MJFF grant funds expansion of trial testing NEU-411 in Parkinson’s
Neuron23 will use funds to add 4 sites to global NEULARK trial
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- An MJFF grant expands the NEULARK Phase 2 trial for early Parkinson's disease.
- NEU-411, an oral LRRK2 inhibitor, aims to slow Parkinson's disease progression.
- The trial targets patients with LRRK2 genetic profiles, assessing motor and nonmotor symptoms.
A $2.5 million research grant from The Michael J. Fox Foundation (MJFF) will help expand a Phase 2 clinical study testing the experimental treatment NEU-411 in people with early Parkinson’s disease.
Neuron23 will use the funds to activate four clinical sites in Israel for the Phase 2 NEULARK trial (NCT06680830) and to screen Parkinson’s patients who may have mutations in the LRRK2 gene, one of the most common genetic causes of Parkinson’s.
The trial is enrolling up to 150 patients across 70 locations worldwide. Participants will be identified through a partnership with Sano Genetics, using at-home genetic screening, and referred to a trial site for complete eligibility evaluation.
The funding “underscores the growing momentum behind precision medicine approaches in Parkinson’s disease,” Arash Rassoulpour, PhD, Neuron23’s chief operating officer, said in a company press release. “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.”
“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,” said Shalini Padmanabhan, PhD, MJFF’s senior vice president and head of translational research.
Oral treatment aims to slow disease progression
A hallmark of Parkinson’s is the formation of toxic clumps of misfolded alpha-synuclein protein in nerve cells, which is believed to contribute to their progressive dysfunction and death.
Variations in the LRRK2 gene can increase the activity of the LRRK2 enzyme, a driver of both inherited and idiopathic (of unknown cause) Parkinson’s. Besides LRRK2 mutations, Neuron23 has identified single-nucleotide polymorphisms (SNPs, small variations within a gene) that may contribute to LRRK2 overactivity.
NEU-411 is a small-molecule inhibitor of LRRK2 activity that aims to slow disease progression. The treatment is taken orally and is designed to reach the brain, where it will exert its effects. According to the company, the treatment was well tolerated and reduced LRRK2 activity in a Phase 1 trial (NCT05755191) that enrolled healthy adults.
The NEULARK trial is testing the treatment in people with early Parkinson’s, ages 40 to 80, who have predicted elevations in LRRK2 activity based on their genetic profiles. Participants will be randomly assigned to receive NEU-411 or a placebo daily for one year.
The trial will assess the treatment’s safety and efficacy in easing Parkinson’s motor symptoms, such as slowed movement and tremor, and nonmotor symptoms such as cognitive issues, using a smartphone equipped with a digital biomarker tool developed by Roche Information Solutions to monitor disease symptoms.
The main goal is to assess NEU-411 safety and changes in the digital biomarker score relative to a placebo. Secondary outcomes include changes in the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale, a validated tool for evaluating Parkinson’s symptoms.
“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,” said Roy Alcalay, MD, chief of the Tel Aviv Sourasky Medical Center’s movement disorders division.
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