New Positive Data from Relapsing-Remitting Multiple Sclerosis Clinical Trial

According to a story from PR Newswire, Immunic, Inc., a biopharmaceutical company prioritizing the development of oral immunology medicines for the treatment of chronic inflammatory and autoimmune disorders, has reported that new encouraging data is available from its phase 2 clinical trial. This trial is evaluating vidofludimus calcium as a treatment for relapsing-remitting multiple sclerosis. This open label, long-term treatment data demonstrated a reduced rate of worsening disability over time when compared to other commonly used treatments.

About Multiple Sclerosis

Multiple sclerosis is a neurological disease which is characterized by damage to the myelin sheath, a fatty, insulating, protective covering that surrounds nerve cells and allows them to communicate effectively. Although a precise cause has not been determined, multiple sclerosis is considered an autoimmune disease, in which a certain trigger, such as an infection, may cause the immune system to mistakenly attack healthy tissue. Smoking and certain genetic variants are also considered risk factors for the disease. Symptoms include blurred vision, double vision, blindness in one eye, numbness, abnormal sensations, pain, muscle weakness, muscle spasms, difficulty speaking and swallowing, mood instability, depression, loss of coordination, and fatigue. There are a number of treatments available for the disease, but no cure. Life expectancy for patients is slightly reduced. To learn more about multiple sclerosis, click here.

About The Clinical Trial

The trial began with a blinded 24-week primary treatment period comparing different doses of the treatment (10, 30, and 45 mg) versus placebo. In this period, the trial met all primary and secondary endpoints. The long-term open-label portion of the trial will run for up to 9 and a half years and is currently ongoing. 209 patients were still on treatment when the latest data analysis was performed last October.

12-week and 24-week Confirmed Disability Worsening (12w/24wCDW) was the principal endpoint used in the primary treatment period and the open-label extension. In the open-label phase, 97.6 percent of patients were free of 12wCDW at 48 weeks; this figure reached 94.5 percent at 96 weeks. Findings were similar for sustained CDW and 24wCDW. Overall, these rates were better than placebo and highly comparable with the best performing therapies that are currently approved and in use for relapsing-remitting multiple sclerosis.

These findings bode well for the future of vidofludimus calcium and for patients that are not responding to current treatments. A phase 3 trial program is also underway, and vidofludimus calcium is also being evaluated in a phase 2 trial for the progressive form of multiple sclerosis.

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