Immunic (NASDAQ:IMUX) executives outlined what they described as a “transformative” 2026, with pivotal data expected late in the year for the company’s lead multiple sclerosis (MS) candidate, vidofludimus calcium, and parallel work underway toward a planned new drug application (NDA) submission the following year.
Speaking in a moderated discussion, company representatives said Immunic recently raised capital and is preparing for end-of-year readouts from two Phase 3 studies in relapsing MS (RMS), ENSURE-1 and ENSURE-2. The team also said it is already preparing for an NDA submission planned for next year.
Vidofludimus calcium: “Best of two worlds” positioning
During development, Immunic said it identified a second mechanism: activation of the nuclear receptor Nurr1. The company characterized the combination—selective DHODH inhibition plus Nurr1 activation—as providing both anti-inflammatory activity and a “direct neuroprotective” effect.
Safety discussion: liver signals, embryo-fetal risk, and half-life
Management emphasized what it views as a differentiated safety and tolerability profile. In discussing teriflunomide, the team attributed several adverse effects—including hair loss, neutropenia, and lymphopenia—to kinase inhibition and said vidofludimus calcium does not share that off-target activity.
On hepatotoxicity, Immunic said the liver enzyme elevations it has seen to date with vidofludimus calcium have been comparable to placebo, including measures such as 3x, 5x, and 10x increases in ALT or AST. The company said it plans to share these data with regulators.
On embryo-fetal toxicity, management said it has generated animal data and is continuing additional studies that “may provide a differentiated profile.” The team also highlighted pharmacokinetic differences it believes could matter in labeling discussions, contrasting teriflunomide’s long elimination profile with vidofludimus calcium’s shorter half-life:
- Teriflunomide: elimination half-life described as 10–19 days; approximately three months to reach steady state; drug can remain in blood for up to two years in some patients.
- Vidofludimus calcium: elimination half-life described as approximately 30 hours; steady state in five to eight days; typically clears within 10 days.
Executives said they believe these differences could support an argument that some safety warnings applied to teriflunomide may not be required, while repeatedly noting that “the data will speak.”
Nurr1 activation and evidence cited from prior studies
Immunic said it first observed “hints of neuroprotection” in its Phase 2 EMPhASIS study in relapsing MS, including a reported 57% lower rate of confirmed disability progression versus control and a dose-dependent reduction in neurofilament light chain (NfL). The company said those findings, along with open-label extension data, prompted work with academic groups that identified vidofludimus calcium as a potent activator of Nurr1, which it said drove up to a five-fold increase in target gene expression.
The team also discussed Nurr1’s potential relevance to MS biology, citing gene expression analyses and observations that Nurr1 is upregulated during pregnancy in women with MS, a period when disease activity and progression are known to decrease.
Looking to upcoming RMS Phase 3 results, Immunic said it expects Nurr1 activation to contribute to effects on disability progression, including progression independent of relapse activity (PIRA). Management noted subgroup analyses related to PIRA may be informative but not statistically powered due to smaller patient numbers.
ENSURE Phase 3 endpoints and commercial framing
Immunic said the ENSURE studies use time to first relapse analyzed by Kaplan-Meier as the primary endpoint, describing it as a modern alternative to annualized relapse rate (ARR) while measuring similar clinical outcomes. ARR will be reported as a secondary endpoint, alongside MRI endpoints and disability-related measures including confirmed disability progression and confirmed disability improvement.
When asked about numerical thresholds for commercial competitiveness, management declined to provide guidance, emphasizing instead what it called the “totality of data,” including the balance across relapse control, safety, and disability outcomes. Executives said statistical significance on relapse-related endpoints is important for regulatory approval, while they suggested incremental benefits on disability slowing could be more meaningful for differentiation.
On positioning, Immunic said it expects to compete primarily in the oral disease-modifying therapy segment. The company cited its estimate that roughly 35%–40% of U.S. MS prescriptions are still for oral therapies. It argued that currently approved therapies involve safety trade-offs, mentioning risks such as serious infections (including progressive multifocal leukoencephalopathy), malignancy risk, and drug-induced liver injury. Immunic said it aims to offer a “best-in-oral-class benefit risk profile,” combining efficacy across relapses, disability, and MRI with improved tolerability.
The team also discussed the CD20 class of therapies, describing them as highly effective on inflammatory activity but stating that more than 30% of patients continue to progress. Management framed vidofludimus calcium’s potential impact on neurodegeneration/PIRA as a differentiator. In addition, Immunic described a potential niche for patients who must discontinue CD20 therapies due to serious infections, noting that B-cell repletion can take over two years and that it sees a need for a safe, effective sequencing option. The company characterized vidofludimus calcium as an immunomodulator rather than an immunosuppressant in that context.
Progressive MS plans and CALLIPER results cited
In progressive MS, management reviewed results from its exploratory Phase 2 CALLIPER study, which enrolled a mixed population that included non-active secondary progressive MS (about 60%), primary progressive MS (about 30%), and a smaller active SPMS cohort. Immunic said the trial showed a 24% reduction in time to 24-week confirmed disability progression in the overall cohort and a 31% reduction in the PPMS subset.
The company also said it observed statistically significant separation from placebo on change-from-baseline beginning at week 60 through 120 weeks, and it reported nearly a 2.5x increase in potential confirmed disability improvement versus placebo. Immunic said it plans to initiate a confirmatory Phase 3 study initially in PPMS in the second half of the year. It estimated the study could take roughly 3.5 to 4 years to enroll and read out, followed by about a year for submission and approval.
Closing the discussion, Immunic executives reiterated their view that unmet need remains in both relapsing and progressive MS and said they believe vidofludimus calcium’s mechanisms and safety profile could support meaningful adoption if Phase 3 RMS data are positive.
About Immunic (NASDAQ:IMUX)
Immunic, Inc is a clinical-stage biopharmaceutical company focused on developing novel oral therapies to treat chronic inflammatory and autoimmune diseases as well as certain cancers. The company’s research strategy centers on small-molecule immunology, aiming to offer targeted treatments with improved safety and tolerability profiles. By modulating key signaling pathways within the immune system, Immunic seeks to address underlying disease mechanisms and achieve durable therapeutic benefits for patients.
Immunic’s lead product candidate, vidofludimus calcium (IMU-838), is an oral selective dihydroorotate dehydrogenase (DHODH) inhibitor in Phase 2 clinical development for conditions including ulcerative colitis, Crohn’s disease and relapsing multiple sclerosis.
