Immunic Therapeutics is a biotechnology company developing a clinical pipeline of orally administered small-molecule therapies for chronic inflammatory and autoimmune diseases. Pulse 2.0 interviewed Immunic Therapeutics CEO Dr. Daniel Vitt to learn more about the company.
Dr. Vitt’s Background
Could you tell me about your background? Dr. Vitt said:
“My career has been driven by a combination of scientific curiosity and a desire to translate research into meaningful healthcare solutions. I studied chemistry at the University of Würzburg in Germany, focusing on quantum-chemical calculations and the molecular design of small-molecule therapeutics. After receiving my Ph.D., I co-founded the biotech company 4SC AG in 1997, where I served as Chief Scientific Officer and Chief Development Officer and helped grow the company from a research-stage start-up to an advanced therapeutic development organization with multiple clinical-stage candidates.
In January 2017, I joined Immunic as co-founder and CEO, leading the company as it evolved into a Nasdaq-listed, U.S.-headquartered organization, initially with one early-stage clinical program to now a late-stage phase 3 company with multiple clinical assets in development. Alongside my role at Immunic, I also serve on the advisory board of the venture capital fund Wachstumsfond Bayern 2.”
Therapies In The Pipeline
What therapies are in Immunic’s pipeline? Dr. Vitt shared:
“Immunic is advancing a clinical pipeline of orally administered, small-molecule therapies, each uniquely designed to address unmet needs in chronic inflammatory and autoimmune diseases.
Our lead program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for relapsing multiple sclerosis (RMS) and a phase 2 clinical trial for progressive MS, having already shown therapeutic activity in phase 2 trials for relapsing-remitting MS, progressive MS, and moderate-to-severe ulcerative colitis. With its dual mode of action, we believe vidofludimus calcium has a real potential to elevate the current standard-of-care for all MS patients, including relapsing and progressive forms, by offering a unique combination of neuroprotective, anti-inflammatory and anti-viral effects as well as a favorable safety and tolerability profile and the convenience of a once-daily oral tablet.
Our second clinical-stage candidate, IMU-856, focuses on regenerating bowel epithelium and restoring intestinal barrier function, making it potentially valuable for various gastrointestinal diseases, including celiac disease, inflammatory bowel disease or Graft-versus-Host Disease. We have successfully completed a phase 1b clinical trial in celiac disease patients, where IMU-856 demonstrated positive results in four key dimensions of the disease’s pathophysiology – histology, disease symptoms, biomarkers and nutrient absorption – as well as a favorable safety and tolerability profile. Additionally, in a post hoc analysis of this trial, IMU-856 demonstrated a dose-dependent increase of endogenous GLP-1 levels and, in preclinical testing, showed a dose-dependent reduction of body weight gain and food consumption, indicating potential as an oral treatment option for weight management. We plan to bring IMU-856 into phase 2 clinical trials soon.
Finally, we are developing IMU-381, a next-generation molecule designed specifically to address the needs of gastrointestinal diseases, which is currently in preclinical testing.”
Interim Analysis Results From Phase 3 ENSURE Trials
Can you explain the significance of the interim analysis results from the phase 3 ENSURE trials and what the IDMC’s recommendation to continue the trial without changes means for the future of vidofludimus calcium as a treatment for relapsing multiple sclerosis? Dr. Vitt emphasized:
“The interim analysis for our ENSURE phase 3 trials was an important milestone for us. The Independent Data Monitoring Committee (IDMC) reviewed unblinded data and confirmed that the trials are not futile and that there is no need to increase the trials’ sample size in order to be able to reach their primary endpoints, thereby recommending both trials should continue as planned. That’s a solid affirmation that the trials are on the right track and that our initial assumptions around study design, sample size and relapse rate are holding up. This recommendation also reinforces our confidence in vidofludimus calcium’s potential to be a meaningful new treatment option for people with relapsing MS.”
Key Milestones To Watch For
With the phase 3 ENSURE program on track for completion in 2026, what key milestones should we watch for, and how do you see vidofludimus calcium shaping the future of oral therapies for relapsing multiple sclerosis? Dr. Vitt cited:
“Our focus will be on key readouts from both our ENSURE and CALLIPER studies. The next milestone is the top-line readout from our phase 2 CALLIPER trial, expected in April 2025. The study is particularly exploring the neuroprotective effects of vidofludimus calcium in patients with progressive MS, on top of its anti-inflammatory and anti-viral effects. Success in this trial could establish vidofludimus calcium as a first-in-class oral treatment option for progressive MS, a condition with a significant unmet need for effective therapies and multi-billion sales potential.
Beyond this, we aim to complete our twin phase 3 ENSURE trials as planned, in 2026, which would bring us closer to a potential regulatory submission in relapsing MS. Ultimately, vidofludimus calcium has the potential to redefine oral therapies for MS by addressing neuroprotection alongside inflammation, offering a unique, comprehensive approach.”
