Immunic CEO: “We want to understand MS patients better than anyone”

European Biotechnology: Mr. Lundgren, this year marks Immunic’s 10th anniversary, coinciding with what could be a decisive period in the company’s history. How would you describe Immunic’s position today?

Erik Lundgren: This is a particularly exciting time for Immunic. As we celebrate our 10th anniversary this year, we are entering what could be one of the most transformative phases in the company’s history. Over the past decade, we have built a differentiated pipeline focused on chronic inflammatory and autoimmune diseases, particularly on neurologic diseases such as MS, and generated data that reinforces our confidence in our scientific approach. Today, we are not only advancing our late-stage clinical asset vidofludimus calcium in MS, but are also preparing to become a fully integrated commercial organization. In addition to research and clinical development, we have started thinking beyond and positioning the company for long-term success. Importantly, we have assembled a highly talented and experienced team and believe that our focused strategy, combined with disciplined execution, puts us in a strong position for the months and years ahead.

EB: You came to Immunic at a pivotal time in its development. What persuaded you to join the company?

Lundgren: I have spent much of my career in MS, so I have always been fascinated by the science behind the disease. Over the years, we have seen our understanding of MS evolve significantly. First, T cells were the primary focus, then B cells and their antibody repertoire became central to how we think about the disease. I was fortunate to be part of some of those shifts at companies like Genentech and Roche, which initially were not regarded as major players in MS but ultimately helped reshape the treatment landscape.

What attracted me to Immunic is its unique scientific approach and the opportunity to address one of the field’s most significant unmet needs: the progression of disability and the neurodegenerative component of MS. When I joined the company, I saw, and continue to see, tremendous potential in the science, the lead program, and the highly talented team striving to bring this vision forward.

A truly outstanding factor is the global, multinational team. At Immunic, we have more than 20 different nationalities among roughly 100 people. That is remarkable for a company of this size and supporting our growth phase.

EB: From your years of experience in the MS field, what differentiates Immunic’s approach from previous waves of innovation?

Lundgren: Having witnessed several waves of innovation in MS throughout my career, what excites me about Immunic is that we are focused on some of the most important unresolved challenges in the disease: progression, safety and tolerability, and patient choice.

One of the reasons I joined Immunic was the insight I gained through many conversations with MS physicians and experts. While tremendous progress has been made in treating MS, significant unmet needs remain, creating opportunities for the next generation of therapies.

The first relates to disease progression. For many years, reducing relapses and controlling inflammation were the primary goals of treatment. Today’s reality is different. Many patients experience few or no relapses, yet they continue to accumulate disability over time. This progression independent of relapse activity, or PIRA, remains one of the most important challenges in MS.

The second unmet need is long-term safety and tolerability. Currently approved therapies have transformed MS patient care, but prolonged treatment can be associated with serious side effects such as infections, gastrointestinal or cardiovascular risks. As a result, therapies with favorable, well-tolerated safety profiles continue to be highly relevant.

The third unmet need is patient choice. In the U.S. alone, approximately 125,000 people diagnosed with relapsing MS remain untreated, while around 45,000 patients switch therapies each year. The reasons vary, ranging from access and reimbursement challenges to concerns about tolerability, adherence and the suitability of available treatment options at different stages of the disease. These numbers underscore that many patients and physicians continue to look for therapies that better meet their individual needs.

We believe vidofludimus calcium has the potential to address these challenges in a differentiated way, which is what makes the program so exciting.

EB: How does vidofludimus calcium address the unmet needs you have identified in MS?

Lundgren: What makes vidofludimus calcium particularly interesting is its dual mechanism of action. In preclinical studies, the molecule has demonstrated activation of the transcription factor Nurr1, which is believed to play an important role in maintaining neuronal health. At the same time, vidofludimus calcium is a selective DHODH inhibitor, modulating the activity of overactive immune cells involved in the MS disease process. This combination is especially relevant as it has the potential to target both the neurodegenerative and inflammatory drivers of the disease.

We believe this dual approach has the potential to address some of the key unmet needs in MS today: controlling inflammatory disease activity, maintaining a favorable safety and tolerability profile and potentially influencing the mechanisms underlying disability progression.

Today, vidofludimus calcium is being evaluated in Phase 3 trials in relapsing MS, which are expected to read out by the end of this year. We also plan to initiate a Phase 3 trial in progressive MS. That setting may ultimately be particularly important, as it could provide a broader dataset on the drug’s impact on neurodegenerative processes.

EB: Ultimately, these hypotheses need to be confirmed in the clinic. What are the key questions the ENSURE Phase 3 trials are designed to answer?

Lundgren: The trials are designed to provide a comprehensive assessment of relapse activity. The primary objective of the ENSURE program is to demonstrate that vidofludimus calcium can significantly reduce the risk of relapses in patients with relapsing MS, as measured by time to first relapse.

Key secondary endpoints include MRI measures such as new or enlarging T2 lesions and gadolinium-enhancing T1 lesions, as well as annualized relapse rate. Together, these endpoints give us a detailed picture of how effectively the treatment can control inflammatory disease activity.

