New Data from Phase 2 Multiple Sclerosis Treatment Study

From February 25-27, the Americas Committee for Treatment and Research in Multiple Sclerosis will run its ACRTIMS Forum 2021, according to BioSpace. At this forum, Clene Inc. will present interim data from two of its studies, REPAIR-MS and VISIONARY-MS, both of which evaluate CNM-Au8 as a treatment for multiple sclerosis (MS).

Robert Glanzman, the Chief Medical Officer of Clene, will present both trials’ data. You can find them here after they are presented at the conference.

About the REPAIR-MS Trial

This Phase 2 study was open-label and single-center, with the intent of investigating the pharmacokinetics, safety, brain metabolic effects, and pharmacodynamics of CNM-Au8 in multiple sclerosis patients.

Patients were given either 15 mg or 30 mg of CNM-Au8 for at least 12 weeks, administered orally every morning. Using MRS brain imaging scans, researchers can examine participants’ brains both before and after treatment. They hope to see target engagement from the therapy on biomarkers within the central nervous system that relate to neuronal metabolism and bioenergetics.

About the VISIONARY-MS Trial

This Phase 2 trial is randomized, double-blind, placebo-controlled, and multi-center in an effort to determine CNM-Au8’s safety and efficacy. Participants receive liquid form of the treatment and take 2 oz. every morning. Researchers will also be looking for the medication’s ability for neuro-reparative treatment in MS patients with chronic visual impairment. Endpoints include:

  • Primary endpoint
    • Improved low contrast letter acuity after 24 weeks of treatment
  • Secondary endpoint
    • Improved scores on the modified-Multiple Sclerosis Functional Composite subscales after 24 weeks of treatment

About Multiple Sclerosis

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 constantly feel the effects of the disorder. It can result in the loss of daily function.

There is no known cause for MS. It is an autoimmune disease, which occurs when the immune system attacks 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 females 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 impacted. 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, and there are FDA approved treatment options.

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