World News: 13:30 GMT Tuesday 28th May 2019. [MyoKardia, Inc. via Globe Newswire via SPi World News]
SOUTH SAN FRANCISCO, Calif. and ATHENS, Greece, May 28, 2019 (GLOBE NEWSWIRE) -- MyoKardia, Inc., (Nasdaq: MYOK), presented data today at the European Society of Cardiology Heart Failure Congress from its Phase 1a single-ascending dose study of MYK-491 in healthy volunteers. MYK-491 is MyoKardia’s most advanced activator molecule, designed to increase contractility of the heart (systolic function) with minimal effects on myocardial relaxation (diastolic function).
First-in-human data from the Phase 1a clinical trial of MYK-491 in healthy volunteers showed the drug to be well tolerated. MYK-491 increased cardiac contractility by 5-20 percent across multiple echocardiographic parameters at higher drug concentrations, with minimal impact on diastolic function. MYK-491 is currently being studied in a Phase 2a multiple-ascending dose clinical trial for the treatment of patients with systolic heart failure, in which the heart is unable to contract sufficiently to meet the demands of the body.
“In developing MYK-491, we set out to target the underlying heart muscle proteins to increase contraction, with minimal impact on the heart’s ability to relax and fill with oxygenated blood between beats. Data from our Phase 1a study in healthy volunteers demonstrate that MYK-491 is achieving this desired effect, and these results have been confirmed by data from our Phase 1b study in patients with stable heart failure,” said June Lee, M.D., Executive Vice President, Chief Development Officer. “We are now looking forward to assessing MYK-491’s safety and activity in patients when administered over several days in our multiple-ascending dose study. The data from our ongoing proof-of-concept Phase 2a trial, combined with translational research efforts, will inform our late-stage development plans, and we look forward to reporting those results later this year.”
MYK-491 was generally well tolerated with no dose-limiting toxicities observed. Transient and spontaneously resolving arrhythmias were reported. The most common adverse event (AE) reported was headache, and there was no trend for increased AE frequency associated with higher dose concentrations. Pharmacokinetic results indicated MYK-491 may be amenable to once- or twice-daily dosing.
Dose- and concentration-dependent increases in stroke volume (SV) and other indicators of enhanced systolic function were observed, including increases in left ventricular fractional shortening (FS) and ejection fraction (EF) as well as decreases in end-systolic left ventricular dimensions. At the highest dose cohort, a modest prolongation of systolic ejection time (SET) and no discernible impact on relaxation and diastolic function (as measured by mitral annular and peak filling velocities during diastole) were observed.
These data were reported today by Jean-Francois Tamby, M.D., Vice President, Clinical Sciences, MyoKardia at the European Society of Cardiology Heart Failure Congress in a poster titled, “MYK-491, a Novel Cardiac Myosin Activator, Increases Cardiac Contractility in Healthy Volunteers” (Abstract 60668). MyoKardia previously detailed results from the Phase 1a study of MYK-491 at its October 2018 R&D Day.
MyoKardia’s mission is to change the world for patients with serious cardiovascular disease through bold and innovative science.
Senior Director, Corporate Communications and Investor Relations
Hannah Deresiewicz (investors)
Stern Investor Relations, Inc.
Steven Cooper (media)
Globe Newswire: 13:30 GMT Tuesday 28th May 2019
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