Neuron23 Secures $2.5 Million Grant from The Michael J. Fox Foundation to Expand Precision Medicine Parkinson’s Trial into Israel
Neuron23 Inc., a clinical-stage biotechnology company focused on advancing precision medicine approaches for Parkinson’s disease, has received a $2.5 million grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to support the expansion of its ongoing Phase 2 NEULARK clinical trial into Israel. The funding marks an important step in the company’s efforts to broaden global participation in the study and accelerate the development of targeted therapies for individuals living with Parkinson’s disease.
The grant will help establish additional clinical research infrastructure in Israel, including the activation of four clinical trial sites and expanded patient screening initiatives aimed at identifying individuals with early-stage Parkinson’s disease whose condition may be driven by alterations in the LRRK2 gene. The expansion represents a significant milestone for Neuron23’s precision medicine strategy, which seeks to match treatments to the biological mechanisms underlying disease progression.
The company recently reached another important achievement when the first patient in Israel was screened for participation in the NEULARK study. This development signals the beginning of a broader recruitment effort that is expected to enhance patient access to cutting-edge research opportunities while generating valuable clinical data from a geographically diverse participant population.
Advancing Precision Medicine in Parkinson’s Disease
The support from The Michael J. Fox Foundation reflects growing enthusiasm within the Parkinson’s disease research community for precision medicine approaches that move beyond traditional treatment strategies.
Historically, Parkinson’s disease has been treated largely as a single disorder despite increasing evidence that multiple biological pathways contribute to its development and progression. Researchers now recognize that different genetic and molecular drivers may influence disease onset, symptoms, and treatment response among patients.
Precision medicine aims to address this complexity by identifying specific biological mechanisms responsible for disease in individual patients and developing therapies that directly target those pathways.
According to Arash Rassoulpour, Ph.D., Chief Operating Officer of Neuron23, the grant highlights the increasing momentum behind this personalized approach to Parkinson’s disease treatment.
Rassoulpour noted that identifying and treating patients based on the biological factors driving their disease could fundamentally transform how Parkinson’s disease is managed in the future. He emphasized that the company views precision medicine as a pathway toward more effective and targeted therapies capable of delivering improved outcomes for patients.
He also highlighted Israel’s strong scientific and clinical research ecosystem, noting that the country has long been recognized for excellence in neuroscience research, movement disorder care, and clinical trial participation. Expanding the NEULARK study into Israel provides an opportunity to collaborate with leading investigators while increasing access to innovative treatment options for patients.
Understanding the Role of LRRK2 in Parkinson’s Disease
At the center of the NEULARK study is the investigation of a specific biological target known as leucine-rich repeat kinase 2, or LRRK2.
Mutations and variations in the LRRK2 gene are among the most common known genetic contributors to Parkinson’s disease. Research over the past two decades has established a strong connection between abnormal LRRK2 activity and the development of neurodegenerative processes associated with the condition.
The gene encodes a protein involved in several important cellular functions, including signaling pathways, protein transport, and cellular maintenance processes. When LRRK2 activity becomes dysregulated, it can contribute to neuronal dysfunction and degeneration, ultimately leading to Parkinson’s disease symptoms.
Because of the extensive genetic and biological evidence supporting its role in disease development, LRRK2 has emerged as one of the most promising therapeutic targets in Parkinson’s research.
Scientists believe that therapies capable of modulating LRRK2 activity may slow disease progression or potentially alter the underlying disease process rather than simply addressing symptoms.
This possibility has generated significant interest among researchers, biotechnology companies, and patient advocacy organizations seeking to develop disease-modifying treatments for Parkinson’s disease.
NEU-411: A Targeted Investigational Therapy
The NEULARK clinical trial is evaluating NEU-411, Neuron23’s investigational oral LRRK2 inhibitor designed specifically for patients whose Parkinson’s disease is driven by LRRK2-related biological mechanisms.
NEU-411 has been engineered to be potent, selective, and capable of penetrating the brain effectively, characteristics considered essential for targeting neurodegenerative disease pathways.
By selectively inhibiting LRRK2 activity, the therapy aims to address one of the underlying biological drivers of disease rather than merely alleviating symptoms such as tremor, stiffness, or impaired movement.
