Tokyo, Japan and Cambridge, UK, 12 September 2023 – Sosei Group Corporation (“the Company”; TSE: 4565), has been notified by its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, that it has initiated its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117570 in healthy adult participants. NBI-1117570 is an investigational, oral, muscarinic M1/M4 selective dual agonist that may have the potential to treat neurological and neuropsychiatric conditions and was developed utilising Sosei Heptares' structure-based drug design platform.
“Initiation of this Phase 1 study represents an important step forward for NBI-1117570, a potentially first-in-class, orally active, selective investigational dual M1/M4 agonist,” said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "The selectivity profile of NBI-1117570 in targeting M1 and M4 receptors may provide an opportunity to treat symptoms of both psychosis and cognition across a broad range of neurological and neuropsychiatric conditions.”
Matt Barnes, President of Heptares Therapeutics and Head of UK R&D, said: “We are delighted that Neurocrine is progressing this unique M1/M4 selective agonist into clinical development to target important unmet medical needs in neurological and neuropsychiatric disorders. NBI-1117570 is the second candidate to advance into clinical trials from the portfolio of selective muscarinic receptor agonists discovered and licensed by Sosei Heptares to Neurocrine in 2021. We look forward to reporting further progress from these and potentially other candidates under this highly productive partnership.”
The clinical development milestone achieved with NBI-1117570 as announced does 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.
NBI-1117570 is an investigational, oral, muscarinic M1/M4 dual agonist. Muscarinic receptors are fundamental to activating signaling pathways in the brain. There are five muscarinic acetylcholine receptors involved in neurotransmission, two of which are selectively targeted by NBI-1117570 (M1 and M4), with M1 validated as a potential drug target in cognition and M4 in psychosis for clinical drug development. Neurocrine Biosciences acquired the rights to develop and commercialize NBI-1117570 from Sosei Heptares.
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, Twitter, and Facebook.
*in collaboration with AbbVie
NEUROCRINE and the Neurocrine logo are registered trademarks of Neurocrine Biosciences, Inc.