New US patent likely to cover all vidofludimus calcium doses in MS

Immunic gets positive notice on IMU-838 from Patent and Trademark Office

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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The Patent and Trademark Office intends to grant a U.S. patent covering all dosing regimens of vidofludimus calcium — being developed as IMU-838 — for the treatment of multiple sclerosis (MS).

That includes the doses being used in developer Immunic Therapeutics’ ongoing clinical program, according to a Notice of Allowance received by the company.

The U.S. patent number 17/992,162, titled “Compounds and Dosage Regimen for Use in the Prevention or Treatment of Chronic Inflammatory and/or Autoimmune Diseases,” also covers the use of other salt and free acid forms of vidofludimus calcium for MS, according to Immunic.

If issued, the patent would be valid through 2038, unless extended further — in which case the company would hold exclusive marketing rights in the U.S. for up to 14 years following a potential approval.

“This patent for dosing regimens in MS patients covers all salt and free acid forms of vidofludimus and links the expected label with respective patent claims,” Daniel Vitt, PhD, Immunic’s CEO and president, said a company press release.

“Going forward, we expect to continue to expand the layers of patent protection around vidofludimus calcium, in order to extend the exclusivity period upon its potential regulatory approval,” Vitt added.

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Multiple patents already held for vidofludimus calcium worldwide

Similar patents previously have been granted in Japan and other countries.

Immunic also recently received a notice of allowance for another U.S. patent claiming the use of vidofludimus calcium at a daily dose of about 10 to 45 mg for relapsing types of MS.

This range includes the doses proven safe and effective in earlier studies in people with relapsing MS. It also includes the 30 mg dose being tested in the ongoing ENSURE-1 (NCT05134441) and ENSURE-2 (NCT05201638) Phase 3 clinical trials. Both of these studies are expected to run through 2032.

“Coming on the heels of the recently granted dose strength patent for vidofludimus and its salts for the treatment of [relapsing MS], granting of this next fundamental patent in the United States, Japan and other countries is a critical achievement,” Vitt said.

In MS, the immune system mistakenly attacks the myelin sheath, a protective covering around nerve fibers, causing inflammation and damage to healthy parts of the brain and spinal cord. This attack is guided by a variety of immune cells, including T-cells and B-cells.

Vidofludimus calcium is a small molecule designed to reduce inflammation and protect nerve cells from damage. It does this by blocking dihydroorotate dehydrogenase, known as DHODH, an enzyme that helps T-cells and B-cells stay overactive, and while also activating the Nurr1 protein, which has neuroprotective effects.

The compound already is protected by existing patents around the world, covering various aspects, such as its composition of matter and the specific salt form and dose strengths used in clinical trials. In the U.S., these patents provide protection until 2041.

Pending applications also aim to cover a polymorph — a molecule that has the same composition as vidofludimus calcium but is arranged in a different way — as well as methods of polymorph production. Others seek to cover broader applications within the field of neurodegenerative diseases, and may extend protection until 2044.