Acorda Therapeutics, Inc., a company focused on therapies for neurological disorders, will present new data on its Phase 1 clinical trial evaluating rHIgM22, and five-year post-marketing safety data on AMPYRA® (dalfampridine) Extended Release Tablets (10 mg) at this year’s 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The Congress is currently being held in Barcelona, Spain, October 7 to 10, 2015, and Multiple Sclerosis News Today is reporting on the event with live, on-site coverage.
MS is a chronic, progressive neurodegenerative disorder that results from an attack on the central nervous system (brain, spinal cord and optical nerves) by the body’s own immune system, causing inflammation and destroying the myelin layer (a process called demyelination) that covers and protects neurons resulting in motor function impairment (coordination, balance, speech and vision), irreversible neurological disability and paralysis.
Myelin is produced by cells called oligodendrocytes, which can initially repair the damage inflicted to the myelin layer; however, as the disease progresses, their capacity to repair demyelination is insufficient to prevent permanent neurological damage. The investigational product rHIgM22 is a recombinant human monoclonal antibody with remyelinating properties, as it protects oligodendrocytes and stimulates them to counteract the demyelination process. Studies in preclinical models have shown that rHIgM22 can improve motor activity.
Dr. Andrew Eisen, the study’s senior author and Senior Director, Translational Medicine for Acorda, will present the data on October 8 (3:45 – 5:00pm, GMT + 1h) at ECTRIMS 2015, in a poster entitled “Pharmacokinetics of a CNS-Penetrating, Putative Remyelinating Human Monoclonal Antibody, rHIgM22, in a Phase 1 Clinical Trial in Patients with Stable Multiple Sclerosis (MS)” (Poster #661).
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Acorda’s AMPYRA is the first and only drug that has been approved to improve walking in MS patients. It is a potassium channel blocker shown to improve impulse conduction in nerve fibers with a damaged myelin layer. AMPYRA has been used by more than 100,000 individuals, and its long-term safety data will be presented by Dr. Michele Jara, study author and Senior Director, Drug Safety and Risk Management for Acorda in a poster entitled “Safety Profile of Dalfampridine Extended Release in Multiple Sclerosis: 5-Year Post-Marketing Experience in the United States” (Poster #EP1461), on October 9 (3:30 – 5:00pm, GMT + 1h).
In the United States, AMPYRA is being developed and commercialized by Acorda Therapeutics, while in markets outside the U.S. it is developed and commercialized by Biogen Idec under the name FAMPYRA.
“Acorda is committed to researching novel therapies that can improve the lives of people with multiple sclerosis. The scientific data being presented at ECTRIMS feature new information about our investigational and marketed MS therapies,” said Enrique Carrazana, M.D., Chief Medical Officer of Acorda in a press release. “Our investigational compound rHIgM22 potentially represents a completely new approach to the treatment of MS. An analysis of pharmacokinetic data of rHIgM22 showed the drug is present in the cerebrospinal fluid, and thus readily available to the brain. This is one of the most promising areas of MS research.”
You can access the full ECTRIMS 2015 Congress program here.