A new clinical trial will be conducted at The Center for Neurology of the Academic Specialist Center (ASC) in tandem with the Karolinska Institute. This study is meant to test the safety and efficacy of temelimab, a new drug made to treat multiple sclerosis. Dr. Fredrik Piehl, who is the professor of neurology at the Department of Clinical Neurosciences at the Karolinska Institute, will be leading this study. They hope to address the issue of progression without relapse within those who have MS, which Piehl identified as a “key unmet medical need.”
About Multiple Sclerosis (MS)
Multiple sclerosis (MS) is a neurological disorder that affects the sending of signals from the brain to the body. When one has this disorder, their immune systems attack myelin, which is the protective covering of nerve cells. In severe cases, these nerves can be damaged permanently.
There are two types of MS, relapsing/remitting or progressive. The former is characterized by long periods without symptoms followed by episodes of intense symptoms. Progressive MS does not include periods without symptoms, instead people with this type constantly feel the effects of the disorder. It can result in the loss of daily function. It is difficult to know the number of people who are affected by MS, as many often go without a diagnosis or are misdiagnosed. It is thought that 2.3 million people have this disorder worldwide, with 400,000 of those people living in the United States.
There is no known cause for MS. It is an autoimmune disease, which is when immune system is attacking parts of the body, in this case myelin. These attacks result in the slowing or blockage of neuro messages. It is suspected that there is a hereditary element, but a combination of genetics and environmental factors are most likely the cause. What is known is that this disorder can occur at any age, but is most common from the ages of 15 to 60, and women are twice as likely to have it.
Symptoms of multiple sclerosis can vary from patient to patient; all parts of the body can be affected. Muscles in the extremities and the eyes are most commonly affected. The first symptoms often appear between the ages of 20 to 40, which could be weakness, numbness, loss of coordination and balance, or problems with speech, vision, and bladder control. While there is currently no cure for MS, specific symptoms can be treated.
About the Study
The study will be conducted in Sweden at the Center for Neurology of ASC, which is the largest MS center in the country. About 2,400 people will be enrolled, and the qualification for enrollment is that people must have the progressive form of multiple sclerosis. Researchers will document the safety and tolerability of temelimab through increased doses, and the efficacy based on biomarkers associated with disease progression. This treatment for the progressive form of MS will meet a need that has long been ignored, according to Piehl, the leader of the study. He is excited to begin enrolling patients in the first quarter of 2020.
Temelimab is a monoclonal antibody that is meant to stop the production of the protein pHERV-W Env, which activates microglia in the brain, which then attack myelin. It is also meant to help the brain produce more myelin through the “inhibition of oligodendrocyte precursor cell differentiation.” This treatment has already been tested in clinical trials by GeNeuro, which showed positive results after two years. Researchers are very excited to continue with studies of this drug and hope that it will be effective for treatment of MS.
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