Immunic receives European patent for vidofludimus calcium dosing regimens
Immunic Inc. (NASDAQ: IMUX) announced that the European Patent Office granted patent EP3713554, which protects dosing regimens for its experimental multiple sclerosis drug vidofludimus calcium. The patent covers all forms of the compound, including salts, solvates and free acid forms.
The European patent provides protection until 2038 and may be eligible for a Supplementary Protection Certificate that could extend exclusivity to 2043. The United States Patent and Trademark Office previously granted a similar patent in 2023.
The patent claims protect vidofludimus and its various forms across all dosing regimens that would appear on the drug's label if approved. This protection extends beyond specific salt forms to include alternative salts or forms used according to the label.
"This patent creates a particularly robust layer of protection that is difficult to design around, independent of indication or formulation," stated Daniel Vitt, chief executive officer of Immunic.
Vidofludimus calcium is protected by multiple granted patents in the United States, Europe and other jurisdictions. These patents cover composition-of-matter, treatment methods for different forms of multiple sclerosis, dosing regimens, and production methods. In the United States, these patents provide protection until 2041.
The company has additional pending patent applications for treating neurodegenerative diseases that could provide protection until 2044 if granted, and pharmaceutical product applications that could extend protection until 2045.
Vidofludimus calcium is currently in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026. The oral drug combines neuroprotective effects through nuclear receptor-related 1 activation with anti-inflammatory and anti-viral effects through selective inhibition of dihydroorotate dehydrogenase.
The compound has been tested in more than 3,400 individuals and showed therapeutic activity in phase 2 trials for both relapsing-remitting and progressive multiple sclerosis.
