Phase 1 clinical study of rHIgM22 initiated for treatment of multiple sclerosis

Mayo Clinic and Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the first patient has been enrolled in the first clinical trial of rHIgM22, a remyelinating antibody being studied for the treatment of multiple sclerosis (MS). This is a Phase 1 clinical trial enrolling people with MS to assess the safety and tolerability of rHIgM22. The study also includes several exploratory efficacy measures.

“Stimulation of remyelination represents a novel and potentially significant advance in the treatment of people with MS, and one which could be complementary to existing therapies. In preclinical studies, rHIgM22 has shown the ability to stimulate production of new myelin and improve function.”

In MS, a person's own immune system destroys myelin, a substance that insulates nerves and facilitates conduction of nerve impulses that control neurological function such as movement and vision. Progressive damage to myelin causes functional impairment in people with MS. Currently there are no approved therapies that stimulate the repair or regrowth of myelin once it has been damaged.

"This remyelinating antibody, if successful in clinical trials and approved, would be a novel approach to treating people with chronic neurologic deficits from multiple sclerosis or other similar conditions," said Moses Rodriguez, M.D., a neurologist specializing in MS at the Mayo Clinic, whose team initially identified rHIgM22. "We are excited that this Mayo discovery is now being evaluated in people with MS to determine its therapeutic potential."

"The current standard of MS care does not address the underlying issue of the loss of myelin that leads to progressive functional impairment in people with MS," said Anthony Caggiano, M.D., Ph.D., Acorda's Vice President of Research and Development. "Stimulation of remyelination represents a novel and potentially significant advance in the treatment of people with MS, and one which could be complementary to existing therapies. In preclinical studies, rHIgM22 has shown the ability to stimulate production of new myelin and improve function."

The primary objective of this double-blind, randomized single ascending dose study is to evaluate the safety and tolerability of rHIgM22 in people with MS. The study also includes several exploratory efficacy measures, including magnetic resonance imaging and standard clinical measures used to assess people with MS, such as walking ability. Participants in the trial will receive either placebo or rHIgM22 administered as a single intravenous dose. If rHIgM22 is well tolerated in study groups receiving a low dose of rHIgM22, subsequent groups will receive single infusions of higher doses. Participants in this study will continue receiving their standard MS treatments.