Tokyo, Japan and Cambridge, UK, 6 December 2023 – Sosei Group Corporation (“the Company”; TSE: 4565), notes its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, has confirmed its plans to evaluate two new muscarinic agonist candidates in Phase 1 first-in-human clinical studies. The studies are designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-1117569 and NBI-1117567 in healthy adult participants. NBI-1117569, a muscarinic M4-preferring agonist, and NBI-1117567, a muscarinic M1-preferring agonist are both investigational, oral compounds, which may have the potential to treat neurological and neuropsychiatric conditions and were developed utilizing Sosei Heptares' structure-based drug design platform. Neurocrine confirmed a Phase 1 clinical study of NBI-1117569 has started and a Phase 1 study of NBI-1117567 will be initiated in 2024.
Matt Barnes, President of Heptares Therapeutics and Head of UK R&D, said: “We are delighted that Neurocrine is progressing these unique M4-preferring and M1-preferring agonists into clinical development to target important unmet medical needs in neurological and neuropsychiatric disorders. NBI-1117569 and NBI-1117567 are the third and fourth candidates to advance into clinical trials from the portfolio of selective muscarinic receptor agonists discovered and licensed by Sosei Heptares to Neurocrine in 2021. Neurocrine has the largest portfolio of muscarinic compounds in clinical development, and we look forward to future progress under this highly productive partnership, including the Phase 2 clinical data on NBI-1117568, a muscarinic M4 selective agonist, expected in the second half of 2024.”
The clinical development milestones achieved with both compounds as announced do not trigger a milestone payment from Neurocrine to Sosei Heptares 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. Sosei Heptares will announce the receipt of any milestone payments in accordance with TSE reporting requirements.
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 the Agreement with Neurocrine Biosciences
Sosei Heptares 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 Sosei Heptares. Neurocrine is responsible for development costs associated with the programs globally, except for M1 agonists being developed in Japan. Sosei Heptares retains rights to develop M1 agonists in Japan for any indication, with Neurocrine receiving co-development and profit share options.
Sosei Heptares 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, Parkinson’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, and Facebook.
*in collaboration with AbbVie
NEUROCRINE and the Neurocrine logo are registered trademarks of Neurocrine Biosciences, Inc.