Neuron23 – a clinical-stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases – announced the closing of a $96.5 million Series D funding round led by a healthcare investor, with significant support from existing investors Westlake Village BioPartners, SoftBank Vision Fund 2, Redmile Group, Blue Owl, Kleiner Perkins, HBM Healthcare Investments, and Acorn Bioventures.
NEU-411: The company also announced that the first patient has been dosed in the global Phase 2 NEULARK clinical trial of NEU-411, a brain-penetrant, potent, and selective LRRK2 inhibitor, in individuals with early Parkinson’s disease (PD).
The global Phase 2 NEULARK clinical trial NCT06680830 is a randomized, double-blind, placebo-controlled study in people with early-stage, LRRK2-driven PD. And the study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of orally administered NEU-411. This trial will enroll approximately 150 participants who will receive NEU-411 or a placebo daily for a one-year treatment period.
The trial utilizes 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, including 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.
Sano Genetics collaboration: Neuron23 has collaborated 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 saliva test kits that can identify people with LRRK2-driven PD. Individuals identified will be referred to the nearest NEULARK clinical trial site for a complete eligibility evaluation and potential enrollment.
KEY QUOTES:
“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.”
Nancy Stagliano, Ph.D., Chief Executive Officer of Neuron23
“The dosing of the first patient in the NEULARK clinical trial marks a pivotal milestone in Parkinson’s disease research. For the first time, we are using a precision medicine approach to identify and enroll patients with LRRK2-driven disease. This trial’s design, incorporating a unique digital biomarker to frequently monitor disease progression, enables us to capture exceptionally precise, real-time data on both motor and non-motor symptoms, offering unparalleled insights into how the disease evolves. With multiple innovative elements cohesively working together in the NEULARK trial, we’re poised to take a significant step forward in the pursuit of effective treatments for Parkinson’s disease.”
Dr. Aaron Ellenbogen, a movement disorders neurologist, Medical Director at Quest Research Institute, and NEULARK study investigator
