The Phase 1 trial was a single-center, randomized, double-blind, placebo-controlled study that evaluated multiple doses of ARV-102 (20 mg, 40 mg, and 80 mg) administered orally. The results were presented at the 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Copenhagen, Denmark. The data showed that ARV-102 was well tolerated, with no serious adverse events reported, and all treatment-emergent adverse events were mild in severity.
Pharmacokinetic analysis revealed that ARV-102 levels in CSF increased in a dose-dependent manner, suggesting effective brain penetration. The area under the concentration-time curve (AUC) and maximum plasma concentration (Cmax) increased with dosage, with a mean terminal plasma half-life of 68 hours. Importantly, the treatment also led to a reduction in neuroinflammatory biomarkers associated with LRRK2-related Parkinson's disease, further supporting the drug's potential therapeutic benefits.
Based on these encouraging results, Arvinas plans to continue the investigation of ARV-102 in neurodegenerative diseases linked to LRRK2 dysfunction, including progressive supranuclear palsy (PSP). The company intends to initiate a Phase 1b clinical trial in PSP in the second quarter of 2026, with the possibility of starting a registrational trial later in the year. This development marks a significant step forward in the treatment landscape for patients suffering from these debilitating conditions.
