rHIgM22 is a remyelinating antibody being studied by Accorda Therapeutics for the treatment of multiple sclerosis (MS).

A remyelinating antibody is a human monoclonal antibody that binds to the surface of oligodendrocytes (cells that make myelin). Remyelinating antibodies contribute to the formation of new myelin (remyelination) both in vivo and in vitro, and are able to cross the blood-brain barrier and target the MS lesion. They are expressed at a specific moment of the glial cell development and bind specifically to myelin.

rHIgM22 has been cleared by the U.S. Food and Drug Administration (FDA) to enter clinical trials.

Accorda’s Phase 1 clinical trial (NCT01803867) to test the safety of the therapy in 72 participants with MS has already been completed. The male and female participants, ages 18 to 70 with MS with fixed neurological deficits, showed no side effects. The antibody crossed the blood-brain barrier in 19 participants. It also showed a long (3- to 4-day) half-life in the blood of participants.

Another Phase 1 trial (NCT02398461) is now recruiting participants who have MS in acute relapse. It aims to determine if a single dose of rHIgM22 is safe and tolerable during relapse. It is a multi-center, double-blind, randomized, placebo-controlled, dose-escalation study.



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