CINCINNATI (June 24, 2024) – The Christ Hospital Health Network completed its first dosage of a patient for a clinical trial treating hypertrophic cardiomyopathy (HCM), a heart condition that causes the heart’s walls to thicken and can lead to heart failure. The Christ Hospital is the second location to take part nationally of the Phase 2 CIRRUS-HCM trial of EDG-7500 and only in the greater Midwest.
This clinical trial is specifically designed to slow early contraction and address impaired cardiac relaxation associated with HCM. This Phase will assess safety, tolerability in patients with obstructive HCM. Part A of the trial will evaluate single doses while Part B will evaluate multiple oral doses of EDG-7500 over 28 days.
“This clinical trial has the chance to be a gamechanger in how we treat those with hypertrophic cardiomyopathy,” said Ankit Bhatia, MD, Principal Investigator for the clinical trial and Co-Director of The Christ Hospital Hypertrophic Cardiomyopathy Center of Excellence. “HCM occurs in about 1 in 500 people and can affect both children and adults. The condition thickens and stiffens your heart muscle and that stiffness can lead to dizziness, chest pain, shortness of breath that can significantly limit quality of life. This novel medication has the opportunity to be a breakthrough in how we care for HCM by directly acting to reduce heart stiffness with goal of symptomatic improvement.”
“Based on the strength of clinical and preclinical data to-date, we are advancing EDG-7500 into the Phase 2 CIRRUS-HCM trial in patients with obstructive HCM,” said Marc Semigran, M.D., Chief Development Officer, Edgewise Therapeutics that is running the clinical trial. “We are encouraged by the effects of EDG-7500 observed in a translatable preclinical disease model of 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.”
The Hypertrophic Cardiomyopathy Center at The Christ Hospital is the region’s first, dedicated HCM Center, as well as the first to be designated by the Hypertrophic Cardiomyopathy Association as an HCM Center of Excellence.
CIRRUS-HCM is a multi-center, two-part, open-label trial of EDG-7500 in patients with obstructive HCM at up to 20 clinical sites in the U.S. The trial will evaluate the safety, tolerability in up to 30 adults with obstructive HCM across the U.S. Participants enrolled in this trial will receive EDG-7500 as a single oral dose and may then receive multiple oral doses over 28 days. To learn more about this trial (NCT06347159), go to clinicaltrials.gov.
About The Christ Hospital Health Network
The Christ Hospital Health Network consists of an acute care hospital located in Mt. Auburn, a remote hospital location in Liberty Township, five ambulatory outpatient centers and dozens of medical offices throughout the region. For more than 130 years, The Christ Hospital has provided compassionate care to those it serves. Made up for more than 1,300 physicians and more than 6,500 team members, our mission is to improve the health of our community by providing exceptional outcomes in an affordable way. The Network was recognized by U.S. News & World Report as the #1 hospital in the Cincinnati Region and named to Newsweek’s World’s Best Hospitals list in 2024. It is also a Press Ganey Guardian of Excellence Award recipient, which recognizes top-performing healthcare organizations that achieve the 95th percentile or above of performance in patient experience.