Immunic, Inc. has announced the enrollment of the first patient in a Phase 2 clinical trial evaluating vidofludimus calcium (IMU-838) for the treatment of Post COVID Syndrome (PCS). The trial, titled "Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE)," is investigator-sponsored and aims to assess the drug's efficacy in alleviating PCS symptoms, particularly fatigue and impaired physical function.
The RAPID_REVIVE trial is a randomized, placebo-controlled, double-blind study led by Prof. Dr. Maria J.G.T. Vehreschild at the University Hospital Frankfurt. Funded by the German Federal Ministry of Education and Research (BMBF), the trial plans to enroll 376 patients across 11 clinical sites in Germany. Participants will be randomized to receive either vidofludimus calcium or a placebo. The primary endpoint is the change in physical function, measured by the Short Form-36 Physical Function (SF-36-PF) scale, from baseline to day 56.
Vidofludimus Calcium: Mechanism and Rationale
Vidofludimus calcium is an oral small molecule that acts as a selective immune modulator. It activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1) and inhibits dihydroorotate dehydrogenase (DHODH), an enzyme involved in the metabolism of overactive immune cells and virus-infected cells. This dual mechanism contributes to its anti-inflammatory and antiviral effects.
The rationale for using vidofludimus calcium in PCS stems from its potential to address Epstein-Barr virus (EBV) reactivation, which has been identified as a possible cause of fatigue in PCS patients. Studies have shown that EBV reactivation is observed in a significant proportion (55-95%) of PCS patients. A recent study found detectable EBV DNA in throat washes of 50% of PCS patients experiencing fatigue, compared to 20% of those without fatigue.
Prior Clinical Evidence
Immunic's previous Phase 2 CALVID-1 trial in COVID-19 patients showed a lower prevalence of post-COVID fatigue in patients treated with vidofludimus calcium. Specifically, 80% of patients who received placebo reported fatigue, compared to 50% who received 45 mg of vidofludimus calcium. While fatigue decreased in both groups over time, the vidofludimus calcium group consistently reported lower fatigue levels.
Implications for Multiple Sclerosis
Notably, fatigue is also a common and debilitating symptom in multiple sclerosis (MS). Given the observed suppression of EBV reactivation by vidofludimus calcium in in vitro experiments, the potential reduction of fatigue in PCS patients may extend to MS patients as well. Immunic is currently investigating signs of EBV reactivation and patient-reported fatigue in ongoing clinical trials of vidofludimus calcium in relapsing and progressive MS.
Daniel Vitt, Ph.D., CEO of Immunic, stated, "We aim to confirm the ability of vidofludimus calcium to influence fatigue and EBV reactivation in our ongoing MS trials and look forward to receiving additional data from the RAPID_REVIVE trial. It is our belief that this may create yet another differentiating feature for this product candidate."
