LianBio (Nasdaq: LIAN), a biotechnology company dedicated to
bringing innovative medicines to patients in China and other Asian
markets, today announced that CAMZYOS® (mavacamten) has
received marketing approval for the treatment of adults with
symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the
Singapore Health Sciences Authority.
“Clinical trials have demonstrated that CAMZYOS has the
potential to improve symptoms, quality of life, and functional
status in symptomatic oHCM,” said Lin Weiqin, Clinical Director,
Heart Failure and Cardiomyopathy Programme, National University
Heart Centre, Singapore (NUHCS), and Assistant Professor, Yong Loo
Lin School of Medicine, National University of Singapore (NUS).
“The approval of CAMZYOS in Singapore brings a much needed,
effective new treatment option to our local oHCM patients.”
Marketing approval in Singapore was based on data from the Phase
3 EXPLORER-HCM trial. Results from the Phase 3 EXPLORER-HCM trial,
which evaluated CAMZYOS in patients with symptomatic obstructive
HCM versus placebo, met all primary and secondary endpoints with
statistical significance. In EXPLORER-HCM, CAMZYOS demonstrated a
clear treatment effect, with clinically meaningful improvements in
exercise capacity and symptoms, and functional status, as well as
clinically meaningful improvement in left ventricular outflow tract
obstruction.
"LianBio is committed to bringing mavacamten to symptomatic oHCM
patients in Asia,” said Yizhe Wang, Ph.D., Chief Executive Officer
of LianBio. “Mavacamten is now approved in both Singapore and
Macau, with additional New Drug Applications on file in Mainland
China and Hong Kong. We look forward to continuing to work with
regulators in the region to accelerate access to this promising new
therapeutic option for patients in need.”
About Mavacamten
CAMZYOS (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 oHCM to improve functional capacity and symptoms. It has
also received regulatory approvals in Australia, Canada, Brazil,
Switzerland, Macau, 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 left ventricular
outflow tract (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-HCMThe EXPLORER-HCM Phase 3
trial (NCT03470545) was a double-blind, randomized,
placebo-controlled, parallel group trial that enrolled a total of
251 adult patients with symptomatic (NYHA class II or III),
obstructive hypertrophic cardiomyopathy. All participants had
measurable left ventricular ejection fraction (LVEF) ≥55% and at
least one peak LVOT gradient ≥50 mmHg (at rest or with provocation
at diagnosis); in addition, Valsalva LVOT gradient ≥30 mmHg at
baseline was required at screening. Ninety-two percent of patients
were on background therapies of a beta blocker or calcium channel
blocker. The primary endpoint was a composite functional endpoint,
assessed at 30 weeks, and was defined as the proportion of patients
who achieved either improvement of mixed venous oxygen tension
(pVO2) by ≥1.5 mL/kg/min plus improvement in NYHA class by at least
1 or improvement of pVO2 by ≥3.0 mL/kg/min plus no worsening in
NYHA class. Key secondary endpoints include impact on exercise
gradient LVOT, pVO2, NYHA Class and Kansas City Cardiomyopathy
Questionnaire (KCCQ) and Hypertrophic Cardiomyopathy Symptom
Questionnaire (HCMSQ) at Week 30.
About Hypertrophic CardiomyopathyHCM 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 both obstructive and
non-obstructive HCM patients, 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.
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.
Cautionary Note Regarding Forward-Looking
StatementsStatements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
forward-looking statements. The words “expect,” “believe,”
“continue,” “estimate,” “potential,” “will” and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Forward-looking statements in this press release include, but are
not limited to, statements regarding the therapeutic potential of
CAMZYOS and LianBio’s ability to accelerate patient access to
mavacamten in Asia. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including: LianBio’s ability to successfully
initiate and conduct its planned clinical trials and complete such
clinical trials and obtain results on its expected timelines, or at
all; LianBio’s plans to leverage data generated in its partners’
global registrational trials and clinical development programs to
obtain regulatory approval and maximize patient reach for its
product candidates; LianBio’s ability to identify new product
candidates and successfully acquire such product candidates from
third parties; competition from other biotechnology and
pharmaceutical companies; general market conditions; the impact of
changing laws and regulations and those risks and uncertainties
described in LianBio’s filings with the U.S. Securities and
Exchange Commission (SEC), including LianBio’s Annual Report on
Form 10-K for the year ended December 31, 2022 and subsequent
filings with the SEC.
Any forward-looking statements contained in this press release
speak only as of the date hereof, and LianBio specifically
disclaims any obligation to update any forward-looking statement,
whether as a result of new information, future events or otherwise.
Readers should not rely upon this information as current or
accurate after its publication date.
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 Canale
E: katherine.smith@evokegroup.com
T: +1 619 849 5378
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