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Vidofludimus Calcium to Receive U.S. Patent for Treatment of Relapsing MS


Vidofludimus calcium is a potential first-in-class nuclear receptor related 1 (Nurr1) activator and a selective dihydroorotate dehydrogenase (DHODH) inhibitor.

Immunic Therapeutics, a biotechnology company headquartered in New York, announced recently that it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for the patent application named “Treatment of Multiple Sclerosis Comprising DHODH Inhibitors”.

The patent covers the use of Immunic’s currently investigational oral small molecule vidofludimus calcium (IMU-838) at daily doses of about 10 mg to 45 mg for the treatment of relapsing forms of multiple sclerosis (RMS). The U.S. patent number 17/391,442 also covers other salt and free acid forms of vidofludimus. The patent is expected to provide protection into 2041, with the possibility for extensions.

The coverage includes the 30-mg dose currently used in the ongoing phase 3 ENSURE-1 and ENSURE-2 studies as well as two other doses proven effective in treating RMS in earlier trials.

“Allowance of this patent, covering the dose strength of vidofludimus calcium for the treatment of RMS, including the 30 mg dosage used in our ongoing twin phase 3 ENSURE trials, significantly bolsters the multilayered proprietary intellectual property position we have strategically built around our lead, late-stage program for patients with multiple sclerosis," Daniel Vitt, Ph.D., chief executive officer and president of Immunic, said in a press release.

"Importantly, this patent for the dose strength in RMS patients covers all salt and free acid forms of vidofludimus calcium. We remain committed to protecting the technology around this phase 3 asset, in order to assure extended exclusivity upon potential regulatory approval from the U.S. Food and Drug Administration,” added Vitt.

Vidofludimus calcium is a potential first-in-class nuclear receptor related 1 (Nurr1) activator and a selective dihydroorotate dehydrogenase (DHODH) inhibitor being investigated for the treatment of relapsing and progressive forms of multiple sclerosis (MS) and ulcerative colitis.

The global phase 3 ENSURE trials are enrolling over 2,000 adults with relapsing-remitting MS or active secondary progressive MS. The trials’ primary objective is the time to first relapse up to 72 weeks. Secondary objectives include the volume of new lesions, time to disability progression, time to clinically relevant cognitive changes, and brain volume changes.

Interim data reports are expected in late 2024.

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