Nxera Pharma’s partner, Neurocrine Biosciences, has launched a Phase 3 trial for NBI-1117568, an oral M4 selective receptor agonist, for schizophrenia treatment. This follows positive Phase 2 data reported in August 2024. NBI-1117568 is the first molecule designed using Nxera’s NxWave™ platform to reach Phase 3 trials.
This advancement is crucial because it represents a potential new treatment mechanism for schizophrenia, a debilitating mental illness impacting millions globally with limited effective therapies. The positive Phase 2 results suggest NBI-1117568 could offer improved efficacy and safety compared to existing antipsychotics, potentially addressing a significant unmet medical need and altering the treatment landscape for this disorder. This also validates Nxera’s NxWave™ platform, potentially opening doors for the development of other novel drug candidates for neuropsychiatric disorders.
The Phase 3 trial is a global, placebo-controlled study involving approximately 280 adults with schizophrenia experiencing an acute exacerbation or relapse. The primary endpoint is a reduction in the Positive and Negative Syndrome Scale (PANSS) score. The key secondary endpoint is improvement measured by the Clinical Global Impression of Severity (CGI-S) scale. Neurocrine will pay Nxera a $15 million milestone payment after dosing the first patient in the Phase 3 study. Phase 2 results indicated a statistically significant reduction in PANSS total score with the 20mg dose, along with improvements in secondary endpoints and a generally safe and well-tolerated profile. Neurocrine’s broader muscarinic portfolio includes other compounds targeting M1 and M4 receptors, licensed from Nxera, currently in earlier stages of clinical development for various neurological and psychiatric conditions.
The initiation of this Phase 3 trial signifies significant progress towards a potentially novel schizophrenia treatment. Positive results could lead to regulatory approval and market entry, offering a new therapeutic option for patients and significant revenue potential for both Nxera and Neurocrine. The progress of this trial will be closely watched by the industry, and further updates will be crucial in assessing the potential of NBI-1117568 to reshape schizophrenia care.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
