Company: ARVN
Filing Date: 2025-05-01
Form Type: 10-Q
Source: 0001655759-25-000085
Chunk: 7

Company: ARVINAS, INC.
Filing Date: 2025-05-01
Form: 10-Q
Item: Part I, Item 2
Chunk 7
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 compared to 25% (3/12) in placebo controls.

•Procedural pain associated with the lumbar puncture occurred in 28.6% (10/35) of treated individuals compared to 41.7% (5/12) in placebo controls. Post lumbar puncture syndrome was only observed in the treated cohort, at a rate of 17.1% (6/35).

•No serious adverse events were reported in either the SAD or MAD cohorts.

ARV-102 Exposure in Plasma and CSF

•ARV-102 exhibited median maximum concentration six hours after oral administration.

•The area under the concentration-time curve in the first 24 hours post dosing and the maximum plasma concentration increased in a dose-dependent manner and the median terminal plasma half-life was 73 hours.

•ARV-102 levels in CSF increased in a dose dependent manner in both the SAD and MAD cohorts.

Pharmacodynamic Evaluation

•At single doses of greater than or equal to 60 mg and repeated doses of greater than or equal to 20 mg, LRRK2 reduction of greater than 90% in peripheral blood mononuclear cells was observed.

•ARV-102 at single doses of greater than or equal to 30 mg induced greater than 50% decreases in peripheral phospho-Rab10T73, a LRRK2 substrate and biomarker for downstream LRRK2 activity; data for this endpoint in the MAD cohort is pending.

•ARV-102 at single doses of greater than or equal to 30 mg resulted in greater than 90% decrease of bis(monoacylglycerol)phosphate in urine, a biomarker of lysosomal function; data for this endpoint in the MAD cohort is pending.

•In CSF, ARV-102 induced dose-dependent LRRK2 reduction, with greater than 50% LRRK2 reduction at single doses of greater than or equal to 60 mg and repeated doses of greater than or equal to 20 mg.

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Other Programs: ARV-806 and bavdegalutamide (ARV-110)

Kirsten rat sarcoma, or KRAS, is one of the most frequently mutated human oncogenes, is commonly altered in pancreatic, colorectal, and lung cancers, among others, and is associated with poor prognosis and resistance to standards of care. G12D is the most common mutation of the KRAS protein. ARV-806, our PROT