The program also evaluates confirmed disability improvement and confirmed disability worsening in pooled analyses as part of the secondary and exploratory endpoints. While the studies are not specifically designed to measure disability and therefore the relevant signals may be limited, these endpoints can provide additional insights into the treatment’s potential impact on long-term patient outcomes.

Taken together, the ENSURE trials are designed to assess whether vidofludimus calcium can deliver meaningful clinical benefit across multiple dimensions of MS disease activity, with the primary focus on relapse reduction, while continuing to generate safety and tolerability data, which we hope will be in line with the favorable profile observed to date.

EB: What could positive ENSURE data mean for the future of vidofludimus calcium?

Lundgren: If the ENSURE trials deliver positive results, our immediate next step would be to finalize the preparations and submit a New Drug Application (NDA). We have already engaged extensively with regulators and continue to maintain an ongoing open dialogue.

From a commercial perspective, we believe vidofludimus calcium could be well positioned in the relapsing MS market if we are able to reproduce the efficacy, safety and tolerability results observed in our Phase 2 program. As we discussed earlier, patients and physicians continue to need new treatment options that combine efficacy with a favorable safety and tolerability profile.

An oral route of administration, combined with strong relapse control and the favorable safety profile observed to date, could represent a differentiated value proposition for relapsing MS patients. We believe that would provide a meaningful opportunity in the market, even in a treatment landscape with multiple approved drugs.

EB: Looking beyond the initial relapsing MS opportunity, where do you see the greatest long-term potential for vidofludimus calcium?

Lundgren: We see several opportunities beyond the relapsing MS market. MS is a chronic disease in which patients cycle through different therapies over time. For example, around 10% of patients discontinue anti-CD20 treatment each year, creating an ongoing need for additional treatment options. We believe vidofludimus calcium could be relevant for several patient groups, including newly diagnosed patients, patients looking for an oral alternative to switch to and those seeking a treatment with a favorable safety and tolerability profile.

We are also seeing an aging MS population. As patients age, immune senescence becomes increasingly relevant. You cannot continue intensifying immune suppression indefinitely, which is why treatment goals and patient needs evolve over time.

At the same time, the progressive component of the disease becomes increasingly important. This is where we see a particularly compelling long-term opportunity. Significant unmet needs remain in progressive MS, and our planned progressive MS Phase 3 program will help us further explore the potential of vidofludimus calcium in this setting. If successful, it could provide an important point of differentiation for the drug.

EB: You mentioned progressive MS as an important future development area for vidofludimus calcium. Why is progression such a critical challenge in MS, and why has it proven so difficult to address?

Lundgren: One of the key learnings in MS over the past decade is that the traditional distinction between relapsing and ­progressive disease becomes less clear. Current therapies have transformed the treatment landscape, and the waiting rooms are no longer full of patients in wheelchairs, which is a remarkable achievement.

At the same time, we have come to recognize that progression remains a fundamental part of the disease. Many patients eventually enter a progressive phase, where relapses become less prominent or stop altogether, but disability continues to worsen. In other words, while the inflammatory component of the disease may decline over time, the progressive component remains and often increases over time.

That is why neuroprotection is emerging as one of the most important areas of innovation in MS today, and why we believe approaches that can potentially address both inflammation and neurodegeneration warrant close attention.

EB: As Immunic prepares for commercialization, how do you envision bringing vidofludimus calcium to patients globally?

Lundgren: Our ambition is to build a ­successful commercial organization and bring vidofludimus calcium to patients ourselves in the core MS markets, first in North America. At the same time, we will carefully evaluate the opportunities and requirements of different healthcare systems and regions around the world.

We have already begun preparing for this next phase of growth. Earlier this year, we completed a tranched financing backed by strong institutional investors and designed to support our transformation into a fully integrated biotechnology organization. In addition, a second tranche of up to $200 million could become available following ENSURE data. Our current cash position allows us to continue executing on our development priorities.

Ultimately, our focus remains on delivering strong Phase 3 data and preparing the organization to capitalize on the opportunities that could follow.

EB: What else is in Immunic’s pipeline beyond vidofludimus calcium?

Lundgren: We have additional work ongoing around the Nurr1 target with the goal to understand this mechanism and biology even better. While some of its aspects are still a hypothesis, we continue to drive preclinical work to better understand and prove it. Both the preclinical work and the clinical trials will tell us more and we are eager to learn.

EB: As Immunic enters this next phase of its development, what is your vision for the company?

Lundgren: What motivates me every day is the opportunity to disrupt MS once again and ultimately improve the quality of life for patients. Over the past decades, tremendous progress has been made, but significant unmet needs remain, particularly when it comes to disability progression and long-term safety. The possibility of making a meaningful difference for patients is what drives me and our team every day.

My vision is for Immunic to become the company that understands MS patients better than anyone else. That should be our superpower. Patients’ needs evolve throughout the course of the disease, and our responsibility is to understand those needs and develop solutions that truly address them.

We are evolving from a science-driven biotechnology company into a fully integrated organization. But I do not see science and commercialization as competing priorities. Commercialization is the natural extension of great science. Scientific innovation only achieves its full value when it reaches patients.

If we can combine scientific excellence with a deep understanding of patients and execute successfully as a commercial organization, I believe Immunic has the opportunity to become a true disruptor in MS.