Edgewise Therapeutics' hypertrophic cardiomyopathy (HCM) asset has started off with a bang after early safety data sent the company’s shares soaring.
Edgewise tested its drug, dubbed EDG-7500, separately in healthy subjects and in patients with obstructive HCM. The phase 1 data in healthy subjects showed that the cardiac sarcomere modulator was well tolerated, while a phase 2 study noted an effect across several heart health measures. Specifically, treatment with one dose of 200 mg of EDG-7500 in first part of the CIRRUS-HCM phase 2 trial led to a 64% mean reduction in NT-proBNP, which is a key biomarker of heart failure.
Importantly, none of the participants across the two trials had a left ventricle ejection fraction (LVEF) fraction below 50%, Edgewise reported, meaning that the left ventricle of the heart was still pumping a normal amount of blood. Normal LVEF falls between 50% and 70%, while below 40% is considered reduced and can be a sign of heart disease.
For HCM patients, the drug proved robust left ventricle outflow tract gradient reductions without meaningful changes in LVEF, a key measure of the disease.
Based on the data, the company has initiated the 28-day part of its CIRRUS-HCM study in patients with obstructive and non-obstructive HCM, Chief Development Officer Marc Semigran, M.D., noted in the company’s Sept. 19 release.
EDG-7500 is designed to slow early contraction velocity and address the impaired cardiac relaxation that is associated with HCM.
“We believe our innovative approach, where we have observed gradient relief without reductions in LVEF, has the potential to be a valuable advancement in the treatment of obstructive HCM,” CEO Kevin Koch, Ph.D., added in the release. “We expect to report initial 28-day data in the first quarter of 2025.”
The early data had pushed the company’s shares up 55% to $29.50 by the close of trading Thursday. Should EDG-7500 eventually make it to market, the drug will find itself competing with Bristol Myers Squibb’s established Camzyos and Cytokinetics’ candidate aficamten, which is being submitted to the FDA this quarter.
As for how EDG-7500 will shake things up, analysts point out that it’s likely too early to tell.
While the new Edgewise data don't "give much of a reason" to undermine Cytokinetics’ offering, especially considering aficamten is well ahead in the race to market, EDG-7500 “looks similar” to Cytokinetics’ phase 2 data, analysts at Mizuho Securities wrote in a note to clients. However, it is difficult to compare with the limited efficacy data available so far on Edgewise’s end, they added.