Laguna and Neurocrine advance schizophrenia diagnostic and treatment programs
Laguna won FDA Breakthrough Device Designation for a blood-based schizophrenia test, while Neurocrine dosed the first patient in a Phase 2 trial of NBI-1117570.
Laguna Diagnostics secured Breakthrough Device Designation from the US FDA for its mRNA Gene Biomarker Test, a blood-based assay to diagnose schizophrenia and bipolar I disorder in symptomatic patients, while Neurocrine Biosciences initiated and dosed the first patient in a Phase 2 clinical study of NBI-1117570 in adults with schizophrenia. The developments address diagnosis and treatment in a serious and complex syndrome with heterogeneous symptoms.
Laguna’s test analyzes mRNA biomarker signatures from a standard venous blood sample to generate an objective probability score designed to help distinguish between schizophrenia and bipolar I disorder. It is intended to complement—not replace—clinical judgment and other diagnostic inputs.
As part of the FDA Breakthrough Device process, Laguna was required to reanalyze pivotal study data using a locked diagnostic algorithm and FDA-suggested modifications. The results reported 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy. Laguna said the test is still undergoing further clinical validation and remains under active development within the FDA Breakthrough Device program.
The Phase 2 study of NBI-1117570 is a double-blind, placebo-controlled trial designed to evaluate the efficacy, safety and tolerability of the investigational oral, dual muscarinic M1/M4 selective receptor agonist in adult patients with schizophrenia requiring in-patient treatment. The study is expected to enroll approximately 120 patients. The primary endpoint is change from baseline in the Positive and Negative Syndrome Scale total score, and the key secondary endpoint is treatment-emergent adverse events.
NBI-1117570 was discovered using Nxera’s proprietary NxWave drug discovery platform, and Nxera said it will receive milestone payments of US$22.5 million from Neurocrine pursuant to the agreement, with the payments to be recognised as revenue in Q1 FY2026. Neurocrine acquired the rights to develop and commercialize NBI-1117570 from Nxera.
The World Health Organization estimates that schizophrenia impacts approximately 24 million people worldwide. Annual associated costs for schizophrenia are estimated to be more than $150 billion in the United States.