LianBio Announces Phase 3 EXPLORER-CN Data Accepted for Late-Breaking Presentation at the European Society of Cardiology Congress 2023
17 Julio 2023 - 5:00AM
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to
bringing innovative medicines to patients in China and other major
Asian markets, today announced data from the Phase 3
EXPLORER-CN trial of mavacamten in Chinese symptomatic obstructive
hypertrophic cardiomyopathy (oHCM) patients were accepted for a
late-breaking presentation at the European Society of Cardiology
(ESC) Congress 2023 taking place August 25-28, 2023 in Amsterdam,
Netherlands.
Presentation details are as follows:
Title: EXPLORER-CN – Efficacy and safety of
mavacamten in Chinese adults with symptomatic obstructive
hypertrophic cardiomyopathy Session: Late-breaking
science on valve disease and hypertrophic cardiomyopathy
Presenter: Zhuang Tian, M.D., Professor of
Cardiology and Deputy Director of the Internal Medical Department,
Peking Union Medical College Hospital Date: August
28, 2023Session Time: 16:30 – 17:30 CEST
Presentation Time: 17:00
CESTLocation: Hub Mondrian – The Hub
About MavacamtenCamzyos® (mavacamten) is the
first and only cardiac myosin inhibitor approved by the U.S. FDA
indicated for the treatment of adults with symptomatic New York
Heart Association (NYHA) class II-III obstructive HCM to improve
functional capacity and symptoms. It has also received regulatory
approvals in Australia, Canada, Brazil, Switzerland, Macau, the
European Union, South Korea and Singapore. Camzyos is an allosteric
and reversible inhibitor selective for cardiac myosin. Camzyos
modulates the number of myosin heads that can enter “on actin”
(power generating) states, thus reducing the probability of force
producing (systolic) and residual (diastolic) cross-bridge
formation. Excess myosin actin cross bridge formation and
dysregulation of the super relaxed state are mechanistic hallmarks
of HCM. Camzyos shifts the overall myosin population towards an
energy sparing, recruitable, super relaxed state. In HCM patients,
myosin inhibition with Camzyos reduces dynamic LVOT obstruction and
improves cardiac filling pressures.
LianBio licensed rights from MyoKardia, now a wholly owned
subsidiary of Bristol Myers Squibb, in August 2020 for the
development and commercialization of mavacamten in Mainland China,
Hong Kong, Macau, Taiwan, Thailand and Singapore. Mavacamten was
granted Breakthrough Therapy Designation in China for the treatment
of patients with oHCM in February 2022.
About EXPLORER-CNThe Phase 3 EXPLORER-CN trial
enrolled a total of 81 patients in China with symptomatic (NYHA
Class II or III) oHCM. All participants had one measurable LVOT
gradient (resting or Valsalva) ≥50 mmHg during screening. Patients
were randomized 2:1 to mavacamten or placebo.
The primary endpoint for EXPLORER-CN is the change from baseline
to week 30 in Valsalva LVOT peak gradient. Secondary endpoints
include change from baseline to week 30 in resting LVOT peak
gradient, proportion of participants achieving a Valsalva LVOT peak
gradient <30 mmHg at week 30, proportion of participants
achieving a Valsalva LVOT peak gradient <50 mmHg at week 30,
proportion of participants with at least one NYHA class improvement
from baseline to week 30, change from baseline to week 30 in Kansas
City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
(CSS), change from baseline to week 30 in N-terminal pro-B-type
natriuretic peptide (NT-proBNP), change from baseline to week 30 in
cardiac troponin, and change from baseline to week 30 in left
ventricular mass index evaluated by cardiac magnetic resonance
imaging.
About Hypertrophic CardiomyopathyHypertrophic
cardiomyopathy (HCM) is a chronic, progressive disease in which
excessive contraction of the heart muscle and reduced ability of
the left ventricle to fill can lead to the development of
debilitating symptoms and cardiac dysfunction. HCM is estimated to
affect one in every 500 people globally. The most frequent cause of
HCM is mutations in the heart muscle proteins of the sarcomere. In
patients with both obstructive and non-obstructive HCM, exertion
can result in fatigue or shortness of breath, interfering with a
patient’s ability to participate in activities of daily living. HCM
has also been associated with increased risks of atrial
fibrillation, stroke, heart failure and sudden cardiac death.
In China, there are an estimated 1.1 million to 2.8 million
patients with HCM.
About LianBioLianBio is a cross-border
biotechnology company on a mission to bring transformative
medicines to historically underserved patients in China and other
Asian markets. Through partnerships with highly innovative
biopharmaceutical companies around the world, LianBio is advancing
a diversified portfolio of clinically validated product candidates
with the potential to drive new standards of care across
cardiovascular, oncology, ophthalmology, and inflammatory disease.
LianBio is establishing an international infrastructure to position
the company as a partner of choice with a platform to provide
access to China and other Asian markets. For more information,
please visit www.lianbio.com.
For investor inquiries, please contact:
Elizabeth Anderson, VP Communications and Investor
Relations E:
elizabeth.anderson@lianbio.com T: +1 646 655
8390
For media inquiries, please contact:
Josh Xu, Director of Communications
E: josh.xu@lianbio.com T: +86 136
6140 8315
Katherine Smith, Evoke
CanaleE: katherine.smith@evokegroup.com
T: +1 619 849 5378
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