Company: ARVN
Filing Date: 2025-10-06
Form Type: 8-K
Source: 0001628280-25-044212
Chunk: 1

Company: ARVINAS, INC.
Filing Date: 2025-10-06
Form: 8-K
Item: Item 8.01
Chunk 1
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Item 8.01 Other Events.

On October 5, 2025, the Company announced the presentation of late breaking, positive Phase 1 clinical trial data for ARV-102, a PROTAC LRRK2 degrader at at the 2025 International Congress of Parkinson’s Disease and Movement Disorders®. The Company presented data from two clinical trials: ARV-102-101, a first-in-huma n trial of ARV-102 in healthy volunteers, and ARV-102-103, a trial in patients with Parkinson’s disease. Key findings from the clinical trials include:

Data from a Phase 1 Single Ascending Dose and Multiple Ascending Dose Clinical Trial in Healthy Volunteers

• 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 cerebrospinal fluid ("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 Clinical Trial in Patients with Parkinson’s Disease and CSF Proteomic Data from a Phase 1 Trial in Healthy Volunteers

• Safety: The Phase 1 clinical trial in patients with Parkinson’s included 15 patients treated with ARV-102 and 4 patients treated with placebo. In the trial, single doses of ARV-102 (50 mg or 200 mg) were well tolerated with only mild treatment-related AEs including headache, diarrhea, and nausea; no SAEs occurred.

• Pharmacokinetics: In patients with Parkinson’s disease, ARV-102 exposure increased in a dose-dependent manner in both plasma and CSF, the latter indicating brain penetration.

• Pharmacodynamics: In patients with Parkinson’s disease, treatment with ARV-102 resulted in median PB