Vidofludimus calcium treatment reduces new lesions in patients with relapsing-remitting multiple sclerosis (RRMS), according to results from the phase 2 EMPhASIS clinical trial that were published in Annals of Clinical and Translational Neurology. The treatment is also well-tolerated and has a favorable safety profile, according to the trial results.

“Assessment in longer, larger trials is justified,” the authors said in a press release by Immunic Therapeutics. “The publication of the EMPhASIS trial results in a peer-reviewed journal is a testament to the importance of our phase 2 findings for vidofludimus calcium in patients with RRMS,” Daniel Vitt, PhD, chief executive officer and president, said.

EMPhASIS is a double-blind, placebo-controlled, randomized, parallel-group trial assessing the safety and efficacy of vidofludimus calcium. It enrolled patients with RRMS aged 18 to 55 years, who were treated with either 30 mg or 45 mg of vidofludimus calcium or a placebo.


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The results showed that after 24 weeks of treatment, the mean cumulative number of combined unique active lesions was 2.4 in patients treated with 45 mg of vidofludimus calcium, while that of those treated with placebo was 6.4.

The incidences of infectious, hepatic, or renal treatment-emergent adverse events and serious adverse events did not increase in patients treated with vidofludimus calcium compared to those given placebo.

Vidofludimus calcium is a novel, selective dihydroorotate dehydrogenase inhibitor that blocks the intracellular metabolism of activated immune cells. It is known that inhibiting dihydroorotate dehydrogenase suppresses brain lesions and disease activity in MS.

However, the tolerability of this approach is limited. Because vidofludimus calcium is a selective immune modulator that only acts on activated T and B cells and does not affect other immune cells, it may be safer and better tolerated than other therapies.

References

Fox RJ, Wiendl H, Wolf C, et al. A double-blind, randomized, placebo-controlled phase 2 trial evaluating the selective dihydroorotate dehydrogenase inhibitor vidofludimus calcium in relapsing-remitting multiple sclerosis. Ann Clin Transl Neurol. Published online June 14, 2022. doi:10.1002/acn3.51574

Immunic announces publication of data from its phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting multiple sclerosis in peer reviewed journal, Annals of Clinical and Translational Neurology. News release. Immunic, Inc; June 15, 2022.

MRI trial to explore the efficacy and safety of IMU-838 in relapsing remitting multiple sclerosis (EMPhASIS) (EMPhASIS). ClinicalTrials.gov. February 19, 2019. Updated February 11, 2022. Accessed June 20, 2022.