Immunic Inc (NASDAQ:IMUX) chief medical officer Dr Andreas Muehler joined Proactive to discuss a research update for the company's lead compound vidofludimus calcium.
Vidofludimus calcium is being supplied for an investigator-sponsored Phase 2 clinical trial focused on treating post-COVID syndrome (PCCS). The drug is also currently in Phase 3 trial for Multiple Sclerosis (MS).
Proactive: You have announced the start of an investigator-sponsored Phase 2 clinical trial for vidofludimus calcium. Can you tell us more about the trial overall?
Andreas Muehler: Yes, we are very excited about supporting this investigator-initiated trial. This trial is led by a group of German investigators who received a grant from the German government, which is interested in identifying better treatments for patients with post-COVID syndrome—what we used to call long COVID, but now refer to as PCCS.
These investigators were looking for ideas for treatments, and they approached us because we’ve been testing our lead compound, vidofludimus calcium, which is in Phase 3 clinical trials for multiple sclerosis. This drug is a broad-spectrum antiviral, and during the pandemic, we conducted a COVID trial with it. We observed that it positively influenced clinical outcomes in COVID-19 disease.
The investigators thought it could be effective in treating post-COVID syndrome, and we agreed to provide the drug because there is some overlap with our own studies in multiple sclerosis, particularly around fatigue, which plays a key role in both conditions. We have randomized the first patient in the trial, and we are hopeful that the data will provide insights into the link between virus reactivation and fatigue, which mirrors what we are seeing in multiple sclerosis.
How did the University of Frankfurt make the decision to include vidofludimus calcium in the trial, and what makes your drug the ideal choice?
We had an advantage because our coordinating investigator from the COVID-19 trial is also the principal investigator for this consortium. They approached us due to our prior work with vidofludimus calcium in treating COVID-19. We also conducted a patient survey after that trial, and even though it wasn’t a post-COVID trial, we noticed fewer patients experienced fatigue—one of the main long COVID symptoms—after receiving our drug compared to those who received a placebo.
Vidofludimus calcium is a broad-spectrum antiviral. It doesn't target a specific virus but rather inhibits the replication process that viruses rely on to spread within human cells. This makes it effective against a wide range of viruses. The fatigue seen in post-COVID patients is often linked to reactivation of sleeper viruses like Epstein-Barr virus (EBV). We think this reactivation, which happens due to immune suppression caused by COVID-19, is a significant contributor to the fatigue experienced by these patients. Our drug is well-suited for this trial because it can potentially prevent this reactivation.
You mentioned Epstein-Barr virus, and your press release indicated that the study would also gather data on EBV-related fatigue. Why is this relevant?
This is highly relevant. About two years ago, a large study involving millions of US military personnel demonstrated that Epstein-Barr virus infection is a necessary factor in developing multiple sclerosis (MS). However, not everyone with EBV develops MS, which shows that it’s a combination of the virus and an insufficient immune response that leads to the disease.
Recent data suggest that EBV reactivation may play a role in disease progression and contribute to fatigue in MS patients, more than previously thought. In our trials, we are measuring EBV reactivation in MS patients, and we hope our drug can reduce this reactivation and its associated fatigue. If we can prove this in both MS and post-COVID patients, it would position vidofludimus calcium as a differentiated treatment, particularly for managing fatigue.
So, could the RAPID_REVIVE trial have a read-through to your MS program?
Absolutely. The mechanism of EBV reactivation causing fatigue in post-COVID patients is likely the same or very similar to what we see in MS patients. This trial could provide valuable support for our MS program, which is another reason we decided to support the investigators and provide them with the study drug.
And remind us again about the next important catalyst for vidofludimus calcium in your MS development?
We expect an important catalyst in April 2025, when we anticipate results from our Phase 2 Progressive MS trial. Progressive MS is an area with very limited treatment options and a high unmet medical need. Current MS treatments for relapsing forms of the disease do not work well for progressive MS.
Our drug has neuroprotective properties, and we believe it is particularly relevant for treating progressive MS. Last October, we published interim data from the Phase 2 CALIPER trial, which showed a strong effect on blood-based biomarkers. We’re now eagerly awaiting the full readout to see if this translates to clinical outcomes like confirmed disability worsening and brain atrophy. If successful, it would be a significant advancement for treating progressive MS.
Quotes have been lightly edited for clarity and style