As Cytokinetics ALS drug fails Phase III trial, attention turns to aficamten

US muscle biology specialist Cytokinetics (Nasdaq: CYTK) is set to wind down the Phase III trial of its amyotrophic lateral sclerosis (ALS) pipeline drug, reldesemtiv, as there is no evidence of an effect compared to placebo on primary or secondary endpoints.

This comes after the pharma company announced that the US Food and Drug Administration (FDA) had rejected its heart failure drug, omecamtiv. The failure of reldesemtiv and omecamtiv places additional pressure on the success of Cytokinetics’s final Phase III pipeline candidate, aficamten - a drug that is project to generate as much as $1.37 billion by 2031, according to data and analytics company GlobalData.

Aficamten is a myosin inhibitor targeting patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM). The drug received Breakthrough Therapy designation by the FDA in December 2021 and its Phase III trial, titled SEQUOIA-HCM, has an estimated completion date of September 2023.