Experimental Mayo Clinic MS Antibody Gets Patent Nod
The Mayo Clinic and corporate partner Acorda Therapeutics Inc., which has been working on a novel drug targeting an underlying cause of multiple sclerosis, was granted patent protection on their antibody known as rHIgM22, four years after the start of early-stage clinical trials.
The U.S. Patent and Trademark Office issued the patent to Mayo and New York-based Acorda (Nasdaq: ACOR) on September 5, listing among its inventors renowned Mayo multiple sclerosis researcher Dr. Moses Rodriguez.
Mayo and the pharma company have been working together for more than 10 years to explore the potential use of rHIgM22 in multiple sclerosis (MS). The effort began in earnest in early 2013 when the U.S. Food and Drug Administration approved a Phase I clinical trial enrolling people with MS to assess its safety and tolerability.
A second Phase I study is now underway, with an expected completion date of November.
RHIgM22 is a “remyelinating” antibody and is among just a handful of drug candidates seeking to attack the subcellular roots of MS, a progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord by destroying myelin—a process known as demyelination.
Myelin is a fatty layer of membranes that insulates nerves, facilitating the transmission of electrical impulses through nerve pathways that control all neurological functions. In people with MS, disruption in neurological function often leads to impairments in movement, bowel/bladder function, vision and sexual function.
The cells that make myelin, called oligodendrocytes, can initially repair myelin damage. As MS progresses, however, the ability of oligodendrocytes to repair areas of demyelination is not sufficient to prevent permanent neurological injury.
Currently, there are no therapies that repair or restore myelin in demyelinating diseases such as MS, so if myelin can be repaired, it could be breakthrough in the MS battle. Restoring electrical conduction in this way would serve to protect the exposed nerve fiber from further damage and halt the disease’s progression.
The rHIgM22 monoclonal antibody identified by the Rodriguez laboratory at Mayo was determined in preclinical studies to protect oligodendrocytes and stimulate them to repair areas of demyelination. The antibody also resulted in sustained improvements in motor activity.
Acorda announced the results of the first Phase I study in February 2015. That trial, which followed participants for up to six months after receiving a single dose of rHIgM22, found no dose-limiting toxicities at any of the five dose levels studied. Based on that data, Acorda proceeded on to a second Phase I trial, in which MS patients who have experienced MS relapses after periods of improvement were being given increasing doses of the antibody.