Immunic, a biotechnology company focused on developing oral therapies for neurological and gastrointestinal diseases, has secured a key European patent for its lead investigational drug Vidofludimus Calcium. The patent, granted by the European Patent Office, protects label-relevant dosing regimens of the therapy and is expected to provide market protection across Europe until 2038.

The patent, EP3713554, broadly covers vidofludimus and its various forms—including salts, solvates and free acid versions—when used according to approved dosing regimens. This protection extends beyond a single formulation, ensuring that alternative forms of the drug would also fall under the scope of the patent if used in accordance with its label.

According to the company, the patent may also qualify for a Supplementary Protection Certificate (SPC), which could extend exclusivity for the therapy in Europe potentially until 2043. A similar patent covering the dosing regimens was previously granted by the United States Patent and Trademark Office in 2023.

The newly granted patent further strengthens Immunic’s intellectual property portfolio around vidofludimus calcium, which already includes multiple patents covering composition-of-matter, treatment indications, dosing regimens, manufacturing processes and formulation technologies. In the United States, these patents currently provide protection until 2041, with potential extensions under review.

The company is also pursuing additional patent applications covering the use of vidofludimus calcium and related forms for the treatment of neurodegenerative diseases, as well as pharmaceutical formulation and production processes. If granted, these applications could extend protection into the mid-2040s.

Vidofludimus calcium is an orally administered small-molecule drug candidate designed to treat chronic inflammatory and autoimmune diseases. The therapy is currently being evaluated in Phase III clinical trials for Multiple Sclerosis, with top-line results expected by the end of 2026.

The drug works through a dual mechanism of action. It activates the neuroprotective transcription factor nuclear receptor-related 1 (Nurr1), which may help protect nerve cells, while also selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). This combination provides anti-inflammatory, neuroprotective and antiviral effects that target the complex biological pathways involved in multiple sclerosis.

Earlier Phase II studies showed encouraging results in patients with relapsing-remitting multiple sclerosis, including significant reductions in brain lesions and improvements in disability outcomes. The therapy also demonstrated potential benefits for patients with progressive forms of the disease by reducing disability progression.

To date, vidofludimus calcium has been administered to more than 3,400 individuals across clinical studies and has demonstrated a favourable safety, tolerability and pharmacokinetic profile. However, the therapy has not yet been approved or licensed in any country.

Through continued expansion of its intellectual property portfolio and ongoing clinical development, Immunic aims to strengthen the long-term commercial potential of vidofludimus calcium as a potential treatment option for patients with multiple sclerosis.