KarXT demonstrated a statistically significant
9.2-point reduction in PANSS Total score from baseline at Week 5
compared to placebo (p=0.0014)
Trial also met all secondary endpoints,
demonstrating statistically significant reductions in positive and
negative symptoms of schizophrenia, as measured by the PANSS
positive subscale, PANSS negative subscale and PANSS negative
Marder factor score
KarXT has a tolerable safety profile with no
new or unexpected safety signals
Based on these results, Zai is moving swiftly
to submit New Drug Application (NDA) to China’s National Medical
Products Administration (NMPA) in early 2025
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced
positive topline results from the company’s Phase 3 multi-center
trial evaluating the safety and efficacy of KarXT (xanomeline and
trospium chloride) in China. Consistent with previous global
studies, the registrational bridging trial met its primary
endpoint, with KarXT demonstrating a statistically significant
9.2-point reduction in the Positive and Negative Syndrome Scale
(PANSS) total score compared to placebo at Week 5 (-16.9 KarXT vs.
-7.7 placebo, p=0.0014).
The study also met all key secondary efficacy endpoints,
demonstrating a significant improvement in PANSS positive symptom
subscale score, PANSS negative symptom subscale score, PANSS
negative Marder factor score, the Clinical Global
Impression-Severity (CGI-S) scale at week five and percentage of
PANSS responders at week five compared to placebo. Key secondary
endpoints were formally tested sequentially in a predefined
order.
Results at Week 5 include:
- 1.9-point reduction in the PANSS positive subscale with KarXT
compared to placebo (-6.5 KarXT vs. -4.6 placebo, p=0.0474).
- 2.5-point reduction in the PANSS negative subscale with KarXT
compared to placebo (-3.2 KarXT vs. -0.7 placebo, p=0.0062).
There were no safety signals that were new or unexpected in
comparison with prior KarXT trials in schizophrenia. Treatment
emergent adverse events in the treatment arm that occurred at ≥ 10%
and at least twice the rate in placebo include vomiting,
tachycardia, nausea, systemic hypertension, dizziness and diarrhea.
Based on these results, Zai Lab is moving swiftly to submit a new
drug application (NDA) to China’s National Medical Products
Administration (NMPA) for KarXT in schizophrenia in early 2025.
“The positive findings we observed in this bridging trial will
contribute to a large global dataset for KarXT and demonstrate that
this novel compound has the potential to be an important new
treatment option for adults with schizophrenia in China,” said
Rafael G. Amado, M.D., President, Head of Global Research and
Development, Zai Lab. “More than 8 million people in China live
with schizophrenia, and fewer than half receive treatment, while
many more do not get adequate symptom relief and suffer
debilitating side effects from available antipsychotic therapies.
This clinical trial is an example of Zai Lab’s capabilities as a
partner that helps to expand access to innovative treatments in
collaboration with our global partners.”
The Zai Lab Phase 3 multi-center, randomized, placebo-controlled
trial (ZL-2701-001) evaluated the efficacy and safety of KarXT in
202 acutely psychotic hospitalized adult patients with
schizophrenia in China. The study comprised two parts: a five-week
double-blind part followed by a 12-week open-label extension part.
Results shared today are from the five-week, double-blind trial
segment.
“We see on a daily basis the need for more effective and
tolerable treatment options for patients living with schizophrenia
in Greater China,” said Gang Wang, M.D., Director of National
Clinical Research Center for Mental Disorders, Dean of Beijing
Anding Hospital, Capital Medical University and the leading
principal investigator in the Zai Lab Phase 3 trial. “We are
encouraged that the data from this study further support KarXT as
an impactful treatment option for these patients.”
Full data from the trial will be presented at a future medical
conference.
About KarXT
KarXT (xanomeline and trospium chloride) is a combination of an
oral M1/M4-preferring muscarinic acetylcholine receptor agonist and
a muscarinic acetylcholine receptor antagonist. This combination is
in development for the treatment of psychiatric conditions,
including schizophrenia and Alzheimer’s-related psychosis.
Xanomeline preferentially stimulates muscarinic receptors in the
central nervous system implicated in these conditions, as compared
to current antipsychotic medicines, which mostly target dopamine or
serotonin receptors.
