Edgewise Therapeutics Stock Shoots Higher On Promising Early Results For Thickened Heart Treatment

On Thursday, Edgewise Therapeutics Inc. EWTX released announced topline data of EDG-7500 from the Phase 1 trial in healthy subjects and the single-dose arm of the Phase 2 CIRRUS-HCM trial for obstructive hypertrophic cardiomyopathy.

Obstructive hypertrophic cardiomyopathy is a heart condition that occurs when the wall between the left and right ventricles of the heart thickens, blocking blood flow from the left ventricle to the body’s main artery. 

In the Phase 1 single ascending dose (SAD) trial (n=48), healthy subjects received single doses of EDG-7500, ranging from 5 to 300 mg.

In the trial’s multiple ascending dose (MAD) portion (n=24), healthy subjects received 25 to 100 mg once daily for 14 days.

EDG-7500 was well tolerated in both the SAD and MAD; there were no clinically meaningful changes or trends in vital signs, clinical chemistry, hematology, or electrocardiograms.

There were no meaningful changes in left ventricular ejection fraction for all SAD and MAD subjects across a broad range of EDG-7500 exposures.

The ejection fraction is an indicator of heart strength. It measures the amount of oxygen-rich blood pumped out to the body with each heartbeat.

In the MAD, a half-life of approximately 30 hours was observed, and a steady state was achieved approximately 4 days after the start of once-daily dosing.

Generally, dose-proportional increases in exposure were observed in both SAD and MAD.

In CIRRUS-HCM Part A, patients with obstructive HCM received a single dose of 50, 100 or 200 mg of EDG-7500.

A 67% mean reduction in resting LVOT pressure gradient (LVOT-G, obstruction of blood flow) and a 55% mean reduction in provokable (Valsalva) LVOT-G were observed in patients receiving the 100 and 200 mg single doses.

LVOT gradients less than 30 mmHg at rest and less than 50 mmHg with Valsalva were observed in 60% of patients receiving 100 or 200 mg of EDG-7500.

Gradient reduction was achieved without a meaningful change in LVEF.

Treatment with a single dose of EDG-7500 also led to a 64% mean reduction in NT-proBNP, a key biomarker of heart failure, in the 200 mg cohort.

Across the Phase 1 and CIRRUS-HCM trials, no subjects experienced a reduction in LVEF (left ventricular ejection fraction) below 50%, even with a wide range of EDG-7500 exposures.

Price Action: EWTX stock is up 39.3% at $26.58 at last check Thursday.

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