The drug is currently being evaluated in individuals with early-stage Parkinson’s disease who have been genetically identified as having LRRK2-driven disease. This targeted enrollment strategy distinguishes the NEULARK study from many previous Parkinson’s disease trials, which often included broad patient populations without consideration of specific genetic factors.
Neuron23 believes that focusing on genetically defined patient groups may increase the likelihood of detecting meaningful treatment effects and improve the overall efficiency of clinical development.
A Landmark Precision Medicine Study
The global Phase 2 NEULARK trial is among the first Parkinson’s disease studies designed around a prospective precision medicine framework.
Rather than enrolling patients solely on the basis of clinical symptoms, researchers are actively identifying participants who possess genetic markers indicating that LRRK2 dysfunction may be a primary driver of their disease.
This approach mirrors successful precision medicine strategies that have transformed treatment development in oncology and several rare genetic disorders.
By selecting patients most likely to benefit from a targeted therapy, investigators hope to improve clinical outcomes while gaining a deeper understanding of disease biology.
The study is currently recruiting participants across multiple international locations and continues to expand its global footprint. The addition of Israeli research sites further strengthens the trial’s ability to enroll eligible patients and collect data across diverse populations.
Researchers believe that such diversity is essential for evaluating treatment effectiveness and ensuring that future therapies can benefit broad patient communities around the world.
Integrating Digital Biomarkers into Clinical Research
One of the distinguishing features of the NEULARK study is its incorporation of digital biomarker technology to monitor disease progression and treatment response.
Traditional Parkinson’s disease assessments often rely on periodic clinic visits during which physicians evaluate symptoms using standardized rating scales. While valuable, these assessments can provide only limited snapshots of a patient’s condition.
Digital biomarker technologies offer the opportunity to collect more frequent and continuous information about disease activity.
Through wearable devices and digital monitoring tools, researchers can assess both motor symptoms—such as tremor, gait abnormalities, and movement impairment—and non-motor symptoms, including sleep disturbances, cognitive changes, and other aspects of daily functioning.
This richer dataset may provide a more comprehensive understanding of disease progression and enable investigators to detect subtle treatment effects that might otherwise go unnoticed.
The integration of digital health technologies aligns with broader trends in clinical research aimed at generating real-world insights while improving patient engagement and trial efficiency.
Israel’s Growing Role in Parkinson’s Research
The expansion of NEULARK into Israel reflects the country’s growing importance in neurological research and clinical innovation.
Israel is home to a highly regarded network of academic medical centers, neuroscience researchers, and movement disorder specialists who have contributed significantly to Parkinson’s disease research.
The NEULARK study includes clinical trial sites in major medical centers located in Tel Aviv, Jerusalem, and Haifa, providing access to patients across several regions of the country.
Professor Roy Alcalay, M.D., Chief of the Movement Disorders Division at Tel Aviv Sourasky Medical Center, emphasized the scientific importance of targeting LRRK2 in Parkinson’s disease.
According to Alcalay, decades of genetic and biological research have established LRRK2 as one of the most compelling therapeutic targets in the field. He noted that the expansion of precision medicine studies such as NEULARK demonstrates the movement disorders community’s commitment to advancing targeted therapies and increasing patient access to innovative clinical research opportunities.
He added that broad participation in studies like NEULARK is critical for building the evidence necessary to support future precision medicine treatments for patients both in Israel and around the world.
The Michael J. Fox Foundation’s Continued Commitment
The Michael J. Fox Foundation remains one of the world’s leading organizations dedicated to accelerating Parkinson’s disease research and advancing the development of better treatments and ultimately a cure.
The foundation’s decision to support Neuron23’s expansion efforts reflects its strategic focus on advancing biologically driven approaches to disease understanding and drug development.
Shalini Padmanabhan, Ph.D., Senior Vice President and Head of Translational Research at MJFF, highlighted the organization’s commitment to moving the field toward a future where Parkinson’s disease can be defined by underlying biology rather than symptoms alone.
She emphasized that researchers are increasingly working toward identifying disease earlier, understanding individual disease drivers, and developing therapies tailored to specific patient populations. Supporting Neuron23’s recruitment and expansion efforts aligns with these goals and reflects the broader momentum toward personalized medicine in neurodegenerative disease research.
