Immunic (IMUX) Stock Gapped Up 17.6% on Clinical Trial Results

The Immunic Inc (NASDAQ: IMUX) stock price gapped up 17.6% after announcing positive interim data from its Phase 2 CALLIPER trial of nuclear receptor-related 1 (Nurr1) activator vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS).

The preliminary analysis indicates that vidofludimus calcium may have broader effects than initially anticipated, extending beyond its well-documented anti-inflammatory properties to underscore its potential as a neuroprotective agent.

The predefined interim assessment scrutinised alterations in serum neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) levels over 24 weeks, focusing on roughly half of the trial's participants.

Consistently positive serum neurofilament light chain (NfL) responses were noted across various subpopulations of progressive multiple sclerosis (MS) patients treated with vidofludimus calcium. 

In the broader progressive MS population, comprising 203 individuals, vidofludimus calcium exhibited a remarkable 6.7% reduction in serum NfL levels at 24 weeks, in contrast to a significant 15.8% increase observed in the placebo group (p=0.01, post hoc analysis).  

While still in its early stages, the interim data for glial fibrillar acidic protein (GFAP) also offered encouraging signs. At 24 weeks among 203 patients, GFAP levels increased by only 3.7% in the vidofludimus calcium group and 4.4% in the placebo group. 

By the 48-week mark, among 79 participants, the change in GFAP was even more promising, with a modest 2.7% increase in the vidofludimus calcium group compared to a 6.4% increase in the placebo group.

Daniel Vitt, PhD, CEO and President of Immunic, commented: “The clear separation observed in serum NfL for vidofludimus calcium over placebo in the PMS patient population represents another major step forward for, what potentially could be a first-in-class Nurr1 activator for MS. Although no head-to-head data is available, it is encouraging to see that vidofludimus calcium's improvement in NfL over placebo appears at least as good as and is, in fact, numerically higher than that observed with historical studies of other therapeutic approaches for PMS. We believe that if the top-line CALLIPER data, expected in April of 2025, continue to show a neuroprotective effect, we may be able to position vidofludimus calcium as the first oral treatment option for non-active SPMS.”

Immunic (IMUX) stock price. 

The Immunic (IMUX) stock price gapped up 17.61% to trade at $1.87, from Monday’s closing price of $1.59.