Biogen and Eisai Initiate Phase 1 Clinical Trial of Subcutaneous Aducanumab Formulation

Source: PharmaCube Info

Author: Shi Bei

Biogen/Eisai recently registered a Phase I clinical trial for a subcutaneous formulation of aducanumab on the U.S. Clinical Trials Registry.

According to publicly available information, this trial is a randomized, open-label, parallel-group study. The primary objective is to evaluate the absolute bioavailability of a single subcutaneous injection of a fixed dose of aducanumab (BIIB037) compared with a single weight-based intravenous (IV) infusion of aducanumab in healthy volunteers. The secondary objectives are to assess the safety and tolerability of subcutaneous aducanumab in healthy volunteers, and to characterize additional pharmacokinetic (PK) parameters following a single subcutaneous injection of a fixed dose of aducanumab and a weight-based intravenous (IV) infusion of aducanumab in healthy volunteers.

On June 7, the FDA approved aducanumab for marketing over the objections of its advisory committee. As required by the FDA, Biogen must conduct a new randomized controlled trial to verify the clinical benefit of the drug. If the trial fails to confirm the drug's clinical benefit, the FDA may initiate proceedings to withdraw its approval.