Immunic Begins Phase 2 Trial of Vidofludimus Calcium for Post COVID Syndrome

Immunic, Inc., a biotechnology firm specializing in oral therapies for chronic inflammatory and autoimmune diseases, has announced the enrollment of the first patient in a phase 2 clinical trial for its key drug, vidofludimus calcium (IMU-838). This study, titled "Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE)", is sponsored by Goethe University Frankfurt and funded by a German government grant.

Prof. Dr. Maria J.G.T. Vehreschild, head of the Department of Infectious Diseases at the University Hospital Frankfurt, emphasized the urgent need for treatments addressing Post COVID Syndrome (PCS) and its associated physical and fatigue symptoms. According to her, vidofludimus calcium, with its antiviral and anti-inflammatory properties, is well-suited for this trial, given its potential to prevent Epstein-Barr virus (EBV) reactivation and alleviate fatigue.

Daniel Vitt, Ph.D., CEO of Immunic, expressed pride in the selection of vidofludimus calcium for this trial conducted by esteemed German institutions. He noted substantial data supporting the drug’s antiviral effectiveness and its capacity to reduce fatigue, as observed in a previous phase 2 CALVID-1 trial. Vitt highlighted that third-party research has linked EBV reactivation to fatigue in both PCS and multiple sclerosis (MS) patients, impacting their quality of life. Immunic aims to validate vidofludimus calcium’s influence on fatigue and EBV reactivation through this study and ongoing MS trials.

Fatigue is the most common symptom among PCS patients and significantly affects MS patients' lives. Research has pinpointed EBV reactivation as a significant risk factor for fatigue in PCS patients, with studies showing EBV DNA in 50% of fatigued PCS patients compared to 20% in non-fatigued individuals.

Vidofludimus calcium is currently undergoing phase 3 and phase 2 trials for relapsing and progressive MS, respectively. Preclinical studies have demonstrated its capability to reduce lytic EBV reactivation in B cells and EBV production in Akata cells. A post-hoc analysis from the CALVID-1 COVID-19 trial indicated that patients receiving vidofludimus calcium reported less fatigue compared to those on placebo.

The RAPID_REVIVE trial (EudraCT number: 2024-511628-16-00) is a randomized, double-blind, placebo-controlled study led by Prof. Dr. Vehreschild. Sponsored by Goethe University Frankfurt and financially supported by the German Federal Ministry of Education and Research, the study will enroll 376 patients across 11 sites in Germany. Participants will be randomly assigned to receive either vidofludimus calcium or a placebo, with a primary endpoint focusing on changes in physical function as measured by the SF-36-PF score from baseline to day 56. Secondary endpoints will assess mental and physical health, fatigue severity, mental disorder symptoms, and cognitive function.

Vidofludimus calcium, an oral small molecule, is under investigation as a next-generation treatment for MS and other chronic inflammatory and autoimmune conditions. It activates the neuroprotective transcription factor Nurr1 and inhibits the enzyme dihydroorotate dehydrogenase (DHODH), which is involved in the metabolism of overactive immune and virus-infected cells. This dual mechanism underpins the drug’s anti-inflammatory and antiviral effects. To date, over 1,800 individuals have been treated with vidofludimus calcium, demonstrating a favorable safety and tolerability profile. The drug is not yet approved in any country.

Immunic, Inc., listed on Nasdaq (IMUX), continues to develop its clinical pipeline, with vidofludimus calcium at the forefront, currently in phase 3 and phase 2 trials for various stages of MS, and showing promise in earlier studies for ulcerative colitis.