As patient recruitment continues and additional Israeli sites become fully operational, the NEULARK trial is expected to play an important role in evaluating whether targeted inhibition of LRRK2 can provide meaningful clinical benefits for patients with genetically defined Parkinson’s disease.
The combination of genetic patient selection, innovative digital biomarker technologies, and international collaboration positions the study at the forefront of precision medicine research in neurology.
For Neuron23, the support from The Michael J. Fox Foundation represents more than financial assistance—it serves as validation of the company’s scientific approach and its vision of transforming Parkinson’s disease treatment through personalized therapeutic strategies.
If successful, NEU-411 and the NEULARK program could help pave the way for a new generation of precision therapies that address the root biological causes of Parkinson’s disease, offering hope for more effective and individualized treatment options for patients worldwide.
About NEULARK
The global Phase 2 NEULARK clinical trial (NCT06680830) is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of orally administered NEU-411 in people with early-stage, LRRK2-driven PD. The trial is designed to enroll approximately 150 participants globally, who will receive NEU-411 or placebo daily for a 52-week treatment period.
The trial incorporates a smartphone equipped with proprietary software developed by Roche Information Solutions (RIS) that frequently measures PD symptoms such as movement and tremor, as well as 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 (MDS-UPDRS), a widely recognized tool for evaluating Parkinson’s symptoms.
Neuron23 has partnered with Sano Genetics to streamline patient referrals and assist in the identification of people with PD who may be eligible to participate in the NEULARK clinical trial. Under a separate protocol, Sano is offering free saliva test kits for eligible individuals that can identify LRRK2-driven PD. Individuals identified will be referred to the nearest NEULARK clinical trial site for a complete eligibility evaluation and potential enrollment. More information can be found at https://neulark.com.
About LRRK2-Driven Parkinson’s Disease and NEU-411
Mutations in the LRRK2 gene are among the most common genetic causes of PD, affecting approximately 2% of people with the disease. Individuals who inherit gain-of-function mutations in LRRK2 are at higher risk of developing PD later in life. Importantly, there is a growing body of evidence that LRRK2 activity may play a role in a subset of the larger population of people without a family history of PD, known as idiopathic PD, suggesting that therapies targeting LRRK2 could be beneficial to a broader population than just individuals with rare, familial LRRK2 mutations.
Neuron23 has identified single-nucleotide polymorphisms (SNPs) – variations in an individual’s DNA sequence – that are predicted to drive LRRK2 overactivity in up to 30% of people with idiopathic PD. People with PD who have these SNPs, together with those who have LRRK2 gene mutations, make up the population collectively referred to as LRRK2-driven PD and represent who Neuron23 believes are most likely to benefit from LRRK2 inhibition.
NEU-411 is a potent, highly selective and brain-penetrant oral LRRK2 inhibitor with best-in-class potential. By specifically inhibiting the overactive LRRK2 kinase pathway, NEU-411 aims to address an underlying cause of disease in people with LRRK2-driven PD, offering a more precise and potentially more effective approach compared to existing treatment options that only address some symptoms of PD.
About Parkinson’s Disease
Parkinson’s disease (PD) is a brain disorder that causes impaired movements, such as shaking, stiffness and difficulty with balance and coordination. Symptoms usually begin gradually and worsen over time. As the disease progresses, people may have difficulty walking and talking. Additional symptoms can include cognitive and behavioral changes, such as sleep problems, depression, memory difficulties and fatigue.
Some cases of PD appear to be hereditary, and a few cases can be traced to specific genetic mutations. Currently, there is no available cure or therapy that impacts underlying PD progression, and treatment options are only used to alleviate some symptoms.
About Neuron23®
Neuron23 Inc. is a clinical-stage biotechnology company focused on developing precision medicines for Parkinson’s disease. By combining advances in human genetics, data science and a patient-centered clinical approach, Neuron23 is developing targeted therapies designed to address the underlying biology driving disease progression in genetically defined patient populations. The Company’s lead program, NEU-411, is being evaluated in the global Phase 2 NEULARK clinical trial for people with LRRK2-driven Parkinson’s disease. Founded in 2018, Neuron23 is headquartered in South San Francisco, California.
