Immunic Inc (NASDAQ:IMUX) chief operating officer Jason Tardio talked with Proactive about the company’s participation at the BIO International Convention in Boston and recent clinical developments.
Tardio highlighted Immunic’s ongoing business development efforts, particularly around its lead asset, vidofludimus calcium, aimed at treating multiple sclerosis (MS).
Proactive: Hello you’re watching Proactive, joining me is Immunic chief operating officer Jason Tardio. Jason, very good to speak with you. And you're joining us from the BIO International Convention in Boston right now. So tell us a bit about the conference, what it is about and what Immunic’s goals are for the event?
Jason Tardio: Sure. Well, thank you for having me. The BIO International Convention is one of the largest global events for the biotech industry. It brings together over 20,000 biotech and biopharma leaders from across the world to network, partner, and discuss the latest innovations and trends. Specifically for Immunic Therapeutics, our goals include continuing business development and partnering discussions. We’re particularly focused on vidofludimus calcium, our late-stage asset with positive results in multiple sclerosis, and we’re also talking about IMU-856, a phase two-ready asset targeting GI conditions via SIRT-6 modulation. We're here to network, learn, and stay informed.
As you mentioned, your MS program is in focus. Jason, remind us how your asset, vidofludimus calcium, is targeted to make a difference for MS patients?
Vidofludimus calcium is the first dual-mechanistic approach to address both neuroinflammation and neurodegeneration in MS. It's a highly selective inhibitor of DHODH, delivering anti-inflammatory effects, and it activates Nurr1, a nuclear receptor associated with neuroprotection. Our aim is to provide a safe, effective oral treatment covering the full spectrum of MS.
Jason, you recently reported data from your phase 2 CALLIPER trial in progressive MS. How did this data underline vidofludimus calcium’s positioning?
The trial involved 467 patients. Vidofludimus calcium showed a 24% reduction in 24-week confirmed disability worsening compared to placebo. In primary progressive MS, the reduction was 33%, 19% in non-active secondary progressive MS, and 34% in active secondary progressive MS. Remarkably, we also saw benefits in patients without inflammatory disease activity—up to a 35% reduction in primary progressive MS. This is a differentiated data set confirming Nurr1 activation’s neuroprotective benefits.
You also have your phase three ENSURE trials ongoing. Jason, can you tell us about the latest there?
The ENSURE 1 and 2 trials have fully enrolled over 1,100 patients each. We're evaluating vidofludimus calcium’s impact in relapsing MS, primarily looking at time to first relapse and secondary outcomes like confirmed disability progression and MRI biomarkers. Topline data is expected in late 2026.
And the next steps for the program?
We’ll continue operational execution and data collection for the ENSURE trials. Additionally, we plan to share long-term safety and efficacy data from our EMPhASIS open-label extension study at upcoming medical conferences.
Coming back to the BIO Congress, any dominating topics worth highlighting?
There’s a big focus on innovation and patient-centric strategies. The biotech funding environment is challenging, so there's a lot of sharing of ideas and strategies. Immunic is excited to be part of this community and committed to addressing unmet medical needs.
Quotes have been lightly edited for clarity and style