New patent covers progressive MS drug for patients in US
Decision should offer protection for vidofludimus calcium through at least 2041
Immunic Therapeutics will receive a new U.S. patent covering its experimental therapy, vidofludimus calcium, and some related molecules in people with multiple sclerosis (MS).
Titled “Treatment of multiple sclerosis comprising DHODH inhibitors,” the patent explicitly covers the use of the molecules in progressive types of MS, including primary progressive (PPMS) and secondary progressive MS (SPMS), at doses ranging from about 10 to 45 mg per day.
It’s expected to provide protection in the U.S. through at least 2041, with the possibility of further extensions, according to Immunic. Vidofludimus calcium is also in development for relapsing forms of MS, for which Immunic already holds patents.
“Allowance of this new key patent represents a significant advancement for our vidofludimus calcium program in [progressive forms of MS] and further strengthens its robust, multilayered intellectual property portfolio,” Daniel Vitt, PhD, Immunic’s CEO, said in a company press release.
Testing Immunic’s vidofludimus calcium
The new patent comes just a few months after Immunic announced top-line data from the CALLIPER Phase 2 trial (NCT05054140), which tested vidofludimus calcium against a placebo in 467 people with PPMS or SPMS.
The therapy significantly reduced the risk of 24-week confirmed disability progression, defined as an increase in Expanded Disability Status Scale (EDSS) scores sustained in a subsequent visit at least 24 weeks later, by 20%. That reduction reached 30% in people with PPMS, but nonactive SPMS patients also saw a 15% lower risk of progression with the drug.
“The patent comes at a pivotal time, closely on the heels of our positive Phase 2 CALLIPER trial data in [progressive MS]. Vidofludimus calcium continued to demonstrate neuroprotective potential by delaying time to 24-week confirmed disability worsening (24wCDW), supporting its ability to slow disease progression in multiple sclerosis patients,” Vitt said.
“Given that 24wCDW would be an acceptable regulatory endpoint of a pivotal phase 3 trial, we look forward to continuing to discuss the opportunity with healthcare authorities to determine next steps toward our goal of bringing this novel and exciting approach to patients with progressive forms of multiple sclerosis, where there continues to be a significant unmet medical need,” Vitt said.
Vidofludimus calcium is also being tested in the ongoing Phase 3 studies ENSURE-1 (NCT05134441) and ENSURE-2 (NCT05201638), which enrolled more than 2,000 adults with relapsing-remitting MS and active SPMS. The goal is to show the medication can delay the time to a first relapse compared with a placebo. Results are expected in 2026.
Vidofludimus calcium is designed to inhibit dihydroorotate dehydrogenase (DHODH), an enzyme that plays a central role in activating inflammatory immune cells that drive MS, while also exerting neuroprotective effects by activating a protein called Nurr1.
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