Nxera Pharma’s partner Neurocrine Biosciences Initiates Phase 1 Clinical Study Evaluating Effects of NBI-1117567 in Healthy Adults

Tokyo, Japan and Cambridge, UK, 9 May 2024 – Nxera Pharma (“the Company” or “Nxera”; TSE: 4565) notes that its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, announced that it has initiated its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in healthy adult participants – see Neurocrine press announcement here.

NBI-1117567 is an investigational, oral, muscarinic M1 preferring (M1/M4) selective agonist discovered by Nxera that may have the potential to treat symptoms of cognition in patients with neurological and neuropsychiatric conditions.

The clinical development milestone achieved with this compound as announced does not trigger a milestone payment from Neurocrine to Nxera 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. Nxera will announce the receipt of any milestone payments in accordance with TSE reporting requirements.

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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 
Nxera Pharma 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 Nxera. Neurocrine is responsible for development costs associated with the programs globally, except for M1 agonists being developed in Japan. Nxera retains rights to develop M1 agonists in Japan for any indication, with Neurocrine receiving co-development and profit share options.