Edgewise Therapeutics has announced positive top-line findings from two clinical trials where its EDG-7500 showed benefit as a potential treatment for obstructive hypertrophic cardiomyopathy (HCM).

The data comprise results from a Phase I trial in healthy subjects and the single-dose arm of the Phase II CIRRUS-HCM trial.

An oral, selective modulator, EDG-7500 is designed to address cardiac relaxation issues associated with HCM.

In the placebo-controlled Phase I single ascending dose (SAD) trial, healthy subjects received single doses of EDG-7500, ranging from 5mg to 300mg.

The multiple ascending dose (MAD) portion saw subjects receive 25 to 100mg once daily for 14 days.

In the trial, EDG-7500 was found to be well-tolerated without any significant changes in vital signs, clinical chemistry, haematology, or electrocardiograms.

No meaningful changes in left ventricular ejection fraction (LVEF) were reported for all SAD and MAD subjects across a broad range of EDG-7500 exposures.

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

Edgewise dosed the first subject in the Phase II CIRRUS-HCM trial of EDG-7500 to treat obstructive HCM, in May this year.

In the trial, a 67% mean reduction in resting left ventricular outflow tract pressure gradient (LVOT-G) and a 55% mean decline in provokable LVOT-G were reported in patients who were given the 100mg and 200mg treatment doses.

Furthermore, 60% of the subjects attained LVOT gradients below 30mmHg at rest and below 50mmHg with Valsalva after receiving 100mg or 200mg of EDG-7500.

Significantly, the gradient reduction was attained without causing a meaningful change in LVEF.

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

Edgewise Therapeutics president and CEO Kevin Koch said: “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.

“We expect to report initial 28-day data in the first quarter of 2025.”

"Edgewise’s EDG-7500 shows benefit in two obstructive HCM trials" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.

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