Company: ARVN
Filing Date: 2025-08-06
Form Type: 10-Q
Source: 0001655759-25-000139
Chunk: 170

Company: ARVINAS, INC.
Filing Date: 2025-08-06
Form: 10-Q
Item: Part I, Item 8
Chunk 170
---
 are associated with PSP progression. Additionally, we have published data associating the tau pathology of PSP with LRRK2 –mediated endolysosomal dysfunction. 

We are currently conducting two ongoing clinical trials with ARV-102, a Phase 1 clinical trial in healthy volunteers and a Phase 1 clinical trial in patients with PD.

We completed enrollment for the single ascending dose, or SAD, and multiple ascending dose, or MAD cohorts of the ARV-102 Phase 1 clinical trial in healthy volunteers in the first quarter of 2025 and we expect to share final data from the SAD and MAD cohorts of this clinical trial in the second half of 2025. 

We completed enrollment in the SAD cohort of the ARV-102 Phase 1 clinical trial in patients with PD in the second quarter of 2025. We expect to share initial data from this SAD cohort of the Phase 1 clinical trial in the second half of 2025. Further, in the second quarter of 2025, we received Clinical Trial Application approval in the Netherlands to initiate a multiple dose cohort of the Phase 1 clinical trial in patients with PD, and we expect to initiate enrollment in this cohort in the second half of 2025. We expect to present initial data from the multiple dose cohort in 2026. We also plan to initiate a Phase 1b clinical trial of ARV-102 in patients with PSP in the first half of 2026.

In the second quarter of 2025, we presented data from the first-in-human clinical trial of ARV-102 at the 2025 International Conference on Alzheimer’s and Parkinson’s Diseases, or AD/PD™ 2025, including results from the randomized, double-blind, placebo-controlled SAD cohort, and initial results from the MAD cohort, of the Phase 1 healthy volunteer clinical trial. 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