Immunic Completes Enrollment for Phase 3 Trials of Vidofludimus Calcium in Multiple Sclerosis

Immunic Completes Enrollment for Phase 3 ENSURE Trials in Multiple Sclerosis

Immunic, Inc., a prominent biotechnology company focused on developing therapies for chronic inflammatory and autoimmune diseases, has announced a significant milestone in its journey towards improving treatments for multiple sclerosis (MS). The company has successfully completed participant enrollment for both Phase 3 ENSURE trials of vidofludimus calcium (IMU-838) in patients diagnosed with relapsing multiple sclerosis (RMS). This crucial step brings the company closer to potential new therapeutic options aimed at alleviating symptoms and slowing the progression of this debilitating condition.

Overview of the ENSURE Trials

The ENSURE program includes two parallel multicenter, randomized, double-blind Phase 3 trials targeted at evaluating the efficacy, safety, and tolerability of vidofludimus calcium compared to a placebo in RMS patients. These trials, known as ENSURE-1 and ENSURE-2, sourced participants from over 100 sites across 15 countries, including major regions such as the United States, India, and various nations in the Middle East, North Africa, Latin America, and Central and Eastern Europe. The trials have enrolled a total of 2,221 patients, with 1,121 participants in ENSURE-1 and 1,100 in ENSURE-2.

The primary focus of these trials is to assess the time taken to experience the first relapse over a period of up to 72 weeks. Additionally, secondary measures will include monitoring confirmed disability worsening as indicated by the Expanded Disability Status Scale (EDSS), the volume of new T2 lesions, cognitive changes, and MRI-based metrics.

Immunic's Perspective

Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, expressed excitement about reaching this pivotal enrollment milestone, emphasizing the significance it holds for the late-stage MS program. He stated, “The on-schedule enrollment of the final patients in our phase 3 ENSURE trials of vidofludimus calcium marks another significant milestone for our late-stage MS program, bringing us meaningfully closer to a potential new treatment option for people living with RMS.” Vitt also highlighted the unique neuroprotective benefits observed thus far, which could greatly enhance the outcomes of the trials.

Insights from the CALLIPER Trial

In addition to the ENSURE trials, Immunic presented additional findings from the Phase 2 CALLIPER trial, which investigates the effects of vidofludimus calcium in patients with progressive multiple sclerosis (PMS). This trial has revealed promising data supporting the drug's neuroprotective potential. The recent analysis demonstrated a significant 24% reduction in the risk of confirmed disability worsening (24wCDW) in the overall PMS population compared to placebo. Specifically, different MS subtypes showed varying degrees of benefit, with reductions of 33% for primary progressive multiple sclerosis (PPMS) patients and 34% for active secondary progressive multiple sclerosis (aSPMS) patients.

These findings suggest that vidofludimus calcium has the potential to slow disease progression even in patients with minimal inflammation—a critical consideration, given the challenges faced by existing therapies that primarily target inflammatory components.

The Future of vidofludimus Calcium

Vidofludimus calcium is promising due to its unique dual mechanism of action, combining neuroprotective qualities with anti-inflammatory and antiviral effects, achieved through selective inhibition of the dihydroorotate dehydrogenase (DHODH) enzyme. Currently in late-stage clinical trials, this investigational drug has demonstrated beneficial effects in both RMS and PMS patients, showcasing substantial reductions in brain lesions and confirmed disability worsening metrics. Importantly, vidofludimus calcium has already undergone evaluations involving approximately 2,700 individuals, and data thus far indicate a favorable pharmacokinetic profile alongside satisfactory safety and tolerability.

Immunic remains optimistic as it anticipates top-line data from the ENSURE trials by the end of 2026, aiming for regulatory filings that may lead to the commercialization of vidofludimus calcium in RMS. The outcomes of these trials could pave the way for a transformative option in the oral MS therapy market, addressing a significant unmet need for safer, effective treatment modalities.

As Immunic moves forward with its clinical programs, the insights gleaned from both the ENSURE and CALLIPER trials will play an instrumental role in redefining treatment paradigms for individuals living with multiple sclerosis, offering hope for better management of this complex disease.