Edgewise Therapeutics has reported phase 2 data on its cardiomyopathy prospect, keeping the biotech on track to start pivotal development of a would-be challenger to Bristol Myers Squibb and Cytokinetics.
BMS’ Camzyos and Cytokinetics’ Myqorzo are approved by the FDA as treatments for obstructive hypertrophic cardiomyopathy (oHCM), one of the two indications Edgewise targeted in the phase 2 trial. Cytokinetics reported a phase 3 win in Edgewise’s other target indication, nonobstructive HCM (nHCM) last month. Facing the prospect of being second and third to market in the indications, Edgewise needs differentiated data to flourish.
Part D of the phase 2 CIRRUS-HCM trial provided a look at how Edgewise’s EDG-7500, a selective cardiac sarcomere modulator, is shaping up versus the competition. Investors were initially unsure how to view the data, sending Edgewise’s shares yo-yoing premarket before the stock opened down 10% and then regained some ground in early trading.
The drop may reflect comparisons to Edgewise’s previously released four-week data, which were comparable to longer-term Camzyos and Myqorzo results. At week 4, Edgewise saw an up to 22-point improvement on the Kansas City Cardiomyopathy Questionnaire (KCCQ) in nHCM, easily beating its rivals on cross-trial comparisons.
The KCCQ improvement slipped to 13 points in Edgewise’s newly released 12-week data, narrowing the gap.
With Edgewise sharing data on multiple endpoints across two populations, the update provides room for a range of comparisons of the efficacy of EDG-7500, Camzyos and Myqorzo. Safety and tolerability could be as important, though, with the approved drugs’ boxed warnings and requirement for ejection fraction monitoring necessitating echocardiograms and patient monitoring.
“That reality caps the number of physicians that can prescribe these drugs,” Edgewise CEO Kevin Koch, Ph.D., said on an analyst call to discuss the data. “The real opportunity in hypertrophic cardiomyopathy is to move our drug, ‘7500, into the community cardiologists who do not want to do multiple echos.”
Edgewise’s phase 2 data showed no reductions in left ventricular ejection fraction (LVEF) below 50%. The potential for rival drugs to lower LVEF informs their dose titration and patient monitoring requirements. Edgewise reported two new-onset atrial fibrillation (afib) events, both deemed unrelated to study drug by the investigator. Afib rates were higher in the company’s week 4 data.