US-based biopharmaceutical company Edgewise Therapeutics has dosed the first subject in the Phase II CIRRUS-HCM clinical trial of EDG-7500, a drug candidate designed to treat obstructive hypertrophic cardiomyopathy (HCM).
An oral, selective cardiac sarcomere modulator, EDG-7500 is claimed to slow down early contraction velocity and address the impaired cardiac relaxation linked to HCM.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The multicentre, open-label trial will be conducted across up to 20 clinical sites in the US, enrolling up to 30 adult patients with obstructive HCM.
It will assess EDG-7500’s safety, tolerability, pharmacokinetics (PK) and pharmacodynamics in these patients.
Trial subjects will receive a single oral dose of EDG-7500, with some potentially receiving multiple doses over a 28-day period in the study.
The trial is structured in two parts, with Part A assessing single doses of the therapy and Part B focusing on multiple doses orally over 28 days.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataEdgewise expects to report data from the single-dose arm of the trial, alongside results from a Phase I trial in healthy volunteers, in the third quarter of this year.
Plans are also in place to begin a 28-day trial in patients with obstructive and non-obstructive HCM in the second half of this year, followed by an open-label extension trial in the fourth quarter of the year.
Edgewise Therapeutics chief development officer Marc Semigran said: “Based on the strength of clinical and preclinical data to-date, we are advancing EDG-7500 into the Phase II CIRRUS-HCM trial in patients with obstructive HCM.
“EDG-7500 demonstrated potent left ventricular (LV) outflow tract gradient relief while maintaining overall normal LV contractility.
“Importantly, in preclinical models of non-obstructive HCM, both acute and chronic administration of EDG-7500 has also been observed to be associated with significant improvements in ventricular filling and diastolic function.”
Last year, Edgewise began dosing of healthy adults in a Phase I trial of EDG-7500 to treat HCM and other cardiac diastolic dysfunction diseases.
