Sosei Group Co., Ltd.
Announcement of the start of a Phase I clinical trial of NBI-1117570 in healthy adults by our partner Neurocrine, Inc.
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Takeda has evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-1117570 from Neurocrine Biosciences Inc. (Nasdaq: NBIX), a leading biotechnology company specializing in neurological diseases. We would like to inform you that we have started a Phase I clinical trial on healthy adults. NBI-1117570 is an oral muscarinic M1/M4 dual receptor agonist that is expected to be a treatment for neurological and neuropsychiatric disorders.
Eiry W. Roberts, M.D., chief medical officer (CMO), Neurocrine, said, “The initiation of a Phase I clinical trial of NBI-1117570 represents an important step forward for this potentially first-in-class orally available dual M1/M4 receptor agonist. Selectivity has the potential to treat both psychiatric and cognitive symptoms in a wide range of neurological and neuropsychiatric disorders.”
Matt Burns, President and Head of UK Research and Development at Heptares Therapeutics, said: “NBI-1117570 will be available at Neurocline in 2021 to advance clinical development of a dual M1/M4 receptor agonist to address significant unmet medical needs in neurological and neuropsychiatric diseases. We are the second in our portfolio of muscarinic receptor agonists to enter clinical trials, out-licensed at We look forward to reporting further developments.” Please note that there are no milestone payments associated with this release. The Company may receive milestones related to the Phase I clinical trial under NBI-1117570, the terms of which will be determined in a separate agreement. We will keep you informed of any such developments in the future.
NBI-1117570 is an oral muscarinic M1/M4 dual receptor agonist. Muscarinic receptors play an important role in the activation of signal transduction pathways in the brain. There are five subtypes of muscarinic acetylcholine receptors involved in neurotransmission, and selective action on two of them (M1 and M4) is clinically effective as a drug target for cognitive function (M1) and for psychosis (M4). This is an approach that is being evaluated. Neurocline has acquired the rights to research, develop, and commercialize NBI-1117570 from our group.
About the contract with Neurocline
In November 2021, the Group and Neurocline entered into a strategic agreement regarding a novel muscarinic receptor agonist, with the aim of Neurocline developing drugs for the treatment of schizophrenia, dementia, and other neuropsychiatric disorders. We have concluded a research and development partnership and license agreement.
Under this agreement, Neurocline will acquire novel subtype-selective muscarinic M4, M1 and M1/M4 dual-molecular drugs that the Group has discovered and are developing and in clinical and preclinical stages for the treatment of major neurological diseases. We have acquired research, development and commercialization rights to a broad portfolio of receptor agonists. Neurocline will bear the global development costs associated with this program, except for the M1 receptor agonist being developed in Japan. The Group holds the rights to develop and commercialize muscarinic M1 receptor agonists for all indications in Japan, and Neurocline holds joint development and co-marketing rights for muscarinic M1 receptor agonists in Japan. Holds option rights.
Neurocline is a leading neuroscience biopharmaceutical company with a mission to alleviate suffering for people with great need and few treatment options. We are committed to discovering and developing life-changing treatments for patients with underserved neurological, neuroendocrine and neuropsychiatric disorders. Neurocline has a broad portfolio of U.S. Food and Drug Administration (FDA)-approved treatments for tardive dyskinesia, Parkinson’s disease,
endometriosis*, and uterine fibroids*, as well as multiple therapeutic areas. The company has multiple mid- to late-stage clinical programs. For the past 30 years, we have applied our unique knowledge of neuroscience and the interplay of brain and body systems to treat complex disease states. Patients with debilitating diseases and disabilities deserve the benefits of good science, and we are relentless in our search for medicines to ease their burden. For more information about Neurocrine Biosciences, please visit neurocrine.com, LinkedIn, Twitter, and Facebook. (*Joint development with AbbVie) NEUROCRINE and the Neurocline logo are registered trademarks of Neurocline, Inc. About Sosei Heptares
Our group is a complete biopharmaceutical company whose mission is to create life-changing medicines through world-leading science, and we aim to become an international leading biopharmaceutical company originating from Japan.
Our group has world-leading StaR(R) technology targeting G
protein-coupled receptors (GPCRs), structure-based drug discovery (SBDD), and early development capabilities in the UK, and experienced clinical development capabilities and We are expanding our business globally by combining it with our commercialization business. Utilizing these capabilities, we are working to create a broad pipeline of new drug candidates and accelerate research and
development in multiple therapeutic areas, including neurological diseases, immunological diseases, gastrointestinal diseases, and inflammatory diseases. Our group strives to develop medicines that create value for patients in Japan and around the world, either through in-house development or through partnerships with major global pharmaceutical companies and emerging biopharmaceutical companies. Our group operates from major locations in Tokyo, Osaka, London, Cambridge, and Seoul.
“Sosei Heptares” is the corporate brand of Sosei Group Co., Ltd. (stock code 4565), which is listed on the Tokyo Stock Exchange. “Sosei”, “Heptares”, our group’s logo and StaR(R) are trademarks or registered trademarks of our group.
For more information, please visit our homepage https://soseiheptares.com/. LinkedIn: @soseiheptaresco
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Sosei Group Co., Ltd.