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Cytokinetics' Experimental Heart Disease Drug Shows Promising Results in Late-Stage Study

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Ayanna Amadi
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Cytokinetics' Experimental Heart Disease Drug Shows Promising Results in Late-Stage Study

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Cytokinetics, a pioneering biopharmaceutical company, has recently announced that its experimental heart disease drug, aficamten, has successfully met the main goal of a late-stage study for treating hypertrophic cardiomyopathy (HCM). This success has positioned Cytokinetics as a potential competitor to Bristol Myers Squibb, which has a similar treatment.

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Groundbreaking Results from the SEQUOIA HCM Phase 3 Clinical Trial

The SEQUOIA HCM Phase 3 clinical trial of aficamten demonstrated positive results, with the oral drug significantly improving the exercise capacity in patients compared to a placebo. The treatment effect with aficamten was consistent across all prespecified subgroups, and statistically significant and clinically meaningful improvements were also observed in all 10 prespecified secondary endpoints. Moreover, aficamten was well-tolerated with an adverse event profile comparable to a placebo, with no instances of worsening heart failure or treatment interruptions due to low LVEF.

Breakthrough Therapy Designation

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In recognition of the potential of aficamten, both the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) in China have awarded it Breakthrough Therapy Designation for the treatment of symptomatic obstructive HCM. The full results from SEQUOIA HCM will be presented at an upcoming medical conference.

Implication for Patients with HCM

Hypertrophic cardiomyopathy is a genetic disease where the heart muscle becomes abnormally thick, interfering with the heart's ability to pump blood. Aficamten, a once-daily pill, could offer a new treatment option for patients who are currently underserved by existing therapies. The drug not only improved exercise capacity but also enhanced oxygen uptake in patients, compared to those getting a placebo.

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Future Plans and Market Implications

Cytokinetics plans to submit the drug for clearance in the second half of 2024. If approved by U.S. regulators, aficamten would compete with Bristol Myers Squibb Co.’s Camzyos, which was cleared last year as a treatment for obstructive HCM. This success has led to significant speculation about a potential takeover of Cytokinetics, with potential interest from major pharmaceutical companies such as Novartis AG and AstraZeneca Plc. The company's shares have seen a significant rise, with an increase of over 40% in premarket trading and as much as 83% at the New York market open.

Aficamten's Potential in Heart Disease Treatment

The successful results of the late-stage study of aficamten are a significant milestone in heart disease treatment. It not only validates the effectiveness of aficamten in improving exercise capacity in patients with HCM but also its potential use in other heart conditions. The success of Cytokinetics' drug has provided a much-needed boost to the company, especially after experiencing previous setbacks. Looking ahead, the company plans to discuss the results with the FDA and file for approval in 2024, heralding a potential new treatment option for patients with heart disease.

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