Arvinas Presents Late Breaking, Positive Phase 1 Clinical Data for ARV-102, a PROTAC LRRK2 Degrader, at the 2025 International Congress of Parkinson’s Disease and Movement Disorders

– ARV-102 was well tolerated in clinical trials for both healthy volunteers and patients with Parkinson’s disease –

– ARV-102 demonstrated dose-dependent cerebrospinal fluid (CSF) exposure in subjects in both trials –

– After 14 days of treatment in healthy volunteers, ARV-102 decreased lysosomal and neuroinflammatory microglial pathway biomarkers known to be elevated in Parkinson’s disease –

NEW HAVEN, Conn., Oct. 05, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced positive pharmacokinetic, pharmacodynamic, and biomarker data from two Phase 1 clinical trials evaluating ARV-102, an oral, brain-penetrant investigational PROTAC degrader of leucine-rich repeat kinase 2 (LRRK2). Results were presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS 2025) in Honolulu.

“We are particularly excited by the CSF proteomics results, which demonstrate modulation of lysosomal and microglial pathways that are known to be associated with neurodegenerative diseases,” said Noah Berkowitz, M.D., Ph.D., Chief Medical Officer of Arvinas. “We believe these findings support the intensified development of ARV-102 in ongoing studies of patients with Parkinson’s disease, and in future studies of patients with progressive supranuclear palsy.”

The company presented data from two trials: ARV-102-101, a first-in-human trial of ARV-102 in healthy volunteers, and ARV-102-103, a trial in patients with Parkinson’s disease. Key findings include:

Data from a Phase 1 Single Ascending Dose and Multiple Ascending Dose Trial in Healthy Volunteers (Poster 904):

• Safety: ARV-102 was generally well tolerated at single doses up to 200 mg and multiple daily doses up to 80 mg, with no discontinuations due to adverse events (AEs) or serious adverse events (SAEs) observed in the study population.
• Pharmacokinetics: ARV-102 exposure increased in a dose-dependent manner in plasma and CSF, the latter indicating brain penetration.
• Pharmacodynamics: Repeated daily doses ≥20 mg resulted in >90% reductions of LRRK2 protein in peripheral blood mononuclear cells (PBMCs) and >50% reductions in CSF.
• Pathway Biomarkers: Repeated daily doses of ARV-102 resulted in reduced plasma concentrations of phospho-Rab10T73 and urine concentrations of bis(monoacylglycerol)phosphate (BMP), a sensitive biomarker for modulation of the lysosomal pathway downstream of LRRK2.

Interim Single Ascending Dose Data from a Phase 1 Trial in Patients with Parkinson’s Disease and CSF Proteomic Data from a Phase 1 Trial in Healthy Volunteers (Late Breaking Abstract #22):