- 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
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
*Nxera retains rights to develop M1 agonists advancing under this collaboration in
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About Muscarinic Receptors
Muscarinic 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-1117568
NBI-1117568 is an oral, selective muscarinic M4 receptor agonist discovered by
About the Agreement with Neurocrine Biosciences
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
Nxera is eligible to receive R&D funding plus development, regulatory and commercial milestones of up to
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
In addition to several products being commercialized in
Nxera employs over 350 talented people at key locations in
For more information, please visit www.nxera.life
LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma
Enquiries:
Nxera – Media and Investor Relations
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life
+44 (0)203 928 6900 | Nxera@medistrava.com
Forward-looking statements
This 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.
Source:
2024 GlobeNewswire, Inc., source