Nxera Pharma provides update on Neurocrine’s progress with its partnered muscarinic agonist portfolio
Tokyo, Japan and Cambridge, UK, 14 January 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) is pleased to report on progress being made by Neurocrine Biosciences, Inc. (“Neurocrine”) regarding the clinical development of its partnered muscarinic agonist portfolio. These updates were presented by Neurocrine at the 43rd Annual J.P. Morgan Healthcare Conference. The update presented by Neurocrine included the following information:
- An End of Phase 2 meeting for NBI-1117568 (NBI-’568, an oral, muscarinic M4 selective agonist) has been completed with the US Food & Drug Administration and Neurocrine reiterated its intentions to begin Phase 3 registrational studies in schizophrenia in 1H 2025.
- Neurocrine is expected to initiate a Phase 2 study with NBI-’568 in bipolar mania, a mental health condition that causes extreme mood swings, in 2H 2025.
- Neurocrine is expected to initiate a Phase 2 study with NBI-’570 (a dual M1 / M4 agonist) in schizophrenia in 2H 2025
- Neurocrine is advancing three other muscarinic agonist programs originating from Nxera’s proprietary NxWave™ platform targeting neurological and neuropsychiatric conditions in Phase 1 trials and anticipates receiving data readouts for all three studies during 2025. These compounds are:
- NBI-1117570 (a dual M1 / M4 agonist)
- NBI-1117567 (an M1-preferring agonist)
- NBI-1117569 (an M4-preferring agonist)
Nxera and Neurocrine entered a collaboration and licensing agreement in 2021 to develop a portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera for the treatment of schizophrenia, dementia and other neuropsychiatric disorders.
NBI-’568 delivered positive Phase 2 clinical results in August 2024 and resulted in Nxera receiving a US$35 million milestone payment from Neurocrine.
Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, commented:
It is extremely encouraging to see the progress being made by Neurocrine across this exciting portfolio of muscarinic agonists and its team’s clear commitment to advancing these novel molecules towards patients. We have long believed in the potential of selective agonists of the muscarinic system to transform the treatment of neurological and neuropsychiatric conditions and look forward reporting further progress over the coming years.
Chris Cargill, President and CEO of Nxera, will present at the J.P. Morgan Healthcare Conference on Wednesday, 15 January 2025 at 3:00 p.m. PST.
