New European patent covers all dosing regimens of experimental MS therapy
Immunic Therapeutics wins protection for vidofludimus calcium until 2038
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- A new European patent protects vidofludimus calcium, an experimental therapy for multiple sclerosis, until 2038.
- Vidofludimus calcium is in clinical trials involving people with MS, and has shown benefits.
- The patent covers all dosing regimens for the therapy candidate.
Immunic Therapeutics has been granted a new patent in Europe covering multiple dosing regimens of its experimental therapy vidofludimus calcium and related molecules for multiple sclerosis (MS) and other indications.
The patent, titled “Dosage Regimen of Vidofludimus for Use in the Treatment of a Chronic Inflammatory and/or Autoimmune Diseases,” covers all relevant dosing regimens of vidofludimus calcium, including those now being tested in MS clinical trials.
According to the company, the patent is expected to provide protection for vidofludimus calcium in Europe through 2038, with the possibility of extending coverage to 2043. A similar patent was granted in the U.S. in 2023.
“This patent creates a particularly robust layer of protection that is difficult to design around, independent of indication or formulation,” Daniel Vitt, PhD, Immunic’s CEO, said in a company press release announcing its issuance.
“Together with our existing composition-of-matter, indication, method-of-treatment, dosing, process of production and formulation patents, this European patent significantly strengthens the multi-layered protection we have built around vidofludimus calcium,” Vitt added.
MS is caused by the immune system mistakenly attacking the brain and spinal cord. In relapsing forms of the disease, inflammation driven by B-cells and T-cells is thought to play a central role. Progressive forms are believed to involve more chronic inflammation and nerve cell damage associated with immune cells that reside in the brain.
Evidence also suggests the therapy may help prevent reactivation of the Epstein-Barr virus, which has been linked to MS and may contribute to disease progression.
Vidofludimus calcium now being tested in several clinical trials
Several clinical trials are evaluating vidofludimus calcium in people with MS.
In the Phase 2 EMPhASIS trial (NCT03846219), which enrolled 268 adults with relapsing-remitting MS, treatment significantly reduced the number of lesions compared with a placebo. Participants also had fewer relapses and about half as many confirmed disability progression events.
Long-term data from EMPhASIS and its open-label extension showed that more than 90% of patients remained free of confirmed disability progression after up to 5.5 years of treatment.
Based on these findings, vidofludimus calcium is now being tested in two Phase 3 clinical trials — ENSURE-1 (NCT05134441) and ENSURE-2 (NCT05201638) — in people with relapsing forms of MS. Together, the studies have enrolled more than 2,200 participants and are evaluating whether a 30 mg dose of vidofludimus calcium can delay the time to a first relapse compared with a placebo.
Top-line results are expected by the end of the year and, if positive, could support a regulatory approval.
Vidofludimus calcium is also being evaluated in progressive forms of MS. In the Phase 2 CALLIPER trial (NCT05054140), which involved people with primary progressive MS or secondary progressive MS, the treatment did not meet its main goal of slowing brain tissue loss.
However, it reduced the risk of confirmed disability worsening by 23.8%, with benefits seen even in patients without signs of active inflammation. Treatment also associated with reductions in certain brain lesions.
Phase 3 program in primary progressive MS expected later this year
Based on these findings, Immunic plans to launch a Phase 3 program in primary progressive MS later this year, which is expected to take about 3.5 years to complete.
According to Vitt, the new European patent “reinforces the durability” of the company’s “exclusivity position” and furthers Immunic’s goal “of maximizing long-term exclusivity following potential regulatory approval” of the drug.
“Receiving this key patent in Europe represents a highly important advancement in our global intellectual property strategy for vidofludimus calcium,” Vitt said.
