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Subcutaneous lecanemab for Alzheimer's disease (AD) shows low immunogenicity and comparable efficacy to intravenous dosing. This new formulation offers a convenient and safe alternative for patients, with reduced systemic reactions.

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Area of Science:

  • Neuroscience
  • Pharmacology
  • Clinical Trials

Background:

  • Lecanemab (10 mg/kg IV Q2W) demonstrated efficacy in slowing Alzheimer's disease (AD) progression in the Clarity AD trial.
  • Pharmacokinetic/pharmacodynamic (PK/PD) modeling linked lecanemab concentrations to amyloid plaque reduction and ARIA-E.
  • A subcutaneous formulation was developed to potentially improve safety and reduce systemic reactions.

Purpose of the Study:

  • To update on clinical results from the subcutaneous lecanemab development program.
  • To evaluate the safety, tolerability, and pharmacodynamic profile of subcutaneous lecanemab.
  • To compare subcutaneous lecanemab to the approved intravenous formulation.

Main Methods:

  • Phase 3 Clarity AD study involved patients with early AD randomized to placebo or lecanemab (10 mg/kg biweekly).
  • Subcutaneous dosing development utilized PK/PD modeling, bioavailability data, and a substudy within the Clarity AD open-label extension.
  • Validated anti-drug antibody (ADA) and neutralizing antibody (Nab) assays were employed.

Main Results:

  • Weekly 360 mg subcutaneous lecanemab exhibited low ADA rates (2%) and maintained plasma biomarkers consistent with AD pathology inhibition.
  • Modeling suggested comparable amyloid PET and CDR-SB effects for weekly subcutaneous maintenance dosing versus biweekly IV dosing.
  • No ARIA-E, ARIA-H, or deaths were reported with subcutaneous lecanemab; injection site reactions were infrequent and mild/moderate.

Conclusions:

  • Subcutaneous lecanemab demonstrates a low risk of immunogenicity.
  • The subcutaneous formulation offers a comparable safety, tolerability, and pharmacodynamic profile to the intravenous dose.
  • Autoinjector administration enhances patient convenience for lecanemab treatment.