Cytokinetics heart disease drug improves disease symptoms in late-stage study

By Sneha S K

May 5 (Reuters) – Cytokinetics said on Tuesday its experimental heart disease drug significantly improved symptoms of a genetic heart condition in a late-stage trial, sending its shares up 21%.

The company was testing the drug, chemically known as aficamten, in patients with non-obstructive hypertrophic cardiomyopathy (nHCM), where the heart muscle thickens without blocking blood flow.

The drug, under the brand name Myqorzo, was approved last year for patients with obstructive hypertrophic cardiomyopathy, a condition in which the heart muscle becomes abnormally thick and forms an obstruction that can reduce blood flow to the body.

“Given the unmet need in nHCM, this represents an inflection point in what the treatment of nHCM could look like for these patients,” said CEO Robert Blum on a conference call.

In the 516-person study, the drug helped improve heart failure symptoms such as physical limitations, and quality of life compared with placebo, as measured by a patient‑reported questionnaire through 36 weeks.

“There will be debate on the headline effect sizes, but overall we think the big picture is favorable,” said Stifel analyst James Condulis.

The drug also showed significant improvements in exercise capacity and heart function, meeting secondary goals of the study.

“Today’s results support Myqorzo approval in nHCM, which could also solidify its status at the preferred HCM therapy over Camzyos from Bristol Myers Squibb,” said Truist analyst Srikripa Devarakonda.

Bristol’s Camzyos did not significantly improve functional capacity and symptoms in patients with non-obstructive form of hypertrophic cardiomyopathy in a late-stage study last year.

Cytokinetics said there were no new safety signals identified.

The company plans to share additional data and will discuss the results with the U.S. FDA and other regulatory authorities.

Shares of Edgewise Therapeutics , which is developing an oral drug to treat hypertrophic cardiomyopathy, were up 23% as the results establish that this broader class of drugs “works” in nHCM, analysts said.

(Reporting by Sneha S K in Bengaluru; Editing by Devika Syamnath)