The successful completion of the preclinical toxicity program for NBI-1117568, an oral M4 receptor agonist, marks a crucial step in its journey toward treating schizophrenia and neuropsychiatric disorders, the companies say.
As it advances through phase 2 trials, hopes are high for this innovative therapy in addressing critical unmet needs in mental health. Achieveing this and meeting US FDA requirements for safe, chronic dosing, triggers a significant $15 million payment to Nxera (formerly Sosei Group) from Neurocrine.
NBI-1117568 is part of a broader portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1, and dual M1/M4 receptor agonists developed by Nxera and progressing under a global collaboration established in 2021 with Neurocrine.
Schizophrenia and other neurological diseases
Matt Barnes, EVP, president of Nxera Pharma UK and head of R&D, said: “We are delighted that NBI-1117568 has successfully achieved this important safety development milestone. These results will support the safe, long-term use of this novel clinical candidate, which is consistent with a desired product profile for schizophrenia and other neurological diseases where patients often need therapy over many years.
“We are extremely pleased at the progress being made under our highly productive partnership with Neurocrine and look forward to reporting further progress and upcoming clinical data readouts, including the top-line Phase 2 data on NBI-1117568, which is expected in the second half of 2024.”
Nxera retains rights to develop M1 agonists in Japan, an aspect emphasized by Barnes. The partnership with Neurocrine aims to address major unmet medical needs in neurological disorders by targeting selective activation of M4 and M1 receptors in the brain, offering potential blockbuster treatments.
NBI-1117568, as an oral, selective muscarinic M4 receptor agonist, represents a promising therapeutic avenue for schizophrenia and other neuropsychiatric disorders. The drug, discovered by Nxera, aims to deliver therapeutic effects without the need for combination therapy to minimize side effects typically associated with non-selective muscarinic agonists.
FDA-approved treatments
The collaboration with Neurocrine, initiated in November 2021, includes a broad portfolio of novel muscarinic receptor agonists. Neurocrine has global development and commercialization rights for these candidates, with Nxera retaining development rights for M1 agonists in Japan, underscoring the collaborative nature of the agreement.
Neurocrine Biosciences, a neuroscience-focused biopharmaceutical company, says it is dedicated to developing life-changing treatments for neurological, neuroendocrine, and neuropsychiatric disorders. Their diverse portfolio includes FDA-approved treatments and a robust pipeline of compounds in mid- to late-phase clinical development, aligning with Nxera's mission to address unmet needs in neurological disorders.
Through their collaboration, Nxera and Neurocrine said they aim to alleviate suffering and provide innovative treatments for patients with neurological conditions, demonstrating their commitment to advancing neuroscience research and therapeutic solutions.
