Analyses of pooled efficacy data from the EMERGENT program demonstrate significant improvements in schizophrenia symptoms

Analyses extend prior findings that KarXT is generally well tolerated with a low risk of common adverse events associated with current antipsychotics, including somnolence, weight gain, and movement disorders

Company submitted New Drug Application (NDA) for KarXT for the treatment of schizophrenia to the U.S. Food & Drug Administration (FDA) in September 2023

KarXT, a dual M1/M4 muscarinic agonist, would represent the first new mechanism of action to treat schizophrenia in several decades, if approved

Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced it will be presenting new efficacy, safety, and tolerability analyses from its EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia at the upcoming Neuroscience Education Institute (NEI) Congress, to be held November 9-12, 2023, in Colorado Springs, CO.

“In many patients, existing antipsychotics provide unreliable relief from schizophrenia’s disabling symptoms and carry undesirable side effects, amplifying the challenges of treatment adherence and leaving such patients open to relapse. These new findings bolster KarXT’s earlier data, demonstrating clinically meaningful symptom reduction along with strong tolerability,” said Stephen Brannan, M.D., chief medical officer of Karuna Therapeutics. “Karuna will continue to gather data through our EMERGENT clinical trial program to understand how KarXT’s novel mechanism of action could meaningfully bridge current treatment gaps for patients and their care partners.”

Details of the presentations are as follows:

• Poster Title: Efficacy of KarXT (Xanomeline–Trospium) in Schizophrenia: Pooled Results From the Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials
  • Poster Number: 32
  • Date & Time: Friday, November 10, 3:15 – 4:45 p.m. MT (5:15 – 6:45 p.m. ET)
  • Presenter: Judy Kando, PharmD, BCPP, Executive Director, Field Medical Lead, Medical Affairs, Karuna Therapeutics

• Poster Title: Safety and Tolerability of KarXT (Xanomeline–Trospium): Pooled Results From the Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials
  • Poster Number: 99
  • Date & Time: Friday, November 10, 3:15 – 4:45 p.m. MT (5:15 – 6:45 p.m. ET)
  • Presenter: Judy Kando, PharmD, BCPP, Executive Director, Field Medical Lead, Medical Affairs, Karuna Therapeutics

• Poster Title: Pooled Analysis of EPS-Like Symptoms in the EMERGENT Program of KarXT in Schizophrenia
  • Poster Number: 85
  • Date & Time: Friday, November 10, 3:15 – 4:45 p.m. MT (5:15 – 6:45 p.m. ET)
  • Presenter: Peter Weiden, M.D., clinical professor of psychiatry, Renaissance School of Medicine, Stony Brook University

The company will also sponsor a symposium during the congress on Friday, November 10^th, from 6:45 – 7:45 p.m. MT (8:45 – 9:45 p.m. ET), titled, “Forging a New Path: Targeting Muscarinic Receptor Circuits in Schizophrenia.” The event will describe the complex neurocircuitry of schizophrenia and the evolving class of investigational therapeutics, which target acetylcholine muscarinic receptors, and their potential to address unmet needs within the treatment landscape.

In September 2023, the company filed an NDA for KarXT for the treatment of schizophrenia in adults to the U.S. FDA. The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia. The EMERGENT program includes the three completed positive EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating the efficacy and safety of KarXT compared to placebo, and the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety of KarXT.

About KarXT

KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis related to Alzheimer’s disease. Through its novel mechanism of action, KarXT acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which is thought to improve positive, negative, and cognitive symptoms of schizophrenia. Unlike existing treatments, KarXT does not directly block dopamine receptors, representing a potential new approach to treating schizophrenia.

About Schizophrenia

Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels, and behaves, and affects nearly 24 million people worldwide, including 2.8 million people in the U.S. It is characterized by three symptom domains: positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making). In part due to limitations with current treatments, people living with schizophrenia often struggle to maintain employment, live independently, and manage relationships. While current treatments can be effective in managing select symptoms, approximately 30% of people do not respond to therapy, with an additional 50% experiencing only a partial improvement in symptoms or unacceptable side effects.

About Karuna

Karuna Therapeutics is a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by serious mental illness. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com.

Forward-Looking Statements

This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our goals to develop and commercialize our product candidates, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to obtain necessary funding, our ability to generate positive clinical trial results for our product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, risks relating to business interruptions, and other risks set forth under the heading “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2022 and in our subsequent filings with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

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