Company: ARVN
Filing Date: 2025-04-04
Form Type: 8-K
Source: 0001655759-25-000066
Chunk: 1

Company: ARVINAS, INC.
Filing Date: 2025-04-04
Form: 8-K
Item: Item 8.01
Chunk 1
---
Item 8.01 Other Events.

On April 4, 2025, the Company, presented data from the first-in-human clinical trial of ARV-102, the Company’s investigational PROTAC LRRK2 degrader. Results from the randomized, double-blind, placebo-controlled SAD cohort of the Phase 1 healthy volunteer trial, and initial results from the MAD cohort, were shared in a presentation at AD/PD™ 2025 in Vienna, Austria.

In the clinical trial, ARV-102 demonstrated substantial reduction of LRRK2, a multifunctional protein that has been implicated in Parkinson’s disease (“ PD”) and progressive supranuclear palsy (“ PSP”), in cerebral spinal fluid (“ CSF”), with a promising safety/tolerability profile and favorable pharmacodynamic outcomes. Key findings from the clinical trial indicated brain penetration, substantial central and peripheral LRRK2 protein degradation and signified downstream LRRK2 pathway engagement. Clinical trial design and the specific data presented at AD/PD™ 2025 are outlined below.

Clinical Trial Design

The ARV-102 Phase 1 clinical trial is designed to assess the safety, pharmacokinetics, and pharmacodynamics of orally administered ARV-102 in healthy male volunteers. This clinical trial is a single-center, randomized, double-blind, placebo-controlled trial evaluating outcomes in both SAD and MAD cohorts. In the SAD cohort, volunteers were randomized three to one, to either placebo or a single dose of ARV-102 (10 mg, 30 mg, 60 mg, 90 mg, 150 mg, or 200 mg) on day 1 with follow-up until day 10. In the MAD cohort, volunteers were randomized to either placebo or a once daily dose of ARV-102 (10 mg, 20 mg, 40 mg, or 80 mg) for 14 days with follow-up until day 28.

Safety Profile

• At the time of data cutoff (March 13, 2025), the SAD cohort of the Phase 1 clinical trial is completed and the MAD cohort is ongoing. Based on evaluation of the available data from single and multiple oral doses, ARV-102 was well tolerated in healthy volunteers.

• Of the 47 volunteers across all SAD dose levels, the primary treatment related adverse events were headache and fatigue. Headaches occurred in 17.1% (6/35) of treated individuals compared to 0% (0/12) in placebo controls.