Immunic awarded European patent

Country

United States

Immunic Inc, a US-based biotech with a research arm in Germany, announced the awarding of a key patent by the European Patent Office on 10 March, strengthening its position ahead of the anticipated commercialisation of its lead product vidofludimus calcium (IMU-838) for multiple sclerosis. Vidofludimus is currently in Phase 3 with top line data expected at the end of 2026. If the data are positive, a regulatory review would follow.

The new patent is expected to provide protection for vidofludimus in Europe into 2038 and may be eligible for a supplementary protection certificate which could extend protection into 2043. This patent was also awarded to Immunic by the US Patent and Trademark Office in 2023 where protection is expected to extend into 2041. The patent claims broadly protect vidofludimus and its salt, solvate and free acid forms in all label-relevant dosing regimes. The protection extends beyond a specific salt form, meaning that even alternative salts or forms will fall within the scope of the patent if the product is 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,” said Daniel Vitt, the company’s chief executive, in a prepared statement. Vidofludimus is a small molecule drug being developed for chronic inflammatory and autoimmune diseases. The ongoing Phase 3 trial is in patients with relapsing multiple sclerosis. At Phase 2, the drug showed therapeutic activity in relapsing-remitting multiple sclerosis, progressive multiple sclerosis. and other diseases. 

The drug combines neuroprotective effects as a nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects by inhibiting the enzyme dihydroorotate dehydrogenase. A second product, IMU-856, is in development for gastrointestinal diseases. (Correction: In a story published in the February 2026 edition of MedNous, vidofludimus was incorrectly described as designed to restore intestinal barrier function. This is the mechanism of action of IMU-856.)

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