Immunic’s MS drug shows ‘modest’ brain volume impact, stock tumbles

Title

Immunic’s Multiple Sclerosis Drug Misses Primary Brain Volume Endpoint but Lowers Disability Risk; Shares Slide

Keywords

Immunic
Vidofludimus calcium
Multiple sclerosis (MS)
Primary progressive MS (PPMS)
Progressive multiple sclerosis (PMS)
Brain volume
Thalamic atrophy
Disability progression
Phase 2 CALLIPER trial
IMU-838
Clinical trial results
Stock drop

Key Facts

Immunic’s oral drug, vidofludimus calcium (IMU-838), failed to significantly slow whole brain volume loss in patients with progressive multiple sclerosis during the Phase 2 CALLIPER trial, missing its primary endpoint2 3 4.
The drug did show a 20% reduction in thalamic brain volume loss—a more sensitive MRI marker of neurodegeneration—compared to placebo. Thalamic atrophy is strongly associated with disease progression in MS3 4 5.
Across all study participants, vidofludimus calcium reduced 24-week confirmed disability worsening by 20%, rising to 30% in the subgroup with primary progressive MS (PPMS)1 4 5.
In patients without gadolinium-enhancing lesions at baseline (typically less responsive to anti-inflammatory therapies), the drug reduced disability worsening events by 29% versus placebo5.
Additional MRI findings included a 5% improvement in overall brain volume versus placebo and a 3.19% relative benefit in T2 lesion volume at 24 months5.
The safety profile was consistent with prior studies, with no new safety issues identified5.
Following the modest brain volume results, Immunic’s stock price fell, though some analysts highlighted the drug’s competitive risk/benefit profile for disability progression as a positive2 3.
Immunic’s CEO and some industry analysts now emphasize disability progression as a more meaningful clinical endpoint than whole brain volume loss for progressive MS drug development2.
Not all detailed study data have been released; additional endpoint results are pending4.