Presenter of 2 Presentations
Discussants
UPDATE ON LECANEMAB CLINICAL DEVELOPMENT, INCLUDING SUBCUTANEOUS FORMULATION
Abstract
Aims
This update on lecanemab (BAN2401) will review the study design, discuss the current status of the phase 3 study and the development of a new subcutaneous formulation.
Methods
Clarity AD is a multicenter, double-blind, placebo-controlled, parallel-group study of 18-month treatment duration with open-label extension (OLE) in patients with early AD with confirmed amyloid pathology. Eligible patients are randomized to placebo or 10 mg/kg biweekly (top dose identified in Phase 2 POC study 201) initiated with full therapeutic dosing. The primary endpoint is change from baseline in Clinical Dementia Rating-Sum-of-Boxes (CDR-SB) compared to placebo at 18 months. Key secondary endpoints include change from baseline at 18 months in amyloid PET standardized uptake value ratio (sub-study), AD COMposite Score (ADCOMS) and AD Assessment Scale-Cognitive Subscale 14 (ADAS-Cog14). A subcutaneous dose is under development based on PK/PD modeling and bioavailability data.
Results
A total of 1795 patients were randomized in CLARITY AD. ApoE4 carriers make up 69% of the population and 62% are mild cognitive impairment. The median age of patients was 72 years (range: 50-90 years). Clinical baseline characteristics are well balanced when comparing Clarity AD to the Phase 2 study 201. A subcutaneous dose will be introduced into the Clarity AD OLE to evaluate PK/PD of the formulation.
Conclusions
The phase 3 Clarity AD study is designed to confirm the clinical efficacy and safety of lecanemab versus placebo in patients with early AD. Development of a subcutaneous lecanemab formulation is progressing with the goal of more treatment options for patients.