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.
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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.
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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.
