Immunic Inc (NASDAQ:IMUX, FRA:10VA) said on Tuesday the European Patent Office has granted a key patent covering dosing regimens for its experimental multiple sclerosis treatment vidofludimus calcium, extending potential market protection for the drug candidate in Europe to 2038.
The patent, EP3713554, protects label-relevant dosing regimens of vidofludimus calcium and broadly covers the compound and its salt, solvate and free acid forms when used according to the approved label, the company said. The protection could be extended potentially to 2043 if a Supplementary Protection Certificate is granted.
The patent had previously been granted in the United States by the US Patent and Trademark Office in 2023.
CEO Daniel Vitt said the European patent represents an important step in strengthening the company’s intellectual property strategy for the drug candidate. “Receiving this key patent in Europe represents a highly important advancement in our global intellectual property strategy for vidofludimus calcium and further reinforces the durability of our exclusivity position,” Vitt said in a statement.
Immunic said the claims extend beyond a specific salt form, meaning alternative salts or forms would also fall within the scope of the patent if used according to the label, creating a layer of protection that is difficult to design around.
Vidofludimus calcium, an oral small-molecule therapy being developed for chronic inflammatory and autoimmune diseases, is currently in phase 3 clinical trials for relapsing multiple sclerosis. Top-line trial data is expected by the end of 2026.
The drug works by activating the neuroprotective transcription factor nuclear receptor-related 1 (Nurr1), while also delivering anti-inflammatory and antiviral effects through selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH).
Immunic said the drug candidate is protected by multiple patents in the US, Europe and other jurisdictions covering composition of matter, treatment methods, dosing regimens, manufacturing processes and formulations.
In the US, existing patents provide protection into 2041 unless extended, the company said, while additional pending applications could extend protection further into the mid-2040s if granted.
Vidofludimus calcium has been studied in more than 3,400 individuals to date and has demonstrated a favorable pharmacokinetic, safety and tolerability profile, though it has not yet been approved for use in any country.