Cytokinetics, a San Francisco-based biotechnology company, 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 the 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 GlobalData, a leading data and analytics company.

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.

HCM is one of several subtypes of cardiomyopathy, a term that refers to a heterogenous collection of diseases characterized by impaired heart muscle. Subtypes include HCM, dilated cardiomyopathy (DCM), arrhythmogenic cardiomyopathy (ACM) and restrictive cardiomyopathy (RCM).

Aficamten is one of two Phase III pipeline therapies for cardiomyopathies; the other, caficrestat, is in clinical trial development under Applied Therapeutics, and is also targeting patients with myocardial infarction, COVID-19, congestive heart failure, diabetic peripheral neuropathy, and pulmonary inflammation.

Sarah Bundra, Pharma Analyst at GlobalData, comments: “If aficamten is successful in coming to market, it will be second to Bristol Myers Squibb’s Camzyos (mavacamten), a first-in-class myosin inhibitor. The drug received FDA approval in October 2022, and currently enjoys its position as the only marketed cardiomyopathies therapy with that unique mechanism of action.

“In order to find success, aficamten will need to have a superior efficacy or safety profile compared to Camzyos to combat its disadvantage of being second to market.”