Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the presentation of data on its lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in two poster presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025, taking place from February 27 to March 1, in West Palm Beach, Florida.
“Having two poster presentations on vidofludimus calcium at the prestigious ACTRIMS Forum highlights the unique importance of our drug candidate and its promise as a potential new treatment option for multiple sclerosis (MS),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “For the first time, we analyzed the baseline characteristics of patients in subpopulations from our phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), and compared to those from four major PMS trials. The goal of this analysis was to identify how the differences may impact comparability of trial outcomes, including our top-line data readout of the phase 2 CALLIPER trial, expected in April. The CALLIPER data is expected to provide valuable insights into the effects of vidofludimus calcium in a non-active PMS population. We believe any impact of vidofludimus calcium on 24-week confirmed disability worsening in this group would likely primarily reflect its influence on compartmentalized pathology within the central nervous system, expressed clinically as progression independent of relapse activity (PIRA).”
Presentation Details:
- Poster Title: Baseline Characteristics Across Major Clinical Trials in Progressive Multiple Sclerosis: Insights from ORATORIO, EXPAND, MS-STAT2, HERCULES, and CALLIPER
- Presenting Author: Robert J. Fox, M.D., Staff Neurologist, Mellon Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio
- Abstract Number: 452
- Poster Number: P102
- Poster Session: 1
- Session Date: Thursday, February 27, 2025
- Session Time: 6:00 pm – 7:30 pm ET (even-numbered posters present from 6:00-6:45 pm)
Hella Kohlhof, PhD., Chief Scientific Officer of Immunic, continued, “Our second poster highlights, via a series of both in vitro and in vivo experiments, evidence of the neuroprotective potential of vidofludimus calcium through its activation of the transcription factor Nurr1. Overall, the data from these preclinical studies underlines that vidofludimus calcium reduces neuronal loss and injury directly and indirectly by decreasing microglial activation and that its potential neuroprotective effects are most likely mediated by Nurr1.”
Presentation Details:
- Poster Title: Vidofludimus Calcium Shows a Potential Neuroprotective Function in Multiple Sclerosis through its Activity on Nurr1 in Preclinical Models
- Presenting Author: Evelyn Peelen, Ph.D., Head of Research, Immunic
- Abstract Number: 427
- Poster Number: P317
- Poster Session: 2
- Session Date: Friday, February 28, 2025
- Session Time: 6:00 pm – 7:30 pm ET (odd-numbered posters present from 6:45-7:30 pm)
Both poster presentations will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.
About Vidofludimus Calcium (IMU-838)
Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor-related 1 (Nurr1), which is associated with direct neuroprotective effects. Additionally, vidofludimus calcium is a highly selective inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country.
