Neuron23, a clinical-stage biotechnology company developing precision medicines for Parkinson’s disease, announced it received a $2.5 million grant from The Michael J. Fox Foundation for Parkinson’s Research to support the expansion of its ongoing Phase 2 NEULARK clinical trial of NEU-411 into Israel.
The funding will support the activation of four clinical trial sites across Israel and patient screening efforts for people with early Parkinson’s disease who may have LRRK2-driven disease. Neuron23 recently screened the first patient in Israel for participation in the NEULARK study.
The global Phase 2 NEULARK clinical trial is evaluating NEU-411, a potent, selective, and brain-penetrant oral LRRK2 inhibitor, in people with early-stage Parkinson’s disease who are genetically identified as having LRRK2-driven disease. NEULARK is among the first Parkinson’s disease studies to use a precision medicine approach by prospectively identifying patients most likely to benefit from LRRK2 inhibition.
The trial is currently enrolling participants globally and uses digital biomarker technology to frequently monitor motor and non-motor symptoms of Parkinson’s disease over time. The NEULARK trial includes clinical sites in Tel Aviv, Jerusalem, and Haifa.
The randomized, double-blind, placebo-controlled study is designed to enroll about 150 participants globally, who will receive NEU-411 or a placebo daily for a 52-week treatment period. The trial incorporates a smartphone equipped with proprietary software developed by Roche Information Solutions to frequently measure Parkinson’s disease symptoms, such as movement and tremor, along with non-motor symptoms, such as cognition.
The primary endpoint is the change from baseline in the Roche digital biomarker score compared to placebo. Secondary outcome measures include the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale, a widely used tool for evaluating Parkinson’s symptoms.
Neuron23 has also partnered with Sano Genetics to streamline patient referrals and help identify people with Parkinson’s disease who may be eligible for the NEULARK trial. Under a separate protocol, Sano is offering free saliva test kits for eligible individuals that can identify LRRK2-driven Parkinson’s disease. Identified individuals will be referred to the nearest NEULARK clinical trial site for a complete eligibility evaluation and potential enrollment.
LRRK2 mutations are among the most common genetic causes of Parkinson’s disease, affecting about 2% of people with the disease. Neuron23 also said it has identified single-nucleotide polymorphisms that are predicted to drive LRRK2 overactivity in up to 30% of people with idiopathic Parkinson’s disease. People with these SNPs, together with those who have LRRK2 gene mutations, make up the population Neuron23 refers to as LRRK2-driven Parkinson’s disease.
NEU-411 is designed to inhibit the overactive LRRK2 kinase pathway and address an underlying cause of disease in people with LRRK2-driven Parkinson’s disease. Neuron23 believes this approach could offer a more precise and potentially more effective option compared to existing treatments that only address some symptoms of Parkinson’s disease.
KEY QUOTES:
“Support from The Michael J. Fox Foundation underscores the growing momentum behind precision medicine approaches in Parkinson’s disease. We believe identifying and treating patients based on the underlying biology driving their disease has the potential to fundamentally change how Parkinson’s disease is treated. Israel has an exceptional Parkinson’s research and clinical community, and we are excited to expand NEULARK to patients there.”
Arash Rassoulpour, Ph.D., Chief Operating Officer of Neuron23
“LRRK2 remains one of the most compelling therapeutic targets in Parkinson’s disease because it is supported by decades of genetic and biological research. The expansion of precision medicine studies like NEULARK into Israel reflects the strong commitment of the movement disorders community to provide access to clinical trials and prospective future targeted therapies in Israel and worldwide.”
Prof. Roy Alcalay, M.D., Chief of the Movement Disorders Division at Tel Aviv Sourasky Medical Center
“At The Michael J. Fox Foundation, we remain steadfast toward our singular and urgent mission of delivering better treatments and a cure for patients living with Parkinson’s disease. We’re moving toward a future where we can define disease by biology, identify it earlier and build more targeted treatments. Our support of Neuron23’s expanded recruitment efforts reflects the field’s growing momentum in more personalized drug development and the importance of studying therapies in genetically enriched patient populations.”
Shalini Padmanabhan, PhD, Senior Vice President and Head of Translational Research at The Michael J. Fox Foundation
