Phase 3 study with mavacamten in non-obstructive HCM does not meet dual primary endpoints
The ODYSSEY-HCM trial did not meet its dual primary endpoints at week 48 in patients with symptomatic, non-obstructive hypertrophic cardiomyopathy (HCM).
The cardiac myosin inhibitor mavacamten failed to meet dual primary endpoints in the ODYSSEY-HCM trial in patients with symptomatic, non-obstructive hypertrophic cardiomyopathy (HCM). The dual primary endpoints were the changes in KCCQ 23-item Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2) from baseline to 48 weeks. There were no new safety signals observed.
ODYSSEY-HCM is a phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluates the effects of mavacamten versus placebo in 580 adults with symptomatic (NYHA class II or III) non-obstructive HCM.
The results from ODYSSEY-HCM shed light on the important pathobiological differences between non-obstructive and obstructive HCM. Mavacamten is indicated for the treatment of symptomatic, obstructive HCM in the US and Europe. “ODYSSEY-HCM indicates that we must consider new ways of thinking about potential treatment approaches for non-obstructive HCM,” said Milind Desai, MD, Vice Chair in the Heart, Vascular & Thoracic Institute and Director of the HCM Center, Cleveland Clinic in the press release.