Immunic Secures Fifth US Patent for Multiple Sclerosis Drug Vidofludimus Calcium, Extending Protection Through 2041
核心洞察
Immunic received a Notice of Allowance from the USPTO for its fifth US patent covering vidofludimus calcium dose strengths of 10-45 mg daily for progressive multiple sclerosis treatment.
The patent provides protection until 2041 with potential for extension, strengthening the company's comprehensive intellectual property portfolio for both primary and secondary progressive MS.
The patent approval follows positive phase 2 CALLIPER trial data showing vidofludimus calcium delayed confirmed disability worsening and reduced brain volume loss in progressive MS patients.
Immunic Inc. has received a Notice of Allowance from the United States Patent and Trademark Office for patent application 18/529,946, entitled "Treatment of multiple sclerosis comprising DHODH (搜索) inhibitors." This marks the company's fifth US patent directed toward the use of vidofludimus calcium (IMU-838) in multiple sclerosis, providing comprehensive intellectual property protection through 2041.
The patent specifically covers dose strengths of vidofludimus calcium and other salt forms, as well as free acid forms, at daily doses of approximately 10 mg to 45 mg for treating progressive multiple sclerosis (PMS). This includes both primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) patient populations.
Patent Portfolio Strengthens Market Position
"Allowance of this new key patent represents a significant advancement for our vidofludimus calcium program in PMS and further strengthens its robust, multi-layered intellectual property portfolio," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic.
The patent approval comes at a strategically important time, following positive results from the company's phase 2 CALLIPER trial in progressive MS. In that study, vidofludimus calcium demonstrated neuroprotective potential by delaying time to 24-week confirmed disability worsening (24wCDW), supporting its ability to slow disease progression in multiple sclerosis patients with or without focal inflammation.
Comprehensive IP Strategy Extends Protection
Vidofludimus calcium is now protected by multiple layers of granted patents across the United States, Europe, and other international jurisdictions. These patents cover various aspects including composition-of-matter for salt forms of vidofludimus, treatment protocols for both relapsing and progressive multiple sclerosis at specific dose strengths used in clinical trials, dosing regimens, and composition-of-matter for a specific polymorph of vidofludimus calcium along with related production methods.
In the United States, these patents collectively provide protection into 2041 or potentially beyond. Additionally, a pending application directed toward using vidofludimus calcium for treating neurodegenerative diseases could extend protection to 2044 if granted. The company has indicated that further undisclosed patent applications are currently in process to strengthen the exclusivity period.
Dual Mechanism of Action Shows Promise
Vidofludimus calcium represents a first-in-class approach with a dual mode of action that combines neuroprotective, anti-inflammatory, and anti-viral effects to target the complex pathophysiology of multiple sclerosis. As a selective immune modulator, it activates the neuroprotective transcription factor nuclear receptor-related 1 (搜索) (Nurr1 (搜索)), providing direct and indirect neuroprotective effects. The compound also achieves anti-inflammatory and anti-viral effects through highly selective inhibition of the enzyme dihydroorotate dehydrogenase (搜索) (DHODH (搜索)).
The CALLIPER trial results reinforced reductions in the annualized rate of thalamic brain volume loss and volume of new/enlarging T2 lesions. Given that 24-week confirmed disability worsening would be an acceptable regulatory endpoint for a pivotal phase 3 trial, these findings support the drug's potential for regulatory advancement.
Clinical Development Progress
Vidofludimus calcium is currently being evaluated in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026. The compound has been exposed to approximately 2,700 individuals to date and has demonstrated an attractive pharmacokinetic, safety, and tolerability profile.
In previous phase 2 clinical trials, vidofludimus calcium showed therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in reducing confirmed disability worsening. The drug has also demonstrated clinical benefits in progressive MS patients through substantial reductions in confirmed disability worsening and thalamic brain volume loss.
Regulatory Data Protection
Beyond patent exclusivity, vidofludimus calcium, classified as a new chemical entity, is expected to benefit from regulatory data protection in the United States and other jurisdictions, providing additional market exclusivity layers.
"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," Dr. Vitt concluded.
Vidofludimus calcium is not yet licensed or approved in any country, with the company continuing to advance its comprehensive development program across multiple forms of multiple sclerosis.