NEU-411 / Neuron23 - LARVOL DELTA

Neuron23 to Accelerate Expansion of NEULARK Phase 2 Trial with Support from The Michael J. Fox Foundation (Businesswire) - "...$2.5 million grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to support expansion of the Company’s ongoing Phase 2 NEULARK clinical trial of NEU-411 into Israel.The funding supports activation of four clinical trial sites across Israel and patient screening efforts for people with early Parkinson’s disease (PD) who may have LRRK2-driven disease. Neuron23 recently screened the first patient in Israel for participation in the NEULARK study."

Financing • Parkinson's Disease

NEULARK: A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Neuron23 Inc. | Trial completion date: Sep 2027 ➔ Jun 2028 | Trial primary completion date: Sep 2026 ➔ Dec 2027

Companion diagnostic • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease • LRRK2

New PD Trial Navigator program flags thousands for NEULARK study (Parkinson's News Today) - "More than 2,000 potential participants have been identified for screening in a Parkinson’s clinical trial, thanks to the Parkinson’s Foundation‘s PD Trial Navigator matching program. The Phase 2 trial (NCT06680830), known as NEULARK, is evaluating Neuron23‘s experimental therapy, NEU-411, in up to 150 people with early-stage, LRRK2-driven Parkinson’s disease. Patient recruitment is currently underway across 70 sites in the U.S. and Europe."

Trial status • Parkinson's Disease

LRRK2 Pathway Inhibition By NEU-411, a Potent, Selective, CNS-Penetrant LRRK2 Inhibitor In Healthy Participants (MDS Congress 2025) - "NEU-411 achieved substantial and dose-dependent inhibition of peripheral and central LRRK2 kinase and pathways downstream of LRRK2, with evidence of CNS distribution and target inhibition. All doses were safe and well-tolerated. These studies warrant continued development of NEU-411 in people with PD."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • LRRK2

Neuron23 Announces $96.5 Million Series D Financing and First Patient Dosed in Global Phase 2 NEULARK Clinical Trial of NEU-411 for Early Parkinson’s Disease (Yahoo Finance) - "Neuron23 Inc...announced the closing of a $96.5 million Series D financing 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 (Cayman) Ltd., and Acorn Bioventures. The Company also announced the first patient has been dosed in the global Phase 2 NEULARK clinical trial of NEU-411, a brain-penetrant, potent and selective inhibitor of LRRK2, in people with early Parkinson’s disease (PD)."

Financing • Trial status • Parkinson's Disease

A PHASE 1 STUDY OF NEU -411, AN ORALLY AVAILABLE, POTENT, SELECTIVE, AND BRAIN -PENETRANT SMALL-MOLECULE INHIBITOR OF LRRK2 (ADPD 2025) - "Part A was a single ascending dose study including a food effects (FE) evaluation; Part B was a seven -day multiple ascending dose study; Part C was a 28-day dosing study testing three dose levels; Part D was a non -randomized, two -period open -label, single dose sequential design to determine if there was a drug -drug interaction (DDI) with itraconazole, a strong cytochrome P450 3A4 inhibitor; and Part E was a six -sequence, c ross-over, randomized open -label study design to evaluate the relative bioavailability and FE of NEU -411 in a capsule formulation as compared to NEU-411 in a tablet formulation. The risk-benefit and pharmacokinetic -pharmacodynamic (PK -PD) profile of NEU -411 warrant further study in patients with PD. Neuron23 is developing a proprietary companion diagnostic designed to identify patients with LRRK2 -driven PD who may be more likely t o benefit from tr eatment with NEU -411. The NEULARK Phase 2 proof -of-concept study, a placebo -controlled,..."

P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease • LRRK2

Neuron23 to Present Phase 1 Healthy Volunteer Data of NEU-411, a Brain-penetrant LRRK2 Inhibitor, at AD/PD 2025 (GlobeNewswire) - P1 | N=147 | NCT05755191 | Neuron23 Inc. | "The Phase 1 clinical trial, designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NEU-411 in 150 healthy adults and elderly volunteers, showed robust LRRK2 target and pathway engagement after NEU-411 administration. NEU-411 was well-tolerated; no serious adverse events were observed, and all adverse events were mild or moderate. The administration of NEU‑411 resulted in dramatic reductions in pS935-LRRK2 in blood and in the cerebrospinal fluid (CSF). The Company plans to present full results from the study, including modulation of phosphorylated Rab10 and di-22:6-bis(monoacylglycerol)-phosphate (BMP), at a future conference."

P1 data • Parkinson's Disease

NEULARK: A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Neuron23 Inc. | Not yet recruiting ➔ Recruiting

Companion diagnostic • Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

Neuron23 Unveils Groundbreaking Phase 2 Trial in Early Parkinson’s Disease (Businesswire) - "Neuron23 Inc...today unveiled details around its global ­­Phase 2 NEULARK clinical trial of NEU-411...The NEULARK trial represents a significant advancement in precision medicine, utilizing a state-of-the-art digital biomarker and patient stratification approach to identify individuals with LRRK2-driven PD who may be most likely to respond to treatment with NEU-411. While LRRK2 mutations are the most common cause of familial PD, representing 2% of the patient population, it is estimated that up to 30% of people with PD have LRRK2-driven disease...Our LRRK2 program is a key driver of innovation within our neuroimmunology pipeline, and we are on track to initiate this trial early in 2025."

Clinical • Trial initiation date • CNS Disorders • Parkinson's Disease

Neuron23 Announces Usage of Roche’s Digital Biomarker and Device in Parkinson’s Disease Clinical Trial (Businesswire) - "Neuron23 Inc...today announced a collaboration with Roche to incorporate a digital biomarker developed by Roche Information Solutions (RIS), the Roche group focused on digital health solutions, as the primary endpoint in the global Phase 2 NEULARK clinical trial of NEU-411, a brain-penetrant, potent and selective inhibitor of LRRK2, in early-stage Parkinson’s disease (PD)...Under the Collaboration Agreement, Roche will provide device hardware and software, site support, and digital biomarker development expertise. Neuron23 will be responsible for all aspects of clinical trial conduct. Financial terms of the agreement were not disclosed."

Commercial • CNS Disorders • Parkinson's Disease

NEULARK: A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Neuron23 Inc.

Companion diagnostic • New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

A Study to Assess NEU-411 in Healthy Participants (clinicaltrials.gov) - P1 | N=147 | Completed | Sponsor: Neuron23 Inc. | Recruiting ➔ Completed

Trial completion

A Study to Assess NEU-411 in Healthy Participants (clinicaltrials.gov) - P1 | N=147 | Recruiting | Sponsor: Neuron23 Inc. | N=64 ➔ 147 | Trial completion date: Feb 2024 ➔ Jul 2024 | Trial primary completion date: Feb 2024 ➔ May 2024

Enrollment change • Trial completion date • Trial primary completion date

A Study to Assess NEU-411 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Neuron23 Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Sep 2023 ➔ Dec 2023

Enrollment open • Trial primary completion date

A Study to Assess NEU-411 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Neuron23 Inc.

New P1 trial