IMUX News & Events

Immunic announced that the European Patent Office has granted a key European patent, EP3713554, directed to label-relevant dosing regimens of lead asset, nuclear receptor-related 1 activator, vidofludimus calcium. The patent is expected to provide protection for vidofludimus calcium in Europe into 2038, and may be eligible for a Supplementary Protection Certificate, which could extend market exclusivity potentially into 2043. This patent was previously granted by the United States Patent and Trademark Office in 2023. The claims broadly protect vidofludimus and its salt, solvate and free acid forms, in all label-relevant dosing regimens. This protection extends beyond a specific salt form, meaning that even alternative salts or forms will fall within the scope of the patent if used according to the label.

"The third quarter was marked by our strong presence at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis, during which we had the opportunity to highlight the clinical momentum of our lead asset, vidofludimus calcium, an orally available nuclear receptor-related 1 activator, and its potential to transform the oral multiple sclerosis therapy landscape," stated Daniel Vitt, CEO of Immunic. "The collective data meanwhile available from across our clinical MS trials, including the phase 2 CALLIPER and EMPhASIS trials, highlight vidofludimus calcium's unique promise to slow disability progression in both relapsing and progressive forms of the disease. Notably, new data from our positive phase 2 CALLIPER trial in progressive MS, also featured in the Best of ECTRIMS 2025 slide deck, showed statistically significant 24-week confirmed disability improvement in the overall patient population and consistent effects across both the primary progressive MS and non-active secondary progressive MS subgroups, further reinforcing the compound's neuroprotective and anti-inflammatory characteristics."