Cytokinetics to halt Phase 3 ALS study due to lack of clinical benefit

Cytokinetics (NASDAQ:CYTK) announced Friday that the company intends to terminate its Phase 3 trial for its experimental therapy reldesemtiv against neurodegenerative disease amyotrophic lateral sclerosis (ALS) due to lack of treatment effect.

The COURAGE-ALS trial was designed to evaluate the skeletal muscle troponin activator against a placebo in approximately 555 patients with ALS.

The decision comes after the trial's Data Monitoring Committee (DMC) conducted its second planned interim analysis.

A review of unblinded study data indicated no evidence of effect in those who received reldesemtiv relative to placebo in terms of primary or key secondary endpoints.

As a result, the DMC has recommended discontinuing COURAGE-ALS due to futility, Cytokinetics (CYTK) said, adding that the company also plans to halt reldesemtiv treatment in all patients, including those in the open-label extension study, COURAGE-ALS OLE.

"We are extremely disappointed with this outcome and would like to thank the people with ALS, caregivers, investigators and clinical trial staff for their participation in COURAGE-ALS," Chief Executive Robert I. Blum remarked. Cytokinetics (CYTK) added ~5% pre-market in reaction to the news.

Seeking Alpha contributor Edmund Ingham argues that in the wake of the FDA rejection of its heart failure candidate omecamtiv mecarbil, the company is likely to focus its R&D efforts on aficamtem, a treatment targeted at hypertrophic cardiomyopathy.