Immunic Inc (NASDAQ:IMUX)’s chief medical officer Dr Andreas Muehler talked with Proactive about new data presented at the ACTRIMS Forum in San Diego, highlighting findings from the company’s phase 2 CALIPER trial in progressive multiple sclerosis (MS).
Proactive: Hello, you're watching Proactive. I'm joined by Immunic Chief Medical Officer, Dr Andreas Muehler. Andreas, very good to speak with you. You've just returned from the ACTRIMS Forum in San Diego, a conference focused on multiple sclerosis research and treatment. Immunic presented new data from the CALIPER Phase 2 trial there. Can you walk us through the key takeaways, please?
Dr Andreas Muehler: Yes, hi, and great to talk to you again. I just came back from the ACTRIMS Forum meeting in San Diego. This is a North America-based meeting with experts from both the neuroscience community and clinical neurologists. So, you really look at new MS research, as well as the clinical application of trials.
We were there with a very good team — several members of the management team and members of the medical and biomarker teams. We also had a booth in the industry exhibition and were well represented overall.
We had two posters and a poster session. Both posters were about our CALIPER trial, which is a Phase 2 trial in progressive MS that we read out in mid-2023. We presented some additional data on EBV reactivation and MRI outcomes in this trial.
One of the posters focused on MRI outcomes from the CALIPER trial and findings for acute and chronic inflammatory disease activity. Can you tell us more about that, please?
I’m happy to. MS is essentially two diseases overlaid. First, there's acute inflammatory disease, driven by peripheral immune cells entering the brain and causing lesions. These lesions — called MS lesions — are usually detected with MRI, and we categorize them as gadolinium-enhancing or T2 lesions.
In our poster, we showed that Vidofludimus calcium had a reducing effect on both gadolinium-enhancing and T2 lesions. That suggests Vidofludimus calcium impacts acute inflammation in MS.
The second component of MS is chronic inflammation inside the brain — something we don’t yet fully understand. This is referred to as chronic compartmentalized inflammation. Standard MRI measures don’t detect it well, but one marker we can use is called slowly expanding lesions (SELs). These lesions slowly grow over time, often with a rim around them.
In the CALIPER trial, we found a statistically significant reduction in SELs for the 45mg dose of Vidofludimus calcium compared to placebo. That’s encouraging, showing potential efficacy on both acute and chronic inflammation.
You also presented a second poster examining the effects of Vidofludimus calcium on EBV-specific T cell receptor repertoires. Why explore this, and what does it tell us?
About three years ago, a publication clearly showed that Epstein-Barr virus (EBV) is a necessary condition for MS. It's a chronic viral infection — most people get infected early in life, and the virus stays dormant in immune cells like B cells.
There’s growing evidence that molecular mimicry may play a role — antibodies reacting to EBV might also attack the central nervous system. This could explain MS progression. So, EBV reactivation is important to study.
Vidofludimus calcium is a broad-spectrum antiviral drug, and we had preclinical evidence it reduces EBV reactivation. In the CALIPER trial, for the first time, we showed clinical evidence of reduced EBV reactivation compared to placebo.
We used T-cell receptor repertoire analysis — you could compare it to tracking the “Top 100” immune targets. Under treatment with Vidofludimus calcium, EBV antigens dropped in ranking, indicating fewer reactivations. This is an emerging area, but these results are a strong signal.
Looking ahead to 2026, how do you see the year shaping up for Immunic?
We always say internally — 2026 is the year of Immunic. After more than a decade developing this drug, we’re now approaching the readout of our Phase 3 trials in relapsing MS.
We’ll report results from two identical Phase 3 trials at the end of 2026, each enrolling over 1,100 patients — more than 3,000 individuals across the program. It's a massive effort for any company, especially a biotech. These results will support potential regulatory submissions and, possibly, product launch.
We’re very excited to finally see the outcomes of years of work.
Quotes have been lightly edited for style and clarity