Zai Lab has an exclusive license from Karuna Therapeutics, Inc.,
a company later acquired by Bristol Myers Squibb, to develop,
manufacture, and commercialize KarXT in Greater China (mainland
China, Hong Kong, Macau, and Taiwan, collectively).
About Schizophrenia
Schizophrenia is a persistent and often disabling mental illness
affecting how a person thinks, feels, and behaves. It is
characterized by positive symptoms (hallucinations and delusions),
negative symptoms (difficulty enjoying life and withdrawal from
others), and cognitive impairment (deficits in memory,
concentration, and decision-making) – all of which can severely
impact functioning, with only 10% of people gainfully employed and
many struggling to meet adult milestones, such as living
independently. The life expectancy of people living with
schizophrenia is reduced by 10-20 years compared to the general
population. Schizophrenia affects nearly 24 million people
worldwide and is most commonly treated with antipsychotics.
Unfortunately, many people with schizophrenia continue to
experience limited efficacy or problematic side effects while on
antipsychotic therapy, and approximately 75% of patients
discontinue medication before 18 months. When schizophrenia
treatment is discontinued, it can lead to impacts on health
including relapse, hospitalization, and longer time to
remission.
More than 8 million people in China are living with
schizophrenia, yet fewer than half are receiving treatment, and
even fewer are obtaining adequate symptom improvement using the
current treatment of antipsychotics. Like patients globally, there
is a significant need for more effective therapies with improved
safety to treat serious psychiatric conditions for patients with
schizophrenia in Greater China.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative,
research-based, commercial-stage biopharmaceutical company based in
China and the United States. We are focused on discovering,
developing, and commercializing innovative products that address
medical conditions with significant unmet needs in the areas of
oncology, immunology, neuroscience, and infectious disease. Our
goal is to leverage our competencies and resources to positively
impact human health in China and worldwide.
For additional information about Zai Lab, please visit
www.zailaboratory.com or follow us at
www.twitter.com/ZaiLab_Global.
Forward-Looking Statements
This press release contains forward-looking statements relating
to our future expectations, plans, and prospects, including,
without limitation, statements relating to our collaboration with
Bristol Myers Squibb, the potential benefits, safety, and efficacy
of KarXT including the results from the pivotal Phase 3 EMERGENT-3
trial of KarXT in schizophrenia, and the potential treatment of
psychiatric and neurological conditions including schizophrenia and
dementia-related psychosis. These forward-looking statements may
contain words such as “aim,” “anticipate,” “believe,” “could,”
“estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,”
“possible,” “potential,” “will,” “would,” and other similar
expressions. Such statements constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements are not statements of
historical fact or guarantees or assurances of future performance.
Forward-looking statements are based on our expectations and
assumptions as of the date of this press release and are subject to
inherent uncertainties, risks, and changes in circumstances that
may differ materially from those contemplated by the
forward-looking statements. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors, including but not limited to (1) our
ability to successfully commercialize and generate revenue from our
approved products, (2) our ability to obtain funding for our
operations and business decisions, (3) the results of our clinical
and pre-clinical development of our product candidates, (4) the
content and timing of decisions made by the relevant regulatory
authorities regarding regulatory approvals of our product
candidates, (5) risks related to doing business in China, and (6)
other factors identified in our most recent annual and quarterly
reports and in other reports we have filed with the U.S. Securities
and Exchange Commission. We anticipate that subsequent events and
developments will cause our expectations and assumptions to change,
and we undertake no obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise, except as may be required by law.
These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
Our SEC filings can be found on our website at
www.zailaboratory.com and on the SEC’s website at www.sec.gov.
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version on businesswire.com: https://www.businesswire.com/news/home/20241029426072/en/
Investor Relations: Christine Chiou / Lina Zhang +1 (917)
886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com /
lina.zhang@zailaboratory.com
Media: Shaun Maccoun/ Xiaoyu Chen +1 (857) 270-8854 / +86
185 0015 5011 shaun.maccoun@zailaboratory.com /
xiaoyu.chen@zailaboratory.com
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