rHIgM22 is an investigational remyelinating antibody being developed by Acorda Therapeutics in collaboration with the Mayo Foundation for Medical Education for the treatment of multiple sclerosis (MS).
How rHIgM22 works
The symptoms of MS are caused by the immune system mistakenly attacking the myelin sheath (a protective layer that surrounds nerve fibers), causing inflammation and eventual permanent nerve damage in the brain and spinal cord.
One therapeutic target for MS is the oligodendrocyte precursor cells (OPCs), a set of cells that in the correct conditions can develop into oligodendrocytes capable of repairing the damaged myelin sheath. This process is called remyelination and can help reverse the damage caused by the disease. In MS, these cells fail to develop as normal resulting in reduced, or no, remyelination.
rHIgM22 is an antibody (a protein designed to interact with a specific target) that binds to the surface of oligodendrocytes and is expected to promote remyelination in MS patients.
Preclinical trials of rHIgM22 in the mouse model of demyelination demonstrate that the drug has the potential to promote differentiation of OPCs into oligodendrocytes and accelerate remyelination in the brain. These results were published in the scientific journal Neurobiology of Disease in 2017.
rHIgM22 in clinical trials
rHIgM22 has been cleared by the U.S. Food and Drug Administration (FDA) to enter clinical trials.
Acorda’s Phase 1 clinical trial (NCT01803867), to test the safety of the therapy in 72 participants with MS over a six-month period, has already been completed. The results were presented at the 67th American Academy of Neurology Annual Meeting in 2015. During the trial, participants, ages 18 to 70 with MS with fixed neurological deficits (also called “stable disease”), were treated with a five-stage escalating dose of rHIgM22. The antibody crossed the blood-brain barrier in the 19 participants tested. It also showed a long (three to four days) half-life in the blood of participants.
The treatment was well-tolerated and no severe side effects were noted during the study. The most common side effects observed were headaches, contact dermatitis, MS relapse, swelling at the site of infusion, fatigue, pain in the joints, back, neck, arms, and legs, muscle weakness, itching, confusion, and flushing
A second Phase 1 trial (NCT02398461) finished recruiting participants with MS. 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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