Neuron23 has dosed the first subject in the global Phase II NEULARK trial of a brain-penetrant, potent, and selective inhibitor of Leucine-rich repeat kinase 2 (LRRK2), NEU-411, for early Parkinson’s disease (PD).
This announcement was made alongside the company’s closure of $96.5m in a Series D funding round, which saw substantial contributions from new and current investors.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The double-blind, randomised, placebo-controlled trial aims to assess the safety, pharmacokinetics, efficacy, and pharmacodynamics of NEU-411, which is administered orally.
Approximately 150 subjects will be enrolled, receiving either the therapy or a placebo daily for a treatment period of 52 weeks, along with a safety follow-up two weeks post-treatment.
In an approach to symptom measurement, the trial uses a smartphone with software developed by Roche Information Solutions (RIS) to frequently assess motor and non-motor symptoms of PD, including tremor, movement, and cognition.
The primary endpoint of the study is the change from baseline in the Roche digital biomarker score against the placebo.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataSecondary outcome measures include the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).
To facilitate subject referrals and identify potential participants, Neuron23 has partnered with Sano Genetics.
Sano is providing saliva test kits under a separate protocol to detect individuals with LRRK2-driven PD, who are then referred to NEULARK trial sites for eligibility assessment and enrolment.
NEU-411 is designed to inhibit the overactive LRRK2 kinase pathway, addressing an underlying cause of the progression of the disease in people with LRRK2-driven PD.
Neuron23 CEO Nancy Stagliano said: “The Series D financing represents further endorsement of Neuron23’s industry-leading approach, which leverages state-of-the-art precision medicine and patient identification to deliver NEU-411 to people with Parkinson’s disease who are most likely to benefit from LRRK2 inhibition, increasing probability of success in the clinic and bringing the right therapy to the right patients.”
