Immunic Inc (NASDAQ:IMUX) chief operating officer Jason Tardio joined Proactive to discuss the company’s progress in advancing its novel therapy vidofludimus calcium.
He discussed the significant milestones achieved in 2024, such as the positive interim analysis of the ENSURE trials in relapsing multiple sclerosis (MS) and the anticipation of the results from the CALLIPER progressive MS study in April 2025.
Proactive: Hello, you're watching Proactive. I'm joined by Immunic chief operating officer Jason Tardio. Jason, very good to meet you, and Happy New Year. You joined Immunic about six months ago, in July last year. Tell us about your start, how the first months went, and what made you actually join Immunic?
Jason Tardio: Happy New Year to you as well, and thank you for having me. It's been a wonderful six months. It's been, as you can imagine, a busy six months. It's a dynamic organization. There's lots going on in Immunic—wonderful things, like advancing our lead program in vidofludimus calcium and continuing work on our second clinical program, IMU-856.
But as with any new company, the first six months have really been about taking the time to meet as many people within the company as possible and engaging with the external community, including investors, business development partners, and patient advocacy organizations. It's been a lot to get up to speed, but the experience has confirmed my original thesis for joining the organization.
This company is rooted in three principles: a differentiated pipeline, strong leadership, and patient-centric priorities. Our lead asset, vidofludimus calcium, could transform the multiple sclerosis space, while IMU-856, targeting Sirtuin 6, has potential in GI conditions like celiac disease. The leadership team and broader organization are strong, focused, and capable. Lastly, Immunic prioritizes patients, developing medicines for high unmet needs.
2024 had several exciting milestones for Immunic. Could you walk us through the highlights, please?
It's been a very successful year. One of the most significant developments was the positive interim analysis of our Phase 3 ENSURE program for relapsing forms of multiple sclerosis. The independent data monitoring committee confirmed that the trials are not futile and recommended continuing them as planned.
We’ve expanded our scientific and medical footprint through publications, presentations at major conferences, and hosting R&D days to educate investors. Our visibility in the multiple sclerosis space has grown, especially regarding vidofludimus calcium. We also strengthened our leadership team, including adding Simona Skerjanec, a thought leader in brain health. Additionally, we secured a three-tranche private placement totaling $240 million, solidifying our financial base.
2025 is set to be a key year for Immunic. What can we expect, Jason?
It’s a pivotal year, starting with the CALLIPER study's top-line results in April. This Phase 2 exploratory study investigates vidofludimus calcium in progressive multiple sclerosis, including primary and non-active secondary forms, where treatments are severely limited.
We’ll also continue advancing the ENSURE 1 and ENSURE 2 Phase 3 trials for relapsing multiple sclerosis, with enrollment progressing well.
What makes vidofludimus calcium so special? How could it differentiate you in the MS space?
Vidofludimus calcium has a dual mechanism addressing both neuroinflammation and neurodegeneration, making it suitable for relapsing and progressive MS. It’s a selective DHODH inhibitor with proven anti-inflammatory effects, and it activates Nurr1, providing neuroprotection.
We’ve seen strong results from interim analyses, including reductions in neural filament light levels, a biomarker for neurodegeneration. Unlike other oral therapies, vidofludimus calcium has no black box warnings, offering a favorable safety profile. If successful, it could be the first oral therapy approved for both relapsing and progressive MS.
Quotes have been lightly edited for clarity and style