medicine for people living with ALS who desperately need new therapies that may increase muscle force, power and the time to muscle fatigue,” Robert I. Blum, president and CEO of Cytokinetics, said in a press release.

“We would like to thank all the dedicated investigators and clinical site coordinators who are working diligently to conduct this trial and to the people living with ALS and their caregivers who are participating,” he said.

After patients complete the treatment, researchers will evaluate changes in the percent predicted slow vital capacity — a measure of respiratory function and respiratory muscle control — compared with before the treatment.

They will also assess changes over time in muscle strength using several tests of speech production, handwriting abilities, and hand movement control.

Changes in the ALS Functional Rating Scale — as a measure of disease progression — as well as in patients’ quality of life will be determined. Incidence and severity of treatment-related adverse events will also be analyzed.

“There remains an urgent need in ALS to slow the decline of respiratory function, and to maintain stamina and muscle strength so that patients can sustain essential functionality for as long as possible,” said Jeremy Shefner, MD, PhD, lead investigator of the trial.

Reldesemtiv, formerly known as CK-2127107, is being developed by Cytokinetics in collaboration with Astellas Pharma.

This investigational compound is a next-generation fast skeletal muscle troponin activator designed to increase contractility of skeletal muscles. With its particular mode of action, reldesemtiv may represent a new therapeutic option for conditions characterized by skeletal muscle weakness and fatigue.

The U.S. Food and Drug Administration granted reldesemtiv orphan drug designation for spinal muscular atrophy (SMA), which also is associated with skeletal muscle degeneration.

Results from a Phase 2 trial (NCT02644668) in 70 patients with SMA demonstrated that reldesemtiv could increase muscle endurance and stamina consistent with its predicted mechanism of action.

“Fast skeletal muscle troponin activation may offer an important new approach to preserve strength in the presence of ongoing nerve loss and potentially complement current treatments for patients suffering from this dreadful disease,” said Shefner, who is also professor and chair of neurology at Barrow Neurological Institute, and professor and executive chair of neurology at the University of Arizona. “FORTITUDE-ALS is a large, international trial that was designed to answer key questions relating to this novel mechanism.”

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