Phase 2 Trial of LRRK2 Inhibitor NEU-411 Expands Following Michael J. Fox Foundation Grant

In a new company update, Neuron23 announced that it has received a $2.5 million grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to support expansion of its phase 2 NEULARK trial (NCT06680830) of NEU-411 into Israel, activating 4 clinical sites across Tel Aviv, Jerusalem, and Haifa. The company noted that the first Israeli patient has been screened, advancing what is among the first Parkinson disease (PD) trials to prospectively select participants based on genetically identified LRRK2-driven disease.¹

“We were appreciative to receive support from [MJFF]. The grant represented not only important financial support for expanding NEULARK to Israel, but also validation of our scientific approach and commitment to advancing precision medicine in [PD],” Arash Rassoulpour, PhD, chief operating officer of Neuron23, told NeurologyLive^®. “Expanding into Israel provides access to a highly engaged clinical and research community, enabling us to accelerate patient enrollment, deepen our understanding of genetically defined [PD] populations, and advance the development of targeted therapies such as NEU-411.”

Trial Design and End Points

NEULARK is a randomized, double-blind, placebo-controlled study enrolling approximately 150 participants with early-stage, LRRK2-driven PD at global sites for a 52-week treatment period of orally administered NEU-411 or placebo. The primary end point is the change from baseline in a Roche digital biomarker score generated via a smartphone platform that continuously monitors motor symptoms, including tremor and gait, and nonmotor features such as cognition.

Secondary end points include the Movement Disorder Society's Unified Parkinson's Disease Rating Scale. To support enrollment, Neuron23 has partnered with Sano Genetics to offer free saliva-based LRRK2 genetic screening to identify eligible participants and refer them to the nearest trial site.

“As part of our NEULARK trial evaluating NEU-411, we employ a precision medicine strategy designed to identify and enroll patients whose disease biology is most likely to be driven by LRRK2 overactivity,” Rassoulpour added. “This patient stratification approach may help increase the likelihood of demonstrating meaningful benefit by matching the right therapy to the right patients. By targeting disease biology early and directly, NEU-411 has the potential to modify disease progression rather than simply manage symptoms.”

READ MORE: Pariceract Fails to Meet Primary End point in Phase 2b ACTIVATE Trial for GBA1-Associated Parkinson Disease

Disease Burden and Clinical Context

PD affects an estimated 10 million people worldwide and currently has no approved disease-modifying therapy; all standard-of-care options including levodopa, dopamine agonists, and deep brain stimulation target symptomatic relief without slowing underlying neurodegeneration.² LRRK2 gain-of-function mutations represent the most common known monogenic cause of PD, accounting for approximately 1–2% of sporadic cases globally.³

“One of the largest unmet needs in [PD] is the lack of therapies that can slow, stop, or prevent disease progression. While current treatments can provide meaningful symptomatic relief, they do not address the underlying neurodegenerative processes driving the disease,” Rassoulpour said to NeurologyLive. “There is also a need for better tools to identify patients based on the biological mechanisms underlying their disease, enabling more personalized treatment approaches. For patients with LRRK2-driven [PD], and potentially broader populations with elevated LRRK2 activity, targeted therapies such as NEU-411 may offer an opportunity to address these unmet needs by intervening directly in disease biology.'“

Mechanism and Drug-Class Context

NEU-411 is an oral, brain-penetrant small-molecule inhibitor of the LRRK2 kinase domain. Gain-of-function LRRK2 mutations are thought to impair lysosomal function, disrupt vesicle trafficking, and promote alpha-synuclein aggregation, pathways directly upstream of dopaminergic neuronal loss.⁴

“NEU-411 is designed to address an underlying biological driver of Parkinson’s disease rather than primarily treating symptoms. It is a selective inhibitor of LRRK2, a kinase whose increased activity has been implicated in both familial and sporadic forms of [PD]. What differentiates NEU-411 is its ability to achieve robust target engagement in both the periphery and CNS,” Rassoulpour told NeurologyLive.

The PD Trial Navigator

In more news, the Parkinson’s Foundation new pilot program, dubbed PD Trial Navigator, was recently launched to support recruitment for the NEULARK trial.⁵ The initiative builds on an existing infrastructure that offers free genetic testing and counseling for individuals with PD. In a recent interview with NeurologyLive^®, James Beck, PhD, chief scientific officer at the PD Foundation, further spoke about how the PD Trial Navigator operates in practice and its role in supporting enrollment into NEULARK and similar precision-medicine trials.

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REFERENCES
1. Neuron23 to Accelerate Expansion of NEULARK Phase 2 Trial with Support from The Michael J. Fox Foundation. News release. Neuron23. June 17, 2026. Accessed June 25, 2026. https://neuron23.com/neuron23-to-accelerate-expansion-of-neulark-phase-2-trial-with-support-from-the-michael-j-fox-foundation/
2. Poewe W, Seppi K, Tanner CM, et al. Parkinson disease. Nat Rev Dis Primers. 2017;3:17013. Published 2017 Mar 23. doi:10.1038/nrdp.2017.13
3. Healy DG, Falchi M, O'Sullivan SS, et al. Phenotype, genotype, and worldwide genetic penetrance of LRRK2-associated Parkinson's disease: a case-control study. Lancet Neurol. 2008;7(7):583-590. doi:10.1016/S1474-4422(08)70117-0
4. Cookson MR. The role of leucine-rich repeat kinase 2 (LRRK2) in Parkinson's disease. Nat Rev Neurosci. 2010;11(12):791-797. doi:10.1038/nrn2935
5. New Parkinson's Foundation PD Trial Navigator Program Identifies 2,000+ Potential Participants for NEULARK Clinical Trial. News release. Parkinson's Foundation. May 26, 2026. Accessed June 24, 2026. https://www.parkinson.org/about-us/news/pd-trial-navigator