Karuna Pharmaceuticals to Present Results of KarXT Phase 1 Study at American College of Neuropsychopharmacology Annual Meeting
December 10 2018 - 4:05PM
Business Wire
CMO Stephen Brannan to present Phase 1 results
of a multi-dose safety study aimed at optimizing combination of
Xanomeline and Trospium Chloride
Proprietary co-formulation being evaluated in
ongoing Phase 2 with results expected in 2019
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 KarXTKarXT (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 PharmaceuticalsKaruna 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 StatementThis 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20181210005812/en/
Karuna Pharmaceuticals, Inc.InvestorsAllison Mead Talbot,
+1 617-651-3156amt@puretechhealth.comorU.S. mediaTom
Donovan, +1 857-559-3397tom@tenbridgecommunications.com
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