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Press Release

Karuna Pharmaceuticals to Present Results of KarXT Phase 1 Study at American College of Neuropsychopharmacology Annual Meeting

Karuna Pharmaceuticals,Inc.
Posted on: 10 Dec 18

Karuna Pharmaceuticals, Inc. (“Karuna”), focused on targeting muscarinic cholinergic receptors for the treatment of neuropsychiatric disorders marked by psychosis and cognitive impairment, today announced that Stephen Brannan, MD, Chief Medical Officer of Karuna, will present a poster outlining results of the Phase 1 study of its proprietary KarXT (Karuna-Xanomeline-Trospium) co-formulation, on Monday, December 10, 2018, from 5:30-7:30pm EST at the American College of Neuropsychopharmacology (ACNP) annual meeting in Hollywood, Florida.

The Phase 1 dose-ranging study of KarXT enrolled 69 healthy volunteers and successfully demonstrated tolerability at dose levels exceeding those shown to be efficacious in previous studies of xanomeline alone. The co-formulation also achieved exposure levels equivalent to or higher than the separate dosage forms used previously, and the results supported dose selection to be carried forward into Phase 2. There were no severe or serious adverse events reported in the co-formulation study. Side effects associated with KarXT were mild-to-moderate and transient in nature, often only lasting a few hours, and they were consistent with the previous KarXT study that used separate dosage forms for xanomeline and trospium.

The new KarXT co-formulation performed well in humans and has been carried forward into a Phase 2 study in a double-blind, placebo-controlled study designed to evaluate the efficacy and safety of KarXT in approximately 160 patients with schizophrenia. Top-line results from the Phase 2 study are expected at the end of 2019.

About KarXT
KarXT (Karuna-Xanomeline-Trospium) is Karuna’s lead investigational product candidate for the treatment of psychosis in schizophrenia. It consists of xanomeline, a novel muscarinic acetylcholine receptor agonist that has demonstrated efficacy in placebo-controlled human trials in schizophrenia and Alzheimer’s disease, and trospium chloride, an FDA-approved and well-established muscarinic receptor antagonist that has been shown not to enter the central nervous system (CNS). KarXT is designed to selectively target M1/M4 muscarinic receptors in the brain while blocking their activation in peripheral tissues to significantly improve tolerability. Results from a Phase 1 study demonstrating the improved tolerability of KarXT vs. xanomeline alone were announced in 2016, and a more recent Phase 1 study completed in 2018 supported the development of a co-formulation of KarXT that is now being evaluated in a Phase 2 study.

About Karuna Pharmaceuticals
Karuna is a clinical-stage drug development company targeting muscarinic cholinergic receptors for the treatment of psychosis and cognitive impairment across central nervous system (CNS) disorders, including schizophrenia and Alzheimer’s disease, as well as pain. Karuna’s lead product candidate, KarXT (Karuna-Xanomeline-Trospium), is being evaluated in a Phase 2 study in people with schizophrenia, with top-line results anticipated at the end of 2019. Karuna, which was founded by PureTech Health (LSE: PRTC), has a worldwide exclusive license for xanomeline and has a patent portfolio more broadly covering selective muscarinic targeting enabled by the KarXT approach. For more information, visit www.karunapharma.com.

Forward Looking Statement
This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20181210005812/en/

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Last updated on: 10/12/2018

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