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 presented in a
late-breaking science session at the European Society of Cardiology
(ESC) Congress 2023 and simultaneously published in a JAMA
Cardiology paper titled, “Effect of Mavacamten on Chinese Patients
With Symptomatic Obstructive Hypertrophic Cardiomyopathy.”
LianBio previously announced topline data from EXPLORER-CN, with
mavacamten demonstrating statistically significant and clinically
meaningful improvement in Valsalva left ventricular outflow tract
(LVOT) peak gradient, the study’s primary endpoint. Mavacamten also
demonstrated improvement across all secondary endpoints, including
LVOT obstruction, clinical symptoms, and health status.
The data presented at ESC 2023 and published in JAMA Cardiology
continue to demonstrate robust evidence of mavacamten’s therapeutic
benefit. New data published today provide additional detail showing
mavacamten’s impact on reducing cardiac biomarkers associated with
poor prognosis in oHCM, and improvement in biomarkers associated
with cardiac structure remodeling. In addition, the study
demonstrated mavacamten’s efficacy across prespecified subgroups,
including beta-blocker usage, sex, age, body mass index, New York
Heart Association (NYHA) class, and CYP2C19 metabolizer
phenotype.
“EXPLORER-CN demonstrates mavacamten’s broad treatment effect in
oHCM,” said Zhuang Tian, M.D., Professor of Cardiology, and Deputy
Director of the International Medical Department, Peking Union
Medical College Hospital, and EXPLORER-CN Investigator. “With
improvement seen across LVOT obstruction, clinical symptoms, health
status, cardiac biomarkers, and cardiac structure, mavacamten has
the potential to be a meaningful new treatment options for patients
in China.”
The randomized, controlled, Phase 3 EXPLORER-CN trial enrolled
81 patients with symptomatic oHCM. All patients had significant
LVOT obstruction at baseline. The mean left ventricular ejection
fraction (LVEF) was similar between the mavacamten and placebo
groups. Most patients were receiving background beta-blockers in
both groups.
As previously reported, EXPLORER-CN met its primary endpoint,
demonstrating a statistically significant and clinically meaningful
improvement in Valsalva LVOT peak gradient compared to placebo
after 30 weeks of treatment (least-squares mean difference, −70.29
mm Hg; 95% CI, −89.64 to −50.94; 1-sided p< .001). The reduction
in Valsalva LVOT peak gradient with mavacamten treatment started as
early as 4 weeks and was sustained through week 30. Data published
today showed consistent benefit for the primary endpoint was
observed across prespecified subgroups, regardless of beta-blocker
use or CYP2C19 phenotype.
Among the new data published today, cardiac biomarkers decreased
with mavacamten treatment from week 4 and were sustained throughout
the study period. At week 30, reduction in N-terminal pro-B-type
natriuretic peptide (NT-proBNP) was 82% greater for mavacamten
compared with placebo (proportion of geometric mean ratio [GMR],
0.18; 95% CI, 0.13 to 0.24). Reduction in high-sensitivity cardiac
troponin I (hs-cTnI) was 66% greater in the mavacamten group
compared with placebo (proportion of GMR, 0.34; 95% CI, 0.27 to
0.42). NT-proBNP and cardiac troponin are biomarkers of cardiac
wall stress and myocardial injury that have been associated with
poor clinical outcomes, including heart failure, atrial
fibrillation, and death in HCM patients.
Improvements in cardiac structure were also observed in patients
treated with mavacamten. Among 58 eligible patients with cardiac
magnetic resonance (CMR) data available, secondary and exploratory
CMR endpoints revealed favorable markers for cardiac remodeling
with mavacamten from baseline to week 30, including reductions in
left ventricular mass index (LVMI) (mean difference, −30.80 g/m2;
95% CI, −41.55 to −20.05), left ventricular mass (mean difference,
−52.64 g; 95% CI, −67.89 to −37.39), maximum left atrial volume
index (mean difference, −18.27 mL/m2; 95% CI, −26.72 to −9.83), and
left ventricular maximal wall thickness (mean difference, −3.52 mm;
95% CI, −4.65 to −2.38), all of which are predictors of poor
outcomes in oHCM.
As previously reported, safety results in the trial were
consistent with previous studies of mavacamten in symptomatic oHCM,
and no new safety signals were reported. Resting LVEF remained
stable in both groups throughout treatment, and no participants in
the study experienced decreases in LVEF <50 % that required dose
interruption.
In April 2023, the China National Medical Products
Administration (NMPA) accepted with Priority Review a New Drug
Application (NDA) for mavacamten for the treatment of adults with
symptomatic oHCM.
“Mavacamten is the first pharmacological tool developed to
specifically target the underlying pathophysiology of oHCM in
China,” said Michael Humphries, FRCP, Chief Scientific Advisor and
Head of General Medicine Development, LianBio. “The EXPLORER-CN
trial demonstrates that the well-established therapeutic benefit of
this drug also extends to Chinese patients. We thank the
EXPLORER-CN patients and investigators for their dedication to this
study and look forward to making mavacamten available to oHCM
patients in China in the coming year.”
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, and in the European Union,
indicated for the treatment of symptomatic (NYHA, class II-III)
obstructive HCM in adult patients. It has also received regulatory
approvals in Australia, Brazil, Canada, Great Britain, Macau,
Singapore, South Korea and Switzerland. 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 Chinese patients 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 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.
More information about the EXPLORER-CN trial can be found on
ClinicalTrials.gov (NCT05174416) or
http://www.chinadrugtrials.org.cn/index.html (CTR20212890).
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.
Cautionary Note Regarding Forward-Looking
Statements
Statements 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 “may”, “continue,”
“estimate,” 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 LianBio’s plans to make mavacamten available
to oHCM patients in China in the coming year. 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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