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MyoKardia announced positive results from the EXPLORER-HCM clinical trial, revealing that mavacamten significantly reduced cardiac hypertrophy in patients with hypertrophic cardiomyopathy (HCM). The study demonstrated a favorable impact on cardiac structure without compromising function over 30 weeks. Key findings included a statistically significant decrease in left ventricular mass index (p<0.0001) and other important cardiac parameters. Mavacamten showed a well-tolerated safety profile, with plans for a New Drug Application submission to the FDA in early 2021.
MyoKardia presented significant clinical findings on Mavacamten at the AHA Scientific Sessions 2020, highlighting its effectiveness in treating obstructive hypertrophic cardiomyopathy (HCM). The Phase 3 EXPLORER-HCM trial revealed that after 30 weeks, Mavacamten therapy significantly reduced left ventricular mass and improved diastolic function. Moreover, more patients showed resolution of mitral valve anterior motion and regurgitation compared to placebo. A Phase 2 trial, MAVERICK-HCM, indicated physical activity correlated with clinical HCM severity markers. These results suggest Mavacamten positively affects cardiac structure and function.
MyoKardia has partnered with the American College of Cardiology to launch a nationwide registry for hypertrophic cardiomyopathy, named DISCOVER-HCM. This registry, utilizing the existing PINNACLE Cardiovascular Registry, aims to evaluate the long-term safety and effectiveness of mavacamten in patients with symptomatic, obstructive hypertrophic cardiomyopathy. The study, expected to enroll patients in summer 2021, focuses on gathering real-world data and patient perspectives on HCM treatment outcomes, contributing to the understanding of this serious condition.
MyoKardia reported its third-quarter financial results, highlighting significant clinical advancements in its therapies. The company demonstrated notable progress with mavacamten in treating hypertrophic cardiomyopathy, achieving positive outcomes in its Phase 3 study, and initiated a Phase 2 trial for danicamtiv in genetic dilated cardiomyopathy. Additionally, a strategic partnership with LianBio aims to enhance mavacamten's market presence in China. MyoKardia is set for an acquisition by Bristol-Myers Squibb for $13.1 billion, expected to finalize in Q4 2020.
MyoKardia announced the 2020 MyoSeeds™ Research Grant Program recipients, awarding $250,000 to each of the three selected researchers focusing on cardiomyopathy. The awardees are Dr. Ju Chen from UC San Diego, Dr. Da-Zhi Wang from Boston Children's Hospital, and Dr. Jorge Alegre-Cebollada from the Spanish National Center for Cardiology Research. This initiative aims to enhance understanding of the biological mechanisms behind cardiovascular diseases, promoting advancements in research and potential treatment strategies.
MyoKardia announced the upcoming presentation of pivotal data on mavacamten, a therapeutic for hypertrophic cardiomyopathy, at the American Heart Association’s Scientific Sessions 2020. Noteworthy abstracts will discuss echocardiographic and cardiac magnetic resonance imaging findings from the EXPLORER-HCM trial, addressing cardiac structure and function changes. Key presentations include the oral session on November 15 at 3:30 p.m. CT. This event highlights MyoKardia's commitment to innovative science in cardiovascular disease.
MyoKardia announced the dosing of the first patient in a Phase 2 clinical trial for danicamtiv, aimed at treating primary dilated cardiomyopathy (DCM) caused by genetic mutations. Danicamtiv, an oral cardiac myosin activator, enhances heart contractility without impairing relaxation. This trial will enroll up to 24 patients with genetic variants in MYH7 or titin, focusing on safety and preliminary efficacy. Topline data is expected in the second half of 2021. DCM affects 250,000 to 500,000 people in the U.S., with significant mortality risks due to limited treatment options.
MyoKardia announced the presentation of pivotal 30-week results from the Phase 3 EXPLORER-HCM clinical trial for mavacamten, treating symptomatic obstructive hypertrophic cardiomyopathy (HCM). Results, presented at ESC Congress 2020 and published in The Lancet, demonstrated significant improvements in symptoms and quality of life, meeting both primary and secondary endpoints. Mavacamten produced an 80% reduction in cardiac biomarkers like NT-proBNP, indicating substantial cardiac wall stress relief. The therapy displayed a favorable safety profile with 97% treatment completion. A New Drug Application is planned for submission in early 2021.
MyoKardia has entered a strategic partnership with LianBio to develop and commercialize mavacamten, targeting hypertrophic cardiomyopathy (HCM) in China. This collaboration allows MyoKardia to maintain influence over the program while benefiting from LianBio's regional expertise. MyoKardia will receive an upfront payment of $40 million and potential milestone payments up to $147.5 million. The partnership aims to address significant unmet medical needs for HCM patients in Asia, where the disease affects over one million individuals.
On August 5, 2020, MyoKardia announced that Jake Bauer, Chief Business Officer, will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on August 11, 2020, at 3:30 p.m. ET. The presentation will be available via webcast on the Investors section of MyoKardia’s website, with a replay accessible for 90 days post-conference.
MyoKardia focuses on developing targeted therapies for serious cardiovascular diseases, utilizing a precision medicine approach. Their key clinical-stage therapeutics include mavacamten, danicamtiv, and MYK-224.
