EQS-News

Immunic Announces Publication of Extended Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in RRMS in the Peer Reviewed Journal, Neurology Neuroimmunology & Neuroinflammation - Seite 2

“The publication of our phase 2 EMPhASIS trial results for both study cohorts with an extended dose range in such a prestigious peer-reviewed journal represents further evidence of the strength of these findings for vidofludimus calcium in patients with RRMS,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “As reported, a dose-dependent effect of vidofludimus calcium on the suppression of new combined unique active (CUA) magnetic resonance imaging (MRI) as well as gadolinium-enhancing (Gd+) lesions was demonstrated along with an encouraging initial signal towards reducing 12-week and 24-week confirmed disability worsening events as compared to placebo during the double-blind treatment period. The findings impressively underline the drug’s combined neuroprotective and anti-inflammatory effects. Meanwhile, we continue to enroll patients in our twin phase 3 ENSURE trials in relapsing multiple sclerosis, from which we expect to report an interim futility analysis in late 2024, with the top-line readout of the first of the ENSURE trials anticipated in the second quarter of 2026.”

Vidofludimus calcium, an orally available first-in-class nuclear receptor related 1 (Nurr1) activator and next-generation dihydroorotate dehydrogenase (DHODH) inhibitor, was shown to have suppressed MRI disease activity compared to placebo in patients with RRMS in the first cohort of the multicenter, double-blind, randomized, placebo-controlled phase 2 EMPhASIS trial, achieving all primary and key secondary endpoints with high statistical significance. The results of study cohort 1, exploring the doses of 30 mg and 45 mg of vidofludimus calcium in RRMS patients versus placebo, were published in Annals of Clinical and Translational Neurology in 2022 (Fox RJ, et al. Ann Clin Transl Neurol. 2022;9(7):977-987).

Given that both doses of 30 mg and 45 mg of vidofludimus calcium showed comparable robust activity on multiple endpoints, the trial enrolled an additional cohort of patients to receive a lower dose of vidofludimus calcium in order to further investigate a dose-response relationship by extending the trial to a broader dose range. Study cohort 2 explored the dose of 10 mg of vidofludimus calcium versus placebo. Extended results from the pooled EMPhASIS data (cohorts 1 and 2, including comparison to the pooled placebo group from both study cohorts) were summarized in more detail in this latest peer-reviewed article.