Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia
“There are more than 8 million patients living with schizophrenia in
“KarXT is the first new class of treatment for patients with schizophrenia in several decades,” said
The NDA submission is supported by the results from a Phase 1 China Pharmacokinetics (PK) study, the Phase 3 China study (ZL-2701-001) and data from the global EMERGENT clinical programs.
The China Phase 3 study met its primary endpoint, with KarXT demonstrating a statistically significant 9.2-point difference from placebo in the reduction in the Positive and Negative Syndrome Scale (PANSS) total score from baseline 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. There were no safety signals that were new or unexpected in comparison with prior KarXT trials in schizophrenia. Similar to the global program, the common treatment emergent adverse events in the treatment arm include vomiting, tachycardia, nausea, systemic hypertension, dizziness and diarrhea.
In the global Phase 3 EMERGENT-2 and EMERGENT-3 trials, KarXT met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms compared to placebo. The safety and tolerability profile of KarXT has been established across acute and long-term trials.
In
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 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.
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 (e.g., hallucinations and delusions), negative symptoms (e.g., difficulty enjoying life and withdrawal from others), and cognitive impairment (e.g., deficits in memory, concentration, and decision-making) – all of which can severely impact functioning, with only 10% of patients 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 current 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
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Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements regarding the prospects of and plans for developing and commercializing KarXT, the potential benefits of KarXT, and the potential treatment of schizophrenia and other psychiatric and neurological conditions including Alzheimer’s-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
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