Zinger Key Points
- A single 60 mg dose of ARV-102 reduced LRRK2 protein by over 50% in cerebrospinal fluid and 90% in peripheral blood mononuclear cells.
- The Phase 1 trial showed ARV-102 was well tolerated, with headache and fatigue as the most common treatment-related side effects.
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Arvinas, Inc. ARVN unveiled first-in-human data on Friday for its experimental Parkinson’s disease treatment, ARV-102.
Results from the randomized, double-blind, placebo-controlled single ascending dose (SAD) cohort of the Phase 1 healthy volunteer trial and initial results from the multiple ascending dose (MAD) cohort were shared in a presentation at the 2025 International Conference on Alzheimer’s and Parkinson’s Diseases.
The Phase 1 trial included SAD cohorts from 10 mg to 200 mg and MAD cohorts of 10 mg to 80 mg in healthy volunteers.
In the trial ARV-102, the company’s investigational PROteolysis TArgeting Chimera (PROTAC) leucine-rich repeat kinase 2 (LRRK2) degrader, demonstrated substantial reduction of LRRK2, a multifunctional protein that has been implicated in Parkinson’s disease and progressive supranuclear palsy (PSP), in cerebral spinal fluid (CSF).
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The trial also showed an encouraging safety/tolerability profile and favorable pharmacodynamic outcomes.
A single oral dose of at least 60 mg ARV-102 induced more than 50% reduction of LRRK2 protein in cerebrospinal fluid and over 90% reduction in peripheral blood mononuclear cells.
While LRRK2 is primarily known for its role in Parkinson’s, Arvinas noted that emerging evidence suggests it also plays a role in tauopathies, including progressive supranuclear palsy (PSP).
Arvinas added that early data suggest the drug was well tolerated. Data from 47 volunteers across all SAD dose levels showed the most common treatment-related issues were headaches (17.1%) and fatigue (8.6%), although fatigue was more common among placebo recipients (25%).
In the fourth quarter of 2024, Arvinas initiated dosing in the SAD cohort of the Phase 1 clinical trial with ARV-102 in patients with Parkinson’s disease.
The company expects to complete enrollment and present initial data from the ongoing SAD cohort of the Phase 1 trial in patients with Parkinson’s disease and initiate the MAD cohort of the Phase 1 clinical trial in patients with Parkinson’s disease in 2025.
Price Action: ARVN stock is down 4.93% at $6.56 at the last check on Friday.
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