NEW YORK – Immunic, Inc. (NASDAQ: NASDAQ:), a biotechnology firm focused on chronic inflammatory and autoimmune diseases, has been granted a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application regarding vidofludimus calcium (IMU-838), its lead drug candidate. The patent, which covers the composition of a specific polymorph and its production method, is part of a multilayered intellectual property strategy ensuring protection in the United States until 2041 and internationally until 2039.
The newly allowed patent is the fourth U.S. patent directed at the use of vidofludimus calcium for treating multiple sclerosis (MS). Daniel Vitt, Ph.D., CEO and President of Immunic, highlighted the significance of this advancement, stating that it strengthens the proprietary protection around their late-stage asset, which is currently in phase 3 clinical trials for relapsing MS and phase 2 for progressive MS.
Vidofludimus calcium is a small molecule investigational drug with a dual mechanism of action: it activates the neuroprotective transcription factor Nurr1 and inhibits the enzyme dihydroorotate dehydrogenase (DHODH). These properties contribute to its neuroprotective, anti-inflammatory, and anti-viral effects. The drug has been tested in over 1,800 individuals, demonstrating a favorable safety and tolerability profile.
The patent portfolio for vidofludimus calcium includes various granted patents across multiple jurisdictions. These protect the compound’s composition, specific dose strengths, and dosing regimens used in clinical trials. Additionally, pending applications could extend protection until 2044. Beyond patent exclusivity, the drug is also expected to benefit from regulatory data protection as a new chemical entity.
Immunic’s broader pipeline includes other small molecule therapies, such as IMU-856 targeting the restoration of intestinal barrier function and IMU-381 for gastrointestinal diseases. The company’s strategic approach to intellectual property aims to solidify its market position and safeguard its innovations in the field of autoimmune and inflammatory disease treatment.
This announcement is based on a press release statement from Immunic, Inc. detailing the Notice of Allowance for the patent application of vidofludimus calcium.
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