Karuna Therapeutics to Present Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the American Society of Clinical Psychopharmacology Annual Meeting

By: Karuna Therapeutics, Inc. via Business Wire

May 22, 2023 at 06:30 AM EDT

Karuna Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that data from the EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating KarXT in schizophrenia will be presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held from May 30, 2023 to June 2, 2023 in Miami, Florida. An oral pipeline presentation will include efficacy and safety data from the three EMERGENT trials and a late-breaking poster presentation will share exploratory analyses of the effect of KarXT on cognitive impairment in patients with schizophrenia from the three EMERGENT trials.

“We look forward to presenting additional data from the EMERGENT program to help increase understanding of the safety and efficacy profile of KarXT and further illustrate its potential as a novel mechanism for the treatment of schizophrenia, an area of significant unmet need,” said Stephen Brannan, M.D., chief medical officer of Karuna Therapeutics. “The data being presented at ASCP add to the growing body of evidence which suggests that KarXT may have an impact on the multiple symptom domains of schizophrenia and, if approved, could offer people living with schizophrenia a new and important treatment option.”

Details of the presentations are as follows:

Presentation Title: Safety and Efficacy of KarXT in Patients with Schizophrenia in the Randomized, Double-Blind, Placebo-Controlled, Phase 3 EMERGENT-2 and EMERGENT-3 Trials

Date & Time: Tuesday, May 30, 2:10 – 2:20 p.m. ET

Presenter: Stephen Brannan, M.D., chief medical officer of Karuna Therapeutics

Symposium Title: Pharmaceutical Pipeline Session

Poster Title: The Potential Role of the M1/M4 Muscarinic Receptor Agonist KarXT in the Treatment of Cognitive Impairment in Patients with Schizophrenia

Poster Number: W77

Date & Time: Wednesday, May 31, 11:15 a.m. – 1:00 p.m. ET

Presenter: Phillip Harvey, Ph.D., University of Miami Miller School of Medicine

Symposium Title: Poster Session I with Lunch

About KarXT

KarXT (xanomeline-trospium) is an oral, investigational M1/M4-preferring muscarinic agonist in development for the treatment of psychiatric and neurological conditions, including schizophrenia and psychosis in Alzheimer’s disease. KarXT is the first potential medicine of its kind with a novel dual mechanism of action. Unlike current therapies, KarXT does not rely on the dopaminergic or serotonergic pathways, and it is designed to harness the therapeutic potential of xanomeline while managing peripheral side effects through trospium. This approach has the potential to provide a differentiated therapy, and, if approved, to beneficially impact the lives of millions of people with serious mental illness.

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 10-25 years compared to the general population. Schizophrenia affects more than 21 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.

About Karuna

Karuna Therapeutics is a clinical-stage biopharmaceutical company driven to create 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 expectations about the timing of our ongoing and planned clinical trials and regulatory filings, our goals to develop and commercialize our product candidates, our liquidity and capital resources 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 resulting from the coronavirus (COVID-19) pandemic, 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.