Trial Design for an International Phase 2 Study of the Efficacy, Safety and Pharmacokinetics of the Anti-LINGO-1 Monoclonal Antibody, BIIB033, in Subjects With a First Episode of Acute Optic Neuritis

Acute optic neuritis (AON) is characterized by inflammatory injury to the optic nerve and is frequently the first manifestation of MS. In humans, ~20% of the nerve fiber layer is lost after an AON episode. LINGO-1 (leucine-rich repeats and immunoglobulin domain-containing neurite outgrowth inhibitor receptor-interacting protein-1) is a component of CNS signaling complexes that suppress axonal repair/remyelination. Blocking LINGO-1 improves remyelination in animal models, thereby providing a rationale for evaluating the anti-LINGO-1 monoclonal antibody, BIIB033 in a Phase 2 study of subjects with AON (RENEW).