Tokyo, Japan and Cambridge, UK, 14 January 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) is pleased to report on progress being made by Neurocrine Biosciences, Inc. (“Neurocrine”) regarding the clinical development of its partnered muscarinic agonist portfolio. These updates were presented by Neurocrine at the 43rd Annual J.P. Morgan Healthcare Conference. The update presented by Neurocrine included the following information:
- An End of Phase 2 meeting for NBI-1117568 (NBI-’568, an oral, muscarinic M4 selective agonist) has been completed with the US Food & Drug Administration and Neurocrine reiterated its intentions to begin Phase 3 registrational studies in schizophrenia in 1H 2025.
- Neurocrine is expected to initiate a Phase 2 study with NBI-’568 in bipolar mania, a mental health condition that causes extreme mood swings, in 2H 2025.
- Neurocrine is expected to initiate a Phase 2 study with NBI-’570 (a dual M1 / M4 agonist) in schizophrenia in 2H 2025
- Neurocrine is advancing three other muscarinic agonist programs originating from Nxera’s proprietary NxWave™ platform targeting neurological and neuropsychiatric conditions in Phase 1 trials and anticipates receiving data readouts for all three studies during 2025. These compounds are:
- NBI-1117570 (a dual M1 / M4 agonist)
- NBI-1117567 (an M1-preferring agonist)
- NBI-1117569 (an M4-preferring agonist)
Nxera and Neurocrine entered a collaboration and licensing agreement in 2021 to develop a portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera for the treatment of schizophrenia, dementia and other neuropsychiatric disorders.
NBI-’568 delivered positive Phase 2 clinical results in August 2024 and resulted in Nxera receiving a US$35 million milestone payment from Neurocrine.
Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, commented: “It is extremely encouraging to see the progress being made by Neurocrine across this exciting portfolio of muscarinic agonists and its team’s clear commitment to advancing these novel molecules towards patients. We have long believed in the potential of selective agonists of the muscarinic system to transform the treatment of neurological and neuropsychiatric conditions and look forward reporting further progress over the coming years.”
Chris Cargill, President and CEO of Nxera, will present at the J.P. Morgan Healthcare Conference on Wednesday, 15 January 2025 at 3:00 p.m. PST. Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink. Presentation slides will be made available through the investor section of the Company’s website.
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About Nxera Pharma
Nxera Pharma 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 Relations
Kentaro Tahara, VP Investor Relations and Corporate Strategy
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
Maya Bennison, Communications Manager
+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life
MEDiSTRAVA (for International Media)
Mark Swallow, Frazer Hall, Erica Hollingsworth
+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.
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