A perspective on advancing oral therapies, managing clinical risk, and building long-term value in autoimmune and inflammatory disease research.
Dr. Vitt, you’ve had a remarkable journey from co-founding 4SC to now leading Immunic. How do you reflect on this evolution in your career and the scientific milestones along the way?
It’s truly been an evolution — a continuous process of learning, adapting and refining along the way. As you gain experience, you adjust your goals, your science and your business according to how the world changes around you. At 4SC, we began with a technology-driven idea, but quickly realized that the future of our industry lies in developing new medicines that directly address unmet medical needs. Technologies have a rather quick half-life; transformative medicines do not. That insight has guided both my personal and professional journey. Now, at Immunic, advancing a clinical Phase 3 product that could potentially reach patients feels like coming full circle — almost reaching the finish line of what we set out to achieve.
Immunic recently shared encouraging long-term results from the EMPhASIS Phase 2 trial. What do these findings mean for patients living with relapsing-remitting multiple sclerosis?
These results reaffirm what we have consistently observed: vidofludimus calcium shows potential to slow MS disease progression. For patients, the greatest fear is losing independence through disability progression. In the open-label extension of our Phase 2 EMPhASIS study, we saw that after 144 weeks of treatment, 92.3 percent of participants remained free of 12-week confirmed disability worsening. That is a meaningful achievement and a strong signal that the therapy could help preserve function and quality of life for people with relapsing-remitting MS.
With enrollment now complete for the ENSURE Phase 3 trials, how do you view this milestone in advancing vidofludimus calcium toward potential regulatory approval?
Completing enrollment marked a pivotal point for us. The program had already cleared an important interim analysis, and all eyes are now on the readout expected at the end of this year. It’s an exciting moment for the company — we’re not simply hoping for success; we’re preparing for it and are confident in the strength of our science.
The CALLIPER Phase 2 trial highlighted a 31 percent reduction in disability worsening for primary progressive MS patients. How transformative could this be for treatment standards?
I strongly believe it could be a game-changer for the MS field. Beyond the 31 percent reduction seen in the primary progressive subgroup, what’s equally important is the benefit observed in patients without active inflammatory lesions — a group for whom current anti-inflammatory therapies offer little to no help. Both groups represent individuals with the highest unmet medical needs. Demonstrating an effect in these populations is highly encouraging and suggests vidofludimus calcium could potentially redefine what’s possible in progressive MS.
Beyond MS, Immunic is advancing IMU-856 for celiac disease. How does this program expand your broader vision of tackling immune-mediated diseases?
Celiac disease affects millions globally, including roughly two million people in the U.S. alone, and yet there’s no approved treatment. Even with a strict gluten-free diet, many patients continue to experience symptoms and ongoing inflammation. IMU-856 could represent a completely new treatment approach: it aims to restore proper barrier function in the gut. By addressing the root cause without suppressing the immune system and without increasing infection or cancer risk, we hope to fundamentally change how this disease is managed.
The publication of the IMU-856 Phase 1/1b results in The Lancet Gastroenterology & Hepatology was a milestone. How does this recognition shape the perception of Immunic’s research approach?
It’s a validation of our commitment to true innovation. The Lancet is among the most respected peer-reviewed journals in the field, and inclusion there underscores both the robustness of our proof-of-concept data and the novelty of our mechanism targeting SIRT6 to help restore intestinal barrier function.
This milestone reinforces confidence in our broader research strategy to develop orally administered, small molecule therapies that address the root causes of chronic inflammatory and autoimmune diseases. IMU-856 exemplifies that mission — representing a potential first-in-class, oral approach designed to help the gut heal itself rather than simply manage symptoms.
Scientific innovation requires balancing risk with long-term vision. How do you approach decision-making when advancing candidates into later stages?
It’s always about balance. We aim to push innovation forward while being thoughtful about the risks — both scientific and financial. Everything starts with understanding the unmet medical need, because that’s what drives meaningful innovation. We follow the science closely rather than external pressures, ensuring that every investment aligns with strong biological rationale and potential clinical and medical value. This culture of being guided by science and data, not by sales goals, defines Immunic’s way of operating.
As a chemist by training, how does your scientific foundation influence your leadership style?
Chemistry teaches you to be unafraid of the unknown. You experiment, design and learn from what works and what doesn’t. My background in molecular design and computational modeling trained me to think holistically, seeing the full profile of a molecule and how different parts interact. That mindset carries into leadership: integrating diverse expertise, encouraging creativity and adapting to external change. Like evolution in science, leadership is also a process of continuous adaptation in which you must stay curious and flexible, while also keeping a clear strategic direction.
Serving on the advisory board of “Bayern Kapital”, how does that experience complement your leadership at Immunic?
I truly enjoy it because it exposes me to a broad spectrum of innovation that extends far beyond biotech alone. Seeing how different fields tackle challenges broadens your perspective and reinforces the value of free, creative science. It’s also energizing; you learn from other entrepreneurs who are as passionate about their fields as we are about ours. That cross-pollination of ideas helps me bring fresh thinking back to Immunic.
Looking ahead, what excites you most about Immunic’s pipeline and the company’s role in shaping next-generation therapies?
What excites me most is the opportunity to make a real and lasting impact for patients affected by serious and life-threatening diseases. Vidofludimus calcium is approaching the finish line of its Phase 3 development in relapsing MS, with a new drug application (NDA) submission anticipated for 2027 and, if approved after review, a launch soon after. Achieving that would mean bringing a new oral treatment option to people living with relapsing MS, something meaningful for patients, for our team and for science. That shared sense of purpose — knowing our work can truly change lives — is what drives all of us at Immunic.
Daniel Vitt
Ph.D., Chief Executive Officer, Immunic
Daniel Vitt, Ph.D., is the CEO of Immunic (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. Dr. Vitt previously co-founded 4SC AG, advancing it from the research stage to a clinical-stage therapeutic development company. He studied chemistry at the University of Würzburg, where he also earned his Ph.D., focusing on the molecular design of small molecule therapeutics.
