World MS Day Special: Immunic reveals new hope for progressive MS
Episode
27 min
Read time
2 min
Topics
Health & Wellness, Fundraising & VC, Leadership
AI-Generated Summary
Key Takeaways
- ✓IMU-838 dual mechanism: IMU-838 inhibits DHODH (the same target as approved MS drug Tecfidera) but also activates the NR1 nuclear receptor, producing direct neuroprotection beyond standard immunosuppression. Patients and clinicians should understand this distinction: existing MS drugs suppress inflammation but do not directly protect neurons from cell death, leaving progressive patients without effective options.
- ✓Progressive MS gap in treatment: Secondary progressive MS currently has zero approved treatments. IMU-838's NR1 activation mechanism positions it as a candidate for primary and secondary progressive MS, where neurodegeneration continues despite inflammation cooling. Patients transitioning off anti-CD20 therapies — a process taking one to two years for B-cell recovery — represent a specific high-need population.
- ✓Phase two CALIBR trial disability improvement signal: The CALIBR phase two study in progressive MS patients recorded a statistically significant increase in confirmed disability improvement (CDI) — meaning measurable reversal of disability, not merely slowing progression. This outcome is rare in MS trials, which typically measure worsening, and serves as the scientific rationale for the planned phase three progressive MS study.
- ✓Anti-CD20 therapy limitations create switching opportunity: Drugs like Ocrevus deplete B-cells effectively but cannot be used indefinitely — declining IgG levels force physicians to discontinue treatment. IMU-838's non-immunosuppressive profile and antiviral properties make it a candidate switch therapy for patients coming off B-cell depletion, addressing a structural gap in long-term MS disease management.
- ✓Phase three readout timeline and financing: The ENSURE-1 and ENSURE-2 trials, enrolling 2,221 relapsing MS patients combined, are expected to read out by end of 2025. Immunic raised $200 million in February 2025 (first tranche) with a potential additional $200 million tranche to fund NDA submission and commercial launch preparation, providing a defined financial runway through regulatory filing.
What It Covers
Immunic Therapeutics CEO Daniel Witt joins Beyond Biotech on World MS Day to discuss IMU-838, an oral therapy targeting the NR1 nuclear receptor with potential neuroprotective effects in both relapsing and progressive MS, with phase three readouts expected by end of 2025 across 2,221 enrolled patients.
Key Questions Answered
- •IMU-838 dual mechanism: IMU-838 inhibits DHODH (the same target as approved MS drug Tecfidera) but also activates the NR1 nuclear receptor, producing direct neuroprotection beyond standard immunosuppression. Patients and clinicians should understand this distinction: existing MS drugs suppress inflammation but do not directly protect neurons from cell death, leaving progressive patients without effective options.
- •Progressive MS gap in treatment: Secondary progressive MS currently has zero approved treatments. IMU-838's NR1 activation mechanism positions it as a candidate for primary and secondary progressive MS, where neurodegeneration continues despite inflammation cooling. Patients transitioning off anti-CD20 therapies — a process taking one to two years for B-cell recovery — represent a specific high-need population.
- •Phase two CALIBR trial disability improvement signal: The CALIBR phase two study in progressive MS patients recorded a statistically significant increase in confirmed disability improvement (CDI) — meaning measurable reversal of disability, not merely slowing progression. This outcome is rare in MS trials, which typically measure worsening, and serves as the scientific rationale for the planned phase three progressive MS study.
- •Anti-CD20 therapy limitations create switching opportunity: Drugs like Ocrevus deplete B-cells effectively but cannot be used indefinitely — declining IgG levels force physicians to discontinue treatment. IMU-838's non-immunosuppressive profile and antiviral properties make it a candidate switch therapy for patients coming off B-cell depletion, addressing a structural gap in long-term MS disease management.
- •Phase three readout timeline and financing: The ENSURE-1 and ENSURE-2 trials, enrolling 2,221 relapsing MS patients combined, are expected to read out by end of 2025. Immunic raised $200 million in February 2025 (first tranche) with a potential additional $200 million tranche to fund NDA submission and commercial launch preparation, providing a defined financial runway through regulatory filing.
Notable Moment
Witt describes how IMU-838 was originally developed as a selective DHODH inhibitor, but clinical data unexpectedly revealed NR1 activation — a nuclear receptor linked to direct neuroprotection. This serendipitous discovery reframed the molecule's potential from a safer reformulation of existing drugs into a possible first-in-class neuroprotective therapy.
Episode Transcript
Hello, and welcome to Beyond Biotech, the weekly podcast from La BioTech. I'm Dylan Kossain, and this is episode 199 for the podcast. For our two hundredth show next week, we've got something special planned, and you won't wanna miss it. Today, though, I'm delighted to welcome doctor Daniel Witt, CEO of Munich Therapeutics to the show. With World MS Day being tomorrow, the May 30, this is the perfect moment to focus on multiple sclerosis, a disease that affects nearly three million people worldwide and still leaves many patients searching for better options. In today's episode, Daniel shares his own journey into biotechnology, walks us through what life with MS really looks like for patients, and explains the science behind Munich's most advanced program, Immu eight three eight. We discuss what makes Munich's oral therapy different from today's treatments, uncover the latest data from the CALIPR and NURE trials, and talk about the future of MS care. So whether you live with MS, care for someone who does, or simply want to understand the latest progress in neurology, I hope you enjoy my discussion with Daniel Witt. Daniel, welcome to Beyond Biotech. Yeah. Happy to be here today. Daniel, why don't you start by telling us a little bit about your background? What drew you into biotech? What drew you to immunology? Actually, trained as a medicine chemist, it is always it was always my passion to do something good and to translate ideas, technologies, consents into drugs to to treat diseases, and from the very beginning. And it all started at university when I developed, a new technology for insulico screening, which today is AI, basically. And so I had the opportunity to start my first company in in the late nineties. And doing that, that also brought me into the program development into really real drug design and and synthesis. And, and therefore, I I think this this is just continue until today, using my whole professional life. How did you come to join in Munich, and, you know, where have you been focusing there in your role as CEO? Munich is just a logical consequence of my first company for SC where I spent almost nineteen years, translating the technology into into drug development. Because I'm a cofounder of Munich, in the year 2016, and and part of the founding team, team, I was able to buy my favorite molecule from my old company, and to to bring that into Munich as as the crystallization point of starting the company and now bring it into phase three meanwhile. So that that brought me in here. And, the role of the CEO was not, the first thing I thought about, but clearly, if you're passionate about a drug, you need to make sure it's financed properly. So I took over the role of the CEO, and, I I think, really brought the company from from a four people start up to a hundred hundred people phase three …
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