Edgewise Therapeutics Reports Promising Phase 2 Results for Potential Camzyos Rival in Hypertrophic Cardiomyopathy

Edgewise Therapeutics has announced positive results from its phase 2 Cirrus-HCM trial evaluating EDG-7500, a cardiac sarcomere modulator, in patients with hypertrophic cardiomyopathy (HCM). The study demonstrated significant reductions in heart valve pressure and other key metrics, positioning EDG-7500 as a potential competitor to Bristol Myers Squibb's Camzyos and Cytokinetics' aficamten.

Significant Pressure Reductions and Biomarker Improvements

The open-label phase 2 trial assessed 50-mg and 100-mg daily doses of EDG-7500 over four weeks in patients with both obstructive and nonobstructive HCM. In patients with obstructive HCM, the 100-mg dose resulted in a mean reduction from baseline of 71% in left ventricular outflow tract gradient (LVOT-G) at rest and 58% after forced exhalation. These reductions were achieved without meaningful changes in left ventricular ejection fraction (LVEF), indicating preserved pumping function of the heart.

Additionally, the 100-mg cohort exhibited a 62% mean reduction from baseline in NT-proBNP, a biomarker of heart failure, in obstructive HCM patients. For those with nonobstructive HCM, a 42% reduction in NT-proBNP was observed.

Safety Profile and Competitive Landscape

While the trial showed promising efficacy, two patients experienced serious adverse events of atrial fibrillation (AF) requiring cardioversion. Edgewise noted that the AF rates were comparable to those seen in phase 2 trials of cardiac myosin inhibitors. The most frequently reported adverse events were dizziness, upper respiratory tract infection, and AF, with most events considered mild to moderate in severity.

EDG-7500 is poised to enter a competitive market, with Bristol Myers Squibb's Camzyos already established and Cytokinetics' aficamten under FDA review with a PDUFA date of September 26. Notably, Camzyos carries an FDA black box warning for heart failure, highlighting the importance of EDG-7500's safety profile in its potential market positioning.

Future Development and Financial Moves

Edgewise CEO Kevin Koch expressed optimism about EDG-7500's potential, stating, "We believe EDG-7500, which delivered clinically meaningful results without causing systolic dysfunction, has the potential to be a significant advancement for patients with HCM and the clinicians who care for them."

The company is currently optimizing its dosing strategy in part D of the CIRRUS-HCM trial, with initial data expected in the second half of 2025. Edgewise plans to launch a phase 3 trial in the first half of 2026.

Concurrent with the trial results announcement, Edgewise disclosed a $200 million underwritten offering of common stock. The funds are earmarked for supporting the potential launch of sevasemten, its Becker muscular dystrophy drug, and the planned phase 3 trial of EDG-7500.