Immunic Inc (NASDAQ:IMUX) announced that the first patient has been enrolled in an investigator-sponsored Phase 2 trial of its lead asset vidofludimus calcium for post-COVID syndrome.
The RAPID_REVIVE study is sponsored by Goethe University Frankfurt, Germany, with funding received via a grant from the German Federal Ministry of Education and Research.
It is set to enrol 376 patients across 11 clinical sites in Germany.
In addition to providing data on post-COVID syndrome, the study is designed to deliver data on the activity of vidofludimus calcium in suppressing Epstein-Barr Virus (EBV) reactivation and related fatigue symptoms.
"We are honored to have vidofludimus calcium chosen for this investigator-sponsored trial, run by such highly regarded investigators at esteemed institutions in Germany," Immunic CEO Dr Daniel Vitt commented.
"We have seen convincing data supporting vidofludimus calcium's antiviral effects in our preclinical and clinical studies and its ability to reduce fatigue in patients from our phase 2 CALVID-1 trial.”
He highlighted that third-party research has identified EBV reactivation as a potential cause for fatigue, one of the most dominating symptoms for both post-COVID syndrome and multiple sclerosis (MS) patients, which impacts their quality of life.
“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,” the CEO said. “It is our belief that this may create yet another differentiating feature for this product candidate."
Dr Maria Vehreschild, principal investigator and Head of the Department of Infectious Diseases at the University Hospital Frankfurt, added: “Vidofludimus calcium is an ideal candidate for our trial, due to its proven antiviral and anti-inflammatory effects, as well as its potential ability to prevent EBV reactivation