Co. Reaches Major Milestone With Novel Drug
Research Report

Cytokinetics Inc. (CYTK:NASDAQ) began enrolling patients in the Phase 3 ACACIA-HCM clinical trial evaluating its drug aficamten in hypertrophic cardiomyopathy (HCM), reported H.C. Wainwright & Co. analyst Dr. Joseph Pantginis in a September 6 research note.

"ACACIA-HCM stands as a significant milestone in the development of aficamten," Pantginis wrote. "This development is particularly exciting, as it brings Cytokinetics one step closer to the anticipated US$50 million milestone payment from Royalty Pharma upon the initiation of patient dosing in ACACIA-HCM."

Attractive Return, Buy Rating

Accordingly, H.C. Wainwright reiterated its target price on Cytokinetics of US$49 per share, noted Pantginis. The biopharma is currently trading at about US$35.16 per share in comparison.

The price difference implies a compelling return for investors of 39%.

California-based Cytokinetics remains a Buy.

Aficamten vs. Placebo

Pantginis reviewed the specifics of the ACACIA-HCM study, an assessment comparing aficamten to placebo on cardiac endpoints in adults with symptomatic nonobstructive hypertrophic cardiomyopathy. Aficamten is Cytokinetics' cardiac myosin inhibitor.

The biopharma aims to enroll about 420 patients for this multicenter, double-blind, randomized study. All patients will start out receiving aficamten 5 milligrams (5 mg) daily or a placebo. After weeks two, four, and six, patients with a left ventricular ejection fraction (LVEF) of 60% or higher may have their dose increased to 10, 15, or 20 mg. Otherwise, patients will remain on their current dose or even have it lowered if their LVEF is less than 50%.

All patients will be assessed at week 36 for the primary endpoint of the Kansas City Cardiomyopathy Questionnaire, Pantginis relayed. After, patients will continue being treated for up to 72 weeks, during which period additional analyses will be done.

"We are excited about the path ahead and eagerly await future data readouts and valuable insights from the Phase 3 study," Pantginis commented.

Aficamten vs. Metoprolol

In patients with obstructive hypertrophic cardiomyopathy who are symptomatic (versus nonobstructive in ACACIA-HCM), Cytokinetics just started a separate Phase 3 trial called MAPLE-HCM. In this study, aficamten will be compared to the beta blocker, metoprolol, in this patient population in which beta blockers are currently the standard of care, Pantginis reported.

"MAPLE-HCM has the ability to demonstrate aficamten's potential as first-line therapy in patients with hypertrophic cardiomyopathy," the analyst added.

Target enrollment for the trial is 170 patients. On a one-to-one basis, patients will be randomized to either aficamten or metoprolol. Patients will receive up to four escalating doses of aficamten (5, 10, 15, or 20 mg, once daily) or metoprolol (50, 100, 150, or 200 mg, once daily), depending on echocardiographic results at weeks two, four, and six.

The trial's primary endpoint is a change in pulmonary venous oxygen tension (pVO2) from baseline to week 24 as measured by cardiopulmonary exercise testing.

Patients who complete MAPLE-HCM may participate in the ongoing FOREST-HCM trial assessing the long-term (48-week) efficacy of aficamten.

Tackling Cardiac Hypercontractility

In other news, relayed Pantginis, dosing has started in the Phase 1 trial evaluating Cytokinetics' small molecule cardiac myosin inhibitor, CK-4021586. The biopharma intends for the drug to reduce hypercontractility linked to heart failure with preserved ejection fraction.

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Disclosures for H.C. Wainwright & Co., Cytokinetics Inc., September 6, 2023

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