MyoKardia Presents Cardiac Imaging Data from 30-Week EXPLORER-HCM Study of Mavacamten

EXPLORER-HCM Cardiac Imaging Data Presented at AHA 2020 Scientific Session with Simultaneous Publication in Circulation
Mavacamten Treatment Resulted in Favorable Effect on Cardiac Structure -- Significantly Reduced Hypertrophy in Patients with Hypertrophic CardiomyopathyBRISBANE, Calif., Nov. 15, 2020 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq: MYOK) announced results from its cardiac magnetic resonance imaging (CMR) substudy of mavacamten for the potential treatment of hypertrophic cardiomyopathy (HCM) showing that 30-week treatment with mavacamten has a favorable effect on cardiac structure, while maintaining contractile function within the normal range. These data were shared today in an oral presentation titled, a??Mavacamten Favorably Impacts Cardiac Structure in Obstructive Hypertrophic Cardiomyopathy: EXPLORER-HCM CMR substudya?? (Oral Session 18654), at the American Heart Associationa??s Scientific Sessions 2020 during the High Profile Clinical Science in CVD session. Data from the EXPLORER-HCM CMR substudy were also published simultaneously in Circulation.The CMR substudy was conducted as part of MyoKardiaa??s pivotal Phase 3 EXPLORER-HCM clinical trial in patients with symptomatic, obstructive HCM to assess the impact of once-daily treatment with mavacamten on parameters of cardiac structure and function. Thirty-five patients were enrolled in the CMR substudy and randomized to mavacamten (n=17) or placebo (n=18) and had valid CMR assessments at day 1 and week 30 (end of treatment) which were analyzed centrally in a blinded manner. Statistically significant changes from baseline to Week 30 were observed in the mavacamten group vs. placebo for the primary endpoint of left ventricular mass index (p<0.0001), as well as exploratory endpoints of absolute intracellular myocardial mass index, maximum wall thickness, and maximum left atrial volume index (all p<0.001 for the difference from placebo). From baseline to Week 30, there was no worsening in myocardial fibrosis, another common characteristic of HCM.a??Hypertrophic cardiomyopathy is defined by the thickening of the heart muscle, so to see favorable remodeling of the heart indicating a lessening of hypertrophy within 30-weeks of treatment is a highly encouraging finding for the many patients struggling with HCM,a?? said Sara Saberi, M.D., Assistant Professor in the Division of Cardiovascular Medicine and member of the Inherited Cardiomyopathy Program at the University of Michigan Medical School, and lead author on the study. a??The CMR substudy is the first randomized, controlled clinical trial of HCM patients to show that a once-daily oral therapeutic agent can reduce left ventricular wall thickness and mass, and positively impact several other parameters of cardiac structure and function. Left ventricular hypertrophy and left atrial volumes in particular are predictive of poor prognosis in HCM patients, so it will be exciting to see how mavacamten impacts cardiac function and disease progression as we continue to follow patients over time.a??A A 
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