Vidofludimus calcium is intended for the treatment of relapsing-remitting multiple sclerosis. Credit: Shidlovsky / Shutterstock.

Immunic has unveiled data from the Phase II EMPhASIS trial evaluating vidofludimus calcium (IMU-838) in patients with relapsing-remitting multiple sclerosis (RRMS).

The placebo-controlled, randomised, parallel-group, multicentre, double-blind study assessed the safety and efficacy of the dihydroorotate dehydrogenase inhibitor IMU-838.

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It included a screening period, a blinded 24-week main treatment period, an optional initially blinded and an open-label extended treatment period of up to nine and a half years.

A total of 268 patients aged more than 18 to 55 years were enrolled in the study.

They received 30mg and 45mg orally once a day in the cohort 1 main study and in the cohort 2 sub-study, they were given 10mg once daily.

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    The study met primary and key secondary endpoints with high statistical significance, as well as a safety and tolerability profile similar to placebo.

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    Improvements in serum Neurofilament Light chain (NfL) were also observed in both treatment arms of vidofludimus calcium over placebo.

    Immunic CEO and president Daniel Vitt said: “The observation in our EMPhASIS trial that vidofludimus calcium shows a meaningful improvement in serum NfL even in a non-active MS patient population is very encouraging, as it suggests that the drug may even be active in the absence of inflammation, further supporting a potential role in neuroprotection.

    “We believe that these effects may be related to vidofludimus calcium’s potent Nurr1 activation.”

    The 24-week interim data from Immunic’s Phase II CALLIPER trial of vidofludimus calcium also showed improvements in serum NfL of progressive multiple sclerosis patients.

    The company is also engaged in developing small-molecule therapeutics for autoimmune and chronic inflammatory diseases.