Immunic Therapeutics, a biotech firm focused on creating oral treatments for chronic inflammatory and autoimmune conditions, shared that it has been given a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent regarding the treatment of progressive multiple sclerosis. The patent application, titled “Treatment of multiple sclerosis comprising DHODH inhibitors,” covers various dosages of its main compound, vidofludimus calcium (IMU-838), including different salt forms and the free acid version, with daily doses ranging from 10 mg to 45 mg. This patent is specifically for treating progressive types of multiple sclerosis, such as primary and secondary progressive MS. If approved, this patent will provide protection until at least 2041 and could offer more market exclusivity through possible extensions.
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Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, called the patent approval a significant milestone for the company’s MS program. He noted that the new patent strengthens the already strong intellectual property around vidofludimus calcium. Dr. Vitt mentioned that this news comes after positive results from the company’s Phase 2 CALLIPER trial in patients with progressive MS. He stated that the drug continues to show promise in slowing disability progression, regardless of inflammation levels, and has shown meaningful reductions in brain volume loss and lesion growth. He also pointed out that these results are in line with what is needed for a future Phase 3 trial, which the company plans to discuss further with regulators.
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This patent is part of an increasing number of granted protections for vidofludimus calcium in several regions, including the U.S. and Europe. These include patents for the specific calcium salt used in clinical studies, as well as methods of treatment, dosage schedules, and the manufacturing process for a particular polymorph. Together, they help ensure the company’s commercial position through at least 2041 and possibly longer. Immunic also has other patent applications in the works, such as one for treating neurodegenerative diseases, which, if approved, could extend protection until 2044. Regulatory data protection as a new chemical entity adds another layer of exclusivity.
Vidofludimus calcium is currently being tested in late-stage clinical trials for multiple sclerosis and has shown effectiveness against both relapsing and progressive forms of the disease. Its dual mechanism of action is unique among MS treatments. It works by activating the neuroprotective transcription factor Nurr1, which offers both direct and indirect protection to nerve cells. Additionally, the compound inhibits the DHODH enzyme, which reduces inflammation and has antiviral effects. This combination is designed to tackle the various aspects of MS, including immune dysfunction and neurodegeneration.
So far, vidofludimus calcium has been studied in about 2,700 people and continues to show a good safety and pharmacokinetic profile. It has already provided encouraging outcomes in reducing brain lesions, slowing disability progression, and decreasing loss of brain volume in clinical studies. Although the compound is not yet approved or licensed in any country, Immunic remains committed to advancing it through late-stage trials in hopes of providing a much-needed treatment option for patients living with multiple sclerosis.
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