The release of top-line data from clinical studies caused Edgewise Therapeutics, Inc. (NASDAQ: EWTX) shares to rise dramatically. During the Thursday session, EWTX stock price increased 54.69% to conclude at $29.50. The favorable results of a clinical study were the driving force behind that surge.
What Edgewise Therapeutics has shared?
Edgewise Therapeutics revealed key findings from the Phase 1 trial involving healthy subjects, as well as the single-dose component of the Phase 2 CIRRUS-HCM (obstructive hypertrophic cardiomyopathy) trial.
EDG-7500 is designed as an oral, selective cardiac sarcomere modulator aimed at reducing early contraction velocity and improving impaired cardiac relaxation linked to HCM. The Phase 1 single ascending dose (SAD) trial had doses ranging from 5 to 300 mg for participants. The multiple ascending dosage (MAD) phase involved the administration of doses ranging from 25 to 100 mg once day for a total of 14 days.
The absence of any alterations in clinical chemistry, electrocardiograms, or vital signs in either of the two trial segments demonstrated that EDG-7500 was well tolerated. Notably, the MAD portion demonstrated a half-life of approximately 30 hours, with steady-state concentrations achieved after about four days of dosing.
Efficacy in Patients with Obstructive HCM
Patients with obstructive HCM were given single doses of 50, 100, or 200 mg of EDG-7500 in the CIRRUS-HCM Part A experiment. There were notable decreases: for individuals taking the 100 and 200 mg dosages, there was a mean reduction in resting left ventricular outflow tract pressure gradient (LVOT-G) of 67% and a mean drop in provoked LVOT-G of 55%. Surprisingly, LVOT gradients below the 30 mmHg threshold were attained by 60% of patients receiving the larger dosages, and the medication had no negative effects on left ventricular ejection fraction (LVEF).
Future Directions
Edgewise Therapeutics is moving forward based on these promising results, initiating the 28-day segment of the CIRRUS-HCM trial in both obstructive and non-obstructive HCM patients. The company aims to further evaluate the tolerability, pharmacokinetics, and overall effects on cardiac metrics and biomarkers. Initial results from this segment are expected to be reported in the first quarter of 2025, with high hopes for EDG-7500 to advance the treatment landscape for HCM.
