On May 9, 2022, LianBio announced the completion of a Phase I pharmacokinetic study of mavacamten in healthy volunteers in China. No new safety signals were observed following single oral doses of mavacamten in healthy adult subjects in China. The study demonstrated favorable pharmacokinetic properties, safety, and tolerability, consistent with the results of the Phase I pharmacokinetic study of mavacamten conducted by MyoKardia, Inc., a wholly-owned subsidiary of Bristol-Myers Squibb, in healthy volunteers in the United States.
This pharmacokinetic study is an open-label, parallel-group, single-center Phase I clinical trial designed to evaluate the single oral dose of mavacamten in 44 healthy Chinese volunteers. Running concurrently is the ongoing Phase III clinical trial of mavacamten for the treatment of Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). If the pharmacokinetic study and Phase III clinical trial yield positive results, it will support LianBio's submission of a "New Drug Application" to the National Medical Products Administration, aiding in the regulatory approval process for the drug in China.
"We would like to express our gratitude to all the volunteer participants and researchers involved in the Phase I pharmacokinetic study of mavacamten conducted in healthy volunteers in China," said Dr. Yizhe Wang, CEO of LianBio. "The rapid progress of this trial will help us achieve our goal of bringing the benefits of mavacamten to patients as soon as possible. As the ongoing EXPLORER-CN Phase III trial continues to advance, we believe that the results from this Phase I pharmacokinetic study will further accelerate our efforts to introduce this potentially groundbreaking drug to oHCM patients in China."
LianBio obtained the license authorization from MyoKardia, a wholly-owned subsidiary of Bristol-Myers Squibb, in August 2020, for the development and commercialization of mavacamten in mainland China, Hong Kong, Macao, Taiwan, Thailand, and Singapore. LianBio is currently conducting a multi-center, double-blind, randomized, placebo-controlled Phase III clinical trial—EXPLORER-CN—to evaluate the efficacy and safety of mavacamten in treating symptomatic oHCM patients in China. In February 2022, mavacamten was granted "Breakthrough Therapy" designation in China for the treatment of oHCM patients. In April 2022, the U.S. Food and Drug Administration (FDA) approved mavacamten (commercial name: Camzyos) for the treatment of symptomatic oHCM patients classified as New York Heart Association (NYHA) functional class II-III, to improve patient function and symptoms.
About Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy (HCM) is a chronic progressive disease caused by excessive myocardial contraction and obstruction of left ventricular blood filling, which can lead to debilitating symptoms and cardiac dysfunction. It is estimated that 1 in every 500 people worldwide has hypertrophic cardiomyopathy.
The most common cause of hypertrophic cardiomyopathy is genetic mutations in the proteins of the cardiac muscle sarcomere. In patients with either obstructive or non-obstructive hypertrophic cardiomyopathy, physical exertion can lead to fatigue or shortness of breath, impacting daily life. Hypertrophic cardiomyopathy is also associated with an increased risk of atrial fibrillation, stroke, heart failure, and sudden cardiac death.
About Camzyos (mavacamten)
CamzyosTM (mavacamten) is the first and currently the only myocardial myosin inhibitor approved by the U.S. FDA, indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult patients with New York Heart Association (NYHA) Class II-III heart function to improve patient function and symptoms. Camzyos is a selective allosteric reversible inhibitor of myocardial myosin. Camzyos modulates the number of myosin heads that can enter the "actin-binding" (force-generating) state, thereby reducing the probability of force-generating (systolic) and residual (diastolic) cross-bridge formation. Excessive formation of myosin-actin cross-bridges and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM. Camzyos shifts the overall myosin population to an energy-conserving, recruitable super-relaxed state. In HCM patients, inhibition of myosin by Camzyos reduces dynamic left ventricular outflow tract (LVOT) obstruction and improves cardiac filling pressures.
About LianBio
LianBio is a multinational biotechnology company with the mission of bringing disruptive drugs to patients in China and Asia, changing the long-standing lack of innovative drugs in the region. By collaborating with highly innovative global biopharmaceutical companies, LianBio is advancing its diversified pipeline of clinical drug candidates, which has the potential to establish new therapeutic standards for various indications in cardiovascular, oncology, ophthalmology, inflammatory diseases, and respiratory conditions. LianBio is building international infrastructure to position itself as a preferred partner and provide collaborators with access to the Chinese and other Asian markets.
Typesetting | Guo Yaqing
