Immunic Showcases Crucial Vidofludimus Calcium Data at ECTRIMS Congress, Highlighting MS Therapeutic Potential

Immunic, Inc., a biotechnology firm listed on Nasdaq under the ticker IMUX, has unveiled significant data highlighting the therapeutic potential of its leading drug candidate, vidofludimus calcium (IMU-838), at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The event is taking place in Copenhagen, Denmark from September 18 to 20, 2024. The data will be presented through an oral poster presentation and three ePosters, with Immunic's team available at booth #60 throughout the conference.

Daniel Vitt, Ph.D., CEO of Immunic, expressed enthusiasm regarding the presence of multiple poster presentations for vidofludimus calcium at ECTRIMS. He emphasized the drug's potential as a new treatment option for multiple sclerosis (MS), citing various aspects of its profile including neurofilament light chain (NfL) data from the phase 2 CALLIPER trial, antiviral data, Nurr1 target data supporting neuroprotective properties, and pathogenic T cell data supporting anti-inflammatory effects.

Dr. Vitt highlighted that interim analyses of the CALLIPER trial displayed a clear differentiation from placebo in serum NfL levels among patients with progressive multiple sclerosis (PMS) and its subtypes. These results indicate the drug's potential in slowing disease progression in PMS, supported by its activation of Nurr1. Immunic anticipates releasing top-line data from the CALLIPER trial in April next year, which, if positive, could allow vidofludimus calcium to stand out from other MS treatments due to its strong safety and tolerability profile.

Dr. Vitt also addressed fatigue, a common and debilitating symptom in both post-COVID syndrome (PCS) and MS. Third-party research links Epstein-Barr virus (EBV) reactivation to PCS fatigue. Vidofludimus calcium has demonstrated potential in preventing EBV reactivation, which could contribute to fatigue reduction in MS patients. This potential will be further explored in the ongoing CALLIPER, phase 3 ENSURE, and the recently initiated phase 2 RAPID_REVIVE trials.

Preclinical data suggest that vidofludimus calcium promotes neuronal survival via Nurr1 activation. The drug has shown the ability to reduce or prevent the development of pathogenic peripheral T helper cells, a key factor in MS treatment. The combination of neuroprotective and anti-inflammatory effects of vidofludimus calcium offers a promising profile for effective MS treatment.

The oral poster presentation titled "Serum Neurofilament Changes in Progressive MS: Exploring the Impact of Vidofludimus Calcium by Age and Disability in the CALLIPER Study Interim Analysis" will be presented by Dr. Robert J. Fox from the Cleveland Clinic. The interim analysis of 203 patients showed a 22.4% reduction in serum NfL levels after 24 weeks of treatment with vidofludimus calcium compared to placebo. The data indicated consistent treatment effects across different subtypes of progressive MS and various patient subgroups based on age and disability scores.

Additionally, ePosters will explore the potential of vidofludimus calcium in reducing fatigue in MS by preventing EBV reactivation, its neuroprotective function through Nurr1 activation, and its modulatory effects on T helper cells in a murine model of experimental autoimmune encephalomyelitis (EAE). These data collectively underscore the multifaceted therapeutic potential of vidofludimus calcium in treating MS.

Vidofludimus calcium is an investigational oral drug designed to treat multiple sclerosis and other chronic inflammatory and autoimmune diseases. It functions as a selective immune modulator by activating the Nurr1 transcription factor for neuroprotection and inhibiting the enzyme dihydroorotate dehydrogenase (DHODH), which is involved in the metabolism of overactive immune cells and virus-infected cells. The drug has shown promise in selectively targeting hyperactive T and B cells while preserving normal immune function, thereby offering a potential new treatment option for MS.