Tokyo, Japan and Cambridge, UK, 9 May
2024 – Nxera Pharma (“the Company” or “Nxera”; TSE: 4565) notes
that its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq:
NBIX), a leading neuroscience-focused biopharmaceutical company,
announced that it has initiated its Phase 1 first-in-human clinical
study to evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of investigational compound NBI-1117567 in healthy
adult participants – see Neurocrine press announcement here.
NBI-1117567 is an investigational, oral,
muscarinic M1 preferring (M1/M4) selective agonist discovered by
Nxera that may have the potential to treat symptoms of cognition in
patients with neurological and neuropsychiatric conditions.
The clinical development milestone achieved with
this compound as announced does not trigger a milestone payment
from Neurocrine to Nxera under the terms of the 2021 agreement
between the companies. Milestone payments, under the agreement, are
payable upon the achievement of multiple, defined development
events for each program. Nxera will announce the receipt of any
milestone payments in accordance with TSE reporting
requirements.
–END–
About Muscarinic ReceptorsMuscarinic
receptors are G protein-coupled receptors (GPCRs) found in multiple
tissues including the brain, cardiovascular system, and
gastrointestinal tract. Selective activation of M4 and M1 receptors
in the brain is a clinically validated approach to treating
cognitive and neuropsychological symptoms of neurological diseases,
including Schizophrenia, dementia associated with Alzheimer’s
disease, Parkinson’s disease, and others.
Until now, attempts to develop medicines that
selectively target M4 and M1 receptors have been unsuccessful
because of side effects caused by the activation of M2 and M3
receptors. Highly selective M4 or M1 agonists that do not activate
M2 or M3 therefore are highly sought after and expected to have the
potential to address major unmet medical needs with blockbuster
potential.
About the Agreement with Neurocrine
Biosciences Nxera Pharma and Neurocrine BioSciences
entered a collaboration and licensing agreement in November 2021 to
develop novel muscarinic receptor agonists for the treatment of
schizophrenia, dementia and other neuropsychiatric disorders.
Under the terms of the agreement, Neurocrine
gains development and commercialization rights to a broad portfolio
of novel clinical and preclinical subtype-selective muscarinic M4,
M1 and dual M1/M4 receptor agonists discovered by Nxera. Neurocrine
is responsible for development costs associated with the programs
globally, except for M1 agonists being developed in Japan. Nxera
retains rights to develop M1 agonists in Japan for any indication,
with Neurocrine receiving co-development and profit share
options.
Nxera is eligible to receive R&D funding
plus development, regulatory and commercial milestones of up to
US$2.6 billion, with further product royalties, provided the
criteria under the agreement are satisfied.
About Neurocrine Biosciences Neurocrine
Biosciences is a leading neuroscience-focused, biopharmaceutical
company with a simple purpose: to relieve suffering for people with
great needs, but few options. We are dedicated to discovering and
developing life-changing treatments for patients with
under-addressed neurological, neuroendocrine, and neuropsychiatric
disorders. The company’s diverse portfolio includes FDA-approved
treatments for tardive dyskinesia, chorea associated with
Huntington’s disease, endometriosis* and uterine fibroids*, as well
as a robust pipeline including multiple compounds in mid- to
late-phase clinical development across our core therapeutic areas.
For three decades, we have applied our unique insight into
neuroscience and the interconnections between brain and body
systems to treat complex conditions. We relentlessly pursue
medicines to ease the burden of debilitating diseases and
disorders, because you deserve brave science. For more information,
visit neurocrine.com, and follow the company on LinkedIn, X
(Formerly Twitter), and Facebook. (*in collaboration with
AbbVie)
NEUROCRINE BIOSCIENCES, NEUROCRINE, and YOU
DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine
Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine
Biosciences, Inc.
About Nxera PharmaNxera Pharma (formerly
Sosei Heptares) is a technology powered biopharma company, in
pursuit of new specialty medicines to improve the lives of patients
with unmet needs in Japan and globally.
In addition to several products being
commercialized in Japan, we are advancing an extensive pipeline of
over 30 active programs from discovery through to late clinical
stage internally and in partnership with leading pharma and biotech
companies. This pipeline is focused on addressing major unmet needs
in some of the fastest-growing areas of medicine across neurology,
GI and immunology, metabolic disorders and rare diseases, and
leverages the power of our unique and industry leading
GPCR-targeted structure-based drug discovery “NxWave™” platform to
provide a sustainable source of best- or first-in-class
candidates.
Nxera employs over 350 talented people at key
locations in Tokyo and Osaka (Japan), London and Cambridge (UK),
Basel (Switzerland) and Seoul (South Korea) and is listed on the
Tokyo Stock Exchange (ticker: 4565).
For more information, please visit
www.nxera.life LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube:
@NxeraPharma
Enquiries:
Nxera – Media and Investor
RelationsKentaro Tahara, VP Investor Relations and Corporate
StrategyShinichiro Nishishita, VP Investor Relations, Head of
Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3
5210 3399 | +44 (0)1223 949390 |IR@Nxera.life
MEDiSTRAVA Consulting (for International
Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203
928 6900 | Nxera@medistrava.com
Forward-looking statementsThis press
release contains forward-looking statements, including statements
about the discovery, development, and commercialization of
products. Various risks may cause Nxera Pharma Group’s actual
results to differ materially from those expressed or implied by the
forward looking statements, including: adverse results in clinical
development programs; failure to obtain patent protection for
inventions; commercial limitations imposed by patents owned or
controlled by third parties; dependence upon strategic alliance
partners to develop and commercialize products and services;
difficulties or delays in obtaining regulatory approvals to market
products and services resulting from development efforts; the
requirement for substantial funding to conduct research and
development and to expand commercialization activities; and product
initiatives by competitors. As a result of these factors,
prospective investors are cautioned not to rely on any
forward-looking statements. We disclaim any intention or obligation
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.