Pharma Focus Europe

Neurocrine Biosciences, Partnering With Sosei Heptares, Launches Phase 1 Clinical Study to Investigate NBI-1117570 Effects in Healthy Adults

Tuesday, September 12, 2023

Sosei Group Corporation (TSE: 4565) has been informed by its partner, Neurocrine Biosciences Inc. (Nasdaq: NBIX), a prominent neuroscience-focused biopharmaceutical firm, that it has initiated a Phase 1 clinical study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the investigational compound NBI-1117570 in healthy adult participants. NBI-1117570 is an investigational oral muscarinic M1/M4 selective dual agonist developed through Sosei Heptares' structure-based drug design platform, with potential applications in neurological and neuropsychiatric conditions.

Dr. Eiry W. Roberts, Chief Medical Officer at Neurocrine Biosciences, emphasized the significance of this Phase 1 study, stating that NBI-1117570, as a potential first-in-class dual M1/M4 agonist, may offer a novel approach to addressing symptoms of psychosis and cognition across a wide spectrum of neurological and neuropsychiatric disorders.

Matt Barnes, President of Heptares Therapeutics and Head of UK R&D, expressed enthusiasm for Neurocrine's advancement of this unique compound into clinical development. NBI-1117570 represents the second candidate to progress to clinical trials from the portfolio of muscarinic receptor agonists discovered and licensed by Sosei Heptares to Neurocrine in 2021.

It's important to note that the initiation of this Phase 1 study does not trigger a milestone payment from Neurocrine to Sosei Heptares, as specified in their 2021 agreement. Milestone payments will be made upon the achievement of specific development milestones for each program, and any such payments will be reported by Sosei Heptares in accordance with TSE reporting requirements.

NBI-1117570 is an investigational oral compound with dual muscarinic M1/M4 agonist activity. These muscarinic receptors play a crucial role in activating signaling pathways in the brain. NBI-1117570 selectively targets two of the five muscarinic acetylcholine receptors (M1 and M4), with M1 identified as a potential target for cognition and M4 for psychosis in clinical drug development. Neurocrine Biosciences holds the rights for the development and commercialization of NBI-1117570, acquired from Sosei Heptares.

Sosei Heptares and Neurocrine Biosciences entered into a collaboration and licensing agreement in November 2021 to develop novel muscarinic receptor agonists for the treatment of conditions like schizophrenia, dementia, and other neuropsychiatric disorders.

According to the terms of the agreement, Neurocrine has gained global development and commercialization rights for a diverse portfolio of 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 these programs worldwide, except for M1 agonists developed in Japan. Sosei Heptares retains the rights to develop M1 agonists in Japan for any indication, with Neurocrine having co-development and profit-sharing options.

Sosei Heptares is eligible to receive funding for research and development, as well as development, regulatory, and commercialization milestone payments totaling up to US$2.6 billion, in addition to product royalties, subject to meeting the criteria outlined in the agreement.

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