Immunic Therapeutics‘s IMU-838, a selective immune system modulator, can safely lower the number of brain lesions in people with relapsing-remitting multiple sclerosis (RRMS), top-line Phase 2 clinical trial data suggest.
Findings show the trial met its primary goal with statistical significance — a reduction in active lesions (gadolinium positive) on imaging scans, the company reported. It is also reported to have met key secondary goals.
“We believe this data strongly supports our goal of developing IMU-838 as an easy, safe and convenient oral treatment option for patients with RRMS and other autoimmune diseases,” Andreas Muehler, MD, chief medical officer of Immunic, said in a press release.
“We are extremely encouraged by these results and intend to now focus on the development plan with the goal of eventually making IMU-838 available as a best-in-class, once-daily oral therapy for RRMS,” Muehler added.
IMU-838 (vidofludimus calcium) is a small molecule that works by blocking the activity of an enzyme called dihydroorotate dehydrogenase (DHODH). This is believed to reduce the activity of B-cells and T-cells, immune cells that drive inflammation that can damage the nervous system in multiple sclerosis.
The Phase 2 clinical trial EMPhASIS (NCT03846219) evaluated the efficacy and safety of IMU-838 in 209 adults with RRMS across Eastern Europe. All were randomized to one of two doses of IMU-838 — 30 mg or 45 mg — or to a placebo given once daily for 24 weeks.
Of these patients, 69 were given IMU-838 at 45 mg/day, 71 were randomized to IMU-838 at 30 mg/day, and 69 to a placebo. Most enrolled, 197 people, completed the 24-week study and now have the option of continuing or starting treatment in its open-label and long-term extension phase.
The trial’s primary endpoint — its main measurement of efficacy — was the number of active brain lesions visible on an MRI scan. An MRI was performed at the study’s start (a baseline measure) and at six, 12, 18, and 24 weeks later.
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