India Pharma Outlook Team | Tuesday, 03 September 2024
Nxera Pharma Co., Ltd. is set to get a US$35 million payout from Neurocrine Biosciences (‘Neurocrine’) for the Phase 2 trial success with NBI-1117568 (NBI-‘568) in adults with schizophrenia, as disclosed on 28 August 2024. Recognition of the US$35 million payment will be acknowledged as a singular revenue in the third quarter of 2024.
The study on NBI-'568-SCZ2028 to determine the appropriate dose was successful at the 20 mg once-daily dose and showed overall safety and tolerability across all doses tested, which aligns with Neurocrine's plans to move NBI-'568 into Phase 3 clinical trials in early 2025. For more information on the positive results from the trial, please see the announcement titled "Nxera Pharma Notes Positive Phase 2 Data for Partnered Schizophrenia Candidate NBI-1117568" released on 28 August 2024.
NBI-’568 is currently being developed as the first oral medication targeting the muscarinic M4 receptor specifically for treating schizophrenia. The candidate, discovered by Nxera and progressing in a 2021 global collaboration with Neurocrine, is the most cutting-edge among a wide range of new clinical and preclinical subtype-specific muscarinic M4, M1, and dual M1/M4 receptor agonists for treating significant neurological and neuropsychiatric disorders.
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."