The NBI-’568-SCZ2028 dose-finding study met its primary endpoint for the once-daily 20 mg dose and was generally safe and well tolerated at all doses studied, supporting Neurocrine’s intentions to advance NBI-‘568 into Phase 3 clinical trials in early 2025. Please refer to “Nxera Pharma Notes Positive Phase 2 Data for Partnered Schizophrenia Candidate NBI-1117568” dated 28 August 2024 for the full announcement from Nxera on the positive data from the trial.
NBI-’568 is the first oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia. The candidate is the most advanced from a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera and advancing under a 2021 global collaboration with Neurocrine for the treatment of major neurological and neuropsychiatric disorders.
To date, Nxera has received multiple, significant payments from Neurocrine including those based on developmental progress of four candidates in clinical trials. Overall, Nxera is eligible to receive up to US$1.5 billion in development milestone payments through to approvals, plus commercial milestones, which together total up to US$2.6 billion, plus product royalties, provided the criteria under the agreement are satisfied. Nxera retains rights to develop M1 agonists advancing under this collaboration in Japan in all indications, subject to certain exceptions.
Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, commented:
“The successful Phase 2 trial with NBI-‘568 delivered positive data in adults with schizophrenia at the 20mg dose. As stated by Neurocrine, these data support advancing NBI-‘568 into Phase 3 trials that would aim to confirm its potential to become a new oral therapy option for patients with a competitive profile based on efficacy, safety and tolerability from a convenient 20mg once-daily administration.”
