First Patient Enrolled in Phase 2 Trial of Vidofludimus Calcium for Post COVID Syndrome

Immunic, Inc., a biotechnology firm based in New York, has announced that the first patient has been enrolled in a phase 2 clinical trial for its lead drug candidate, vidofludimus calcium (IMU-838). This trial, named "RAPID_REVIVE," aims to evaluate the drug as a treatment for Post COVID Syndrome (PCS), focusing on its potential to reduce inflammation and alleviate fatigue, a predominant symptom among PCS patients.

Professor Dr. Maria J.G.T. Vehreschild, Head of the Department of Infectious Diseases at the University Hospital Frankfurt, emphasized the urgent need for effective PCS treatments. She highlighted vidofludimus calcium’s antiviral and anti-inflammatory properties, along with its potential to prevent Epstein-Barr virus (EBV) reactivation, as key reasons for its selection in the trial.

Daniel Vitt, Ph.D., CEO of Immunic, expressed pride in having their drug chosen for the trial by well-regarded investigators in Germany. He noted that previous studies have shown vidofludimus calcium’s effectiveness in reducing fatigue and its antiviral capabilities. Vitt also underscored that EBV reactivation is considered a potential cause of fatigue in PCS and multiple sclerosis (MS) patients, and they aim to confirm the drug's ability to mitigate these effects in their ongoing trials.

Fatigue is a common and debilitating symptom for both PCS and MS patients, significantly affecting their quality of life. Recent studies have shown that EBV reactivation is a significant risk factor for fatigue in PCS patients, with 55-95% of them showing signs of the virus reactivating. In a specific study, 50% of fatigued PCS patients had detectable EBV DNA in throat washes compared to 20% of those without fatigue.

Vidofludimus calcium is currently progressing through phase 3 and phase 2 trials for relapsing and progressive MS, respectively. Preclinical studies demonstrated that the drug effectively reduces EBV reactivation in B cells and lytic EBV production in Akata cells. A post-hoc analysis from a previous phase 2 CALVID-1 trial indicated a significant decrease in fatigue among COVID-19 patients treated with vidofludimus calcium. Notably, only 50% of patients treated with the drug reported fatigue, compared to 80% who received a placebo. Over subsequent weeks, fatigue levels dropped to 17% for the drug group and 33% for the placebo group. These findings suggest that the drug's ability to suppress EBV reactivation could extend to MS patients as well.

The RAPID_REVIVE trial, identified by the EudraCT number 2024-511628-16-00, is being led by Prof. Dr. Vehreschild and sponsored by Goethe University Frankfurt, with funding from the German Federal Ministry of Education and Research. Immunic is supplying the study medication for the trial, which aims to enroll 376 patients across 11 German clinical sites. After a 7-day screening period, patients will be randomized to receive either vidofludimus calcium or a placebo, followed by a response-adaptive randomization procedure. The trial includes a 28-day follow-up period, with its primary endpoint being the change in physical function as measured by the SF-36 Physical Function scale from baseline to day 56. Secondary endpoints will assess mental and physical health, fatigue severity, and cognitive function.

Vidofludimus calcium is a promising investigational drug designed to treat multiple sclerosis and other chronic inflammatory and autoimmune diseases. As a selective immune modulator, it targets the neuroprotective transcription factor Nurr1 and inhibits the enzyme dihydroorotate dehydrogenase (DHODH), offering both anti-inflammatory and antiviral benefits. To date, it has been tested in over 1,800 individuals, displaying a strong safety and tolerability profile. However, it is not yet licensed or approved in any country.

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