- NBI-1117568 is an oral, selective muscarinic M4 receptor
agonist advancing through Phase 2 clinical development under a
multi-program collaboration with Neurocrine Biosciences
- Successful completion of a long-term preclinical toxicity
program to support safe, chronic dosing of NBI-1117568 in future
clinical trials triggers a $15 million payment to Nxera from
Neurocrine Biosciences
Tokyo, Japan and Cambridge, UK, 16 April
2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company;
TSE 4565) – formerly known as Sosei Group or Sosei Heptares – has
been notified by its partner Neurocrine Biosciences Inc.
(“Neurocrine”; Nasdaq: NBIX) that NBI-1117568, an oral selective
muscarinic M4 receptor agonist being advanced in Phase 2 clinical
trials by Neurocrine for the treatment of schizophrenia and other
neuropsychiatric disorders, has successfully completed a long-term
preclinical toxicity program that meets US FDA requirements to
allow for safe, chronic (i.e. long-term) dosing in future clinical
trials. The achievement of this important safety development
milestone triggers a $15 million payment to Nxera from
Neurocrine.
NBI-1117568 is the most advanced candidate from
a broad portfolio of novel clinical and preclinical
subtype-selective muscarinic M4, M1 and dual M1/M4 receptor
agonists discovered by Nxera and advancing under the 2021 global
collaboration with Neurocrine for the treatment of major
neurological disorders. These candidates have potential to address
a range of neurological and neuropsychiatric conditions and
include:
- NBI-1117568 (an M4 selective agonist) in Phase 2 trials with
top-line data expected in H2 2024
- NBI-1117570 (an M1/M4 selective dual agonist) in Phase 1
- NBI-1117569 (an M4-preferring agonist) in Phase 1
- NBI-1117567* (an M1-preferring agonist) expected to enter Phase
1 in 2024
Matt Barnes, EVP, President of Nxera
Pharma UK and Head of R&D, commented: “We are
delighted that NBI-1117568 has successfully achieved this important
safety development milestone. These results will support the safe,
long-term use of this novel clinical candidate, which is consistent
with a desired product profile for schizophrenia and other
neurological diseases where patients often need therapy over many
years. We are extremely pleased at the progress being made under
our highly productive partnership with Neurocrine and look forward
to reporting further progress and upcoming clinical data readouts,
including the top-line Phase 2 data on NBI-1117568, which is
expected in the second half of 2024.”
*Nxera retains rights to develop M1 agonists
advancing under this collaboration in Japan in all indications.
–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 NBI-1117568NBI-1117568 is
an oral, selective muscarinic M4 receptor agonist discovered by
Nxera Pharma and being developed in Phase 2 clinical trials by
Neurocrine for the treatment of schizophrenia and other
neuropsychiatric disorders. As a selective M4 orthosteric agonist,
NBI-1117568 offers the potential to deliver therapeutic effects
without the need of combination therapy to minimize side effects,
as required with non-selective muscarinic agonists, whilst also
avoiding the requirement for cooperativity with acetylcholine (ACh)
when compared to positive allosteric modulators. Clinical studies
completed to date have shown NBI-1117568 to be generally well
tolerated.
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 “NxWaveTM” 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.lifeLinkedIn: @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.