- NEU-411, a brain-penetrant, potent and selective kinase inhibitor, has potential to slow disease progression in up to 30% of people with LRRK2-driven Parkinson’s disease
- Global Phase 2 clinical trial leverages Roche-developed digital biomarker as primary endpoint for enhanced precision and efficiency over traditional clinical rating scales
- Collaborations with QIAGEN, Sano Genetics and Quest Diagnostics to streamline trial referrals and stratify patient subsets to identify those more likely to respond to treatment
- Company to initiate trial in early 2025, serving as major, value-creating catalyst for continued innovation across Neuron23’s neuroimmunology pipeline
19 November, 2024: Neuron23 Inc. has announced the Phase 2 NEULARK clinical trial of NEU-411, a brain-penetrant LRRK2 inhibitor, targeting early-stage Parkinson’s disease (PD). The trial employs precision medicine strategies, focusing on individuals with LRRK2-driven PD, who may represent up to 30% of the PD population. This population includes those with familial LRRK2 mutations and idiopathic PD patients with specific single-nucleotide polymorphisms (SNPs) driving LRRK2 overactivity.
NEU-411, previously shown to be safe and well-tolerated in Phase 1 trials, demonstrated robust LRRK2 inhibition via fluid-based biomarkers and strong preclinical safety data. Unlike current PD treatments addressing symptoms only, NEU-411 targets a key driver of disease progression, offering a potentially transformative therapy for this subgroup.
The NEULARK trial is a global, double-blind, placebo-controlled study with a rigorous patient stratification process. Collaborating with QIAGEN and Quest Diagnostics, Neuron23 has developed an exome-based assay to identify LRRK2-driven PD candidates through next-generation sequencing and predictive algorithms. Sano Genetics is further facilitating patient recruitment by providing genetic testing and counselling.
Disease progression will be monitored using Roche Diagnostics’ advanced digital biomarker, which integrates seamlessly into daily life via smartphone technology. This innovative tool assesses motor and non-motor symptoms, providing precise, continuous data that surpasses traditional in-clinic evaluations.
Neuron23 anticipates launching NEULARK in early 2025, with the potential to redefine PD clinical trial methodology and therapeutic development. By combining genetic insights, advanced diagnostics, and cutting-edge digital monitoring, the trial represents a significant milestone in precision medicine for neurodegenerative diseases.
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