Epstein-Barr Virus’ Connection To MS And Post-COVID Syndrome
Can you also tell me a bit about Epstein-Barr Virus’ surprising connection to multiple sclerosis and post-COVID syndrome? Dr. Vitt noted:
“Epstein-Barr virus (EBV) is an incredibly pervasive virus that infects more than 90% of the global population, often lying dormant within the body, mainly in B cells. Recent research has linked EBV to several diseases, including MS and post-COVID syndrome. Studies suggest that EBV reactivation may play a role in MS disease progression, as individuals with prior EBV infection have a significantly higher risk of developing MS. For post-COVID, research is uncovering a connection between EBV reactivation and symptoms like fatigue, which mirrors common issues faced by MS patients.
Vidofludimus calcium is being studied for its potential to inhibit EBV reactivation, offering not only direct anti-viral effects, but also translating into anti-inflammatory and neuroprotective benefits, which could be beneficial for conditions like MS and post-COVID. We expect further insights from both our ongoing phase 3 ENSURE trials in relapsing MS as well as from the RAPID_REVIVE trial, an investigator-sponsored phase 2 study in patients with post-COVID syndrome.”
Company’s Milestones
What have been some of the company’s most significant milestones recently? Dr. Vitt highlighted:
“Immunic has hit some exciting milestones recently. As mentioned, the interim analysis for our phase 3 ENSURE trials for relapsing MS was a major highlight. An independent data monitoring committee reviewed unblinded data and recommended we continue the trials without any adjustments needed — an important validation for our work on vidofludimus calcium.
This past fall, we also shared new findings at The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference, where we presented key data that showcased vidofludimus calcium’s potential to address multiple aspects of MS, from neuroprotection to anti-inflammatory effects.
Additionally, our phase 2 CALLIPER trial in progressive MS is moving forward, with top-line data expected in April 2025. If these results confirm the neuroprotective effects we have seen so far, vidofludimus calcium could become the first oral treatment option for non-active secondary progressive MS (SPMS), meeting a huge unmet need in this space. At the end of 2023, we reported data from an interim analysis from the CALLIPER trial, which specifically looked at certain biomarkers such as neurofilament light chain (NfL), showing evidence that vidofludimus calcium’s activity extends beyond the previously observed anti-inflammatory effects, thereby further reinforcing its neuroprotective potential.
Our IMU-856 program has shown early promise in supporting gut health by restoring the intestinal barrier – and we have recently seen the beforementioned positive effects on body weight as well. We are preparing for phase 2 testing in celiac disease, while also exploring the drug’s potential to treat other disorders.
Each of these steps brings us closer to our goal of delivering effective, patient-friendly treatments for challenging autoimmune conditions.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Dr. Vitt assessed:
“Based on our models, we think vidofludimus calcium has a yearly peak sales potential of $2-6 billion in relapsing MS alone, if approved. For progressive MS, this can even be much higher given the very high unmet medical needs and only one drug approved so far for one specific sub-type.”
Differentiation From The Competition
What differentiates the company from its competition? Dr. Vitt affirmed:
“At Immunic, we are not only advancing innovative treatments but doing so in ways that prioritize patient accessibility and ease of use. Vidofludimus calcium, for instance, is an oral, small molecule therapy that combines neuroprotective, anti-inflammatory and anti-viral properties in a single, once-daily tablet. This contrasts with many MS treatments that may require more invasive administration methods. The safety and tolerability of vidofludimus calcium is another important aspect that sets Immunic apart.
Across our ongoing and completed studies, vidofludimus calcium has meanwhile been exposed to more than 1,800 human subjects and patients and thereby has shown an attractive and consistent pharmacokinetic, safety and tolerability profile. Additionally, our approach emphasizes both scientific rigor and adaptability, competing in a space traditionally dominated by larger pharmaceutical companies, which is a unique positioning for a biotech company like ours.”
Future Company Goals
What are some of the company’s future company goals? Dr. Vitt concluded:
“With our treatment options, we want to help patients with serious autoimmune conditions like MS or celiac disease by not only addressing the debilitating consequences of these diseases, but at the same time, also improving their quality of life. Therefore, our key goal right now is to bring vidofludimus calcium to the finish line and achieve regulatory approval in relapsing MS and potentially also in progressive MS. We truly hope that our drug candidate can make a difference for many MS patients in need.
More generally, we remain steadfast in our pursuit to develop orally administered, small molecule programs, each of which with unique features intended to directly address the unmet needs of patients with serious chronic inflammatory and autoimmune diseases. Beyond this, we aim to explore additional areas of research where our technology may have potential applications to meet the needs of those who may benefit from our therapeutic approach.”
