Immunic ‘on track’ with MS clinical trials testing vidofludimus calcium
Top-line data from Phase 2 CALLIPER study expected in April, per update
Immunic Therapeutics says it remains “on track” in testing its multiple sclerosis treatment candidate vidofludimus calcium in twin Phase 3 clinical trials with people who have relapsing disease — and in the Phase 2 CALLIPER study involving those with progressive forms of MS.
Indeed, in a new company update, Immunic says it’s looking forward to reporting top-line data from CALLIPER this April.
Meanwhile, the ENSURE-1 (NCT05134441) and ENSURE-2 (NCT05201638) Phase 3 trials are also progressing as planned, with ENSURE-1 expected to finish in the second quarter of next year and ENSURE-2 expected to wrap up shortly thereafter. “Both trials [are] on track to be completed in 2026,” the release stated.
According to Daniel Vitt, PhD, CEO of Immunic, “the past year was marked by substantial progress for … vidofludimus calcium,” also known as IMU-838.
Vidofludimus calcium is an oral small molecule designed to reduce MS-associated inflammation by blocking a protein called DHODH, which is important for immune cell function. Data also suggests the treatment may be able to exert neuroprotective effects by activating a protein called Nurr1.
By targeting the disease from multiple angles, Immunic believes vidofludimus calcium has promise for treating both relapsing and progressive forms of MS.
In 2024, “we continued to advance both our Phase 2 CALLIPER trial … and our twin Phase 3 ENSURE trials,” Vitt said. “Looking ahead, we eagerly anticipate reporting top-line data from the CALLIPER trial in April.”
Twin Phase 3 MS clinical trials testing therapy in over 2,000 patients
Jason Tardio, president and chief operating officer of Immunic, noted that “there continues to be a large unmet medical need for new therapeutic advancements in the treatment of MS that address both the neuroinflammatory and neurodegenerative aspects of the disease to better slow disability worsening.”
The trio of ongoing trials is testing whether vidofludimus calcium can help meet that need, and Immunic is optimistic.
“We believe our drug has the potential to become the first oral disease-modifying therapy approved to treat both relapsing and progressive MS to address the full spectrum of the disease,” Tardio said.
The identically designed ENSURE clinical trials, each involving more than 1,000 participants, are testing the investigational therapy in people with active, relapsing forms of MS — including relapsing-remitting MS and active secondary progressive MS.
ENSURE participants were randomly assigned to receive oral vidofludimus calcium, at a dose of 30 mg, or a placebo, once daily for up to 72 weeks, or nearly 1.5 years. Participants then have the option of entering an open-label extension, in which all will receive vidofludimus calcium for up to eight years.
The main goal of these trials is to evaluate whether the treatment candidate can significantly extend the time to a first MS relapse. Secondary goals include measures of brain lesions, brain tissue volume, cognition, and disability.
We believe our drug has the potential to become the first oral disease-modifying therapy approved to treat both relapsing and progressive MS to address the full spectrum of the disease.
An independent data monitoring committee conducted a futility analysis of interim data from the ENSURE trials in October. Such an analysis aims to determine whether a study should be stopped early because it’s very unlikely to achieve its goals, and whether more participants need to be enrolled. The committee concluded the trials were not futile and recommended they continued as planned.
“These favorable recommendations corroborated our initial assumptions about the design, powering and relapse rate of the trials and illustrate that they remain on track,” Vitt said. “The result makes us immensely confident and excited as we await the completion of the twin Phase 3 trials.”
Earlier trial data suggested ‘neuroprotective effects’ of vidofludimus calcium
The Phase 2 CALLIPER trial (NCT05054140) is evaluating vidofludimus calcium in 467 adults with SPMS or primary progressive MS who had no evidence of a relapse in the last two years prior to enrollment.
In this trial, participants also were randomly assigned to receive daily oral vidofludimus calcium — here at a dose of 45 mg — or a placebo. The study will span 120 weeks, or slightly longer than two years. It also will be followed by an open-label extension period in which all participants will be treated with the investigational therapy for up to eight years.
CALLIPER’s main goal is to evaluate changes in the rate of brain volume loss, a measure of neurodegeneration. Disability worsening and safety will be evaluated as secondary goals.
Interim data presented last year showed that vidofludimus calcium lowered levels of neurofilament light chain — a biomarker of nerve cell damage — after six months of treatment. That compared with increasing NfL levels over time among those given a placebo. The reductions were seen across MS types, age, and disability levels.
Vitt noted that the earlier CALLIPER findings “[hint at] potential neuroprotective effects of the drug.”
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