Sosei Heptares' partner Neurocrine Biosciences Initiates Phase 1 Clinical Study Evaluating Effects of NBI-1117570 in Healthy Adults
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.
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 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, ith further product royalties, provided the criteria under the agreement are satisfied.
About Neurocrine Biosciences
NEUROCRINE and the Neurocrine logo are registered trademarks of Neurocrine Biosciences, Inc.
About Sosei Heptares
Our global business combines our world-leading GPCR-targeted StaR® technology, structure-based drug design and early development capabilities in the UK with a highly experienced clinical development capability and a commercial operation in Japan.
We are leveraging these capabilities to generate and advance a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases. We intend to develop these opportunities for patients in Japan and globally both internally and through our partnerships with global biopharmaceutical companies and emerging technology companies.
Sosei Heptares operates from key locations in Tokyo and Osaka (Japan), London and Cambridge (UK) and Seoul (South Korea).
“Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are trademarks of Sosei Group companies.
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