Nxera Pharma Achieves Milestone with Schizophrenia Drug Candidate NBI-1117568

Nxera Pharma Co., Ltd., a biopharmaceutical company formerly known as Sosei Group or Sosei Heptares, has announced a significant development in its partnership with Neurocrine Biosciences Inc. The company's drug candidate, NBI-1117568, an oral selective muscarinic M4 receptor agonist, has successfully completed a long-term preclinical toxicity program. This achievement is pivotal as it aligns with US FDA standards for safe, chronic dosing in upcoming clinical trials. As a result of this milestone, Nxera will receive a $15 million payment from Neurocrine.

NBI-1117568 is currently undergoing Phase 2 clinical trials for the treatment of schizophrenia and other neuropsychiatric disorders. It is part of a diverse portfolio of muscarinic M4, M1, and dual M1/M4 receptor agonists that Nxera has discovered and is advancing in collaboration with Neurocrine since 2021. These agonists are designed to treat a variety of neurological and neuropsychiatric conditions.

The successful completion of the toxicity program is a testament to the safety profile of NBI-1117568, which is crucial for long-term therapy often required for patients with schizophrenia and similar diseases. Matt Barnes, Executive Vice President and Head of R&D at Nxera Pharma UK, expressed enthusiasm about the milestone and the partnership with Neurocrine, anticipating further progress and clinical data in the near future.

Muscarinic receptors, including the M4 and M1 subtypes targeted by Nxera's candidates, are G protein-coupled receptors present in the brain and other tissues. Activating these receptors selectively has shown promise in treating cognitive symptoms of neurological diseases. However, previous attempts have been hindered by side effects due to the activation of other receptor subtypes, M2 and M3. The development of highly selective agonists for M4 and M1 without affecting M2 or M3 is therefore a significant advancement in the field.

NBI-1117568, as a selective M4 agonist, has the potential to provide therapeutic benefits without necessitating combination therapy to mitigate side effects, which is common with less selective muscarinic agonists. Clinical trials have indicated that the drug is well-tolerated.

The collaboration agreement between Nxera Pharma and Neurocrine Biosciences, established in 2021, grants Neurocrine rights to develop and commercialize the muscarinic receptor agonists discovered by Nxera. Neurocrine is responsible for global development costs, while Nxera retains rights for M1 agonists in Japan. Nxera is eligible to receive substantial R&D funding and potential milestone payments totaling up to US$2.6 billion, along with product royalties.

Neurocrine Biosciences is a renowned biopharmaceutical company focused on neuroscience, aiming to provide treatments for neurological, neuroendocrine, and neuropsychiatric disorders. The company has a history of developing FDA-approved treatments and maintains a robust pipeline of compounds in various stages of clinical development.

Nxera Pharma, with its headquarters in Tokyo and a global presence, is committed to developing specialty medicines to fulfill unmet medical needs. The company's pipeline includes over 30 programs at various stages of development, focusing on neurology, gastrointestinal, immunology, metabolic disorders, and rare diseases. Nxera's unique GPCR-targeted structure-based drug discovery platform, NxWaveTM, is instrumental in producing innovative drug candidates.

The announcement highlights the progress in the development of a novel treatment for neurological disorders and underscores the potential impact of selective muscarinic agonists in addressing significant unmet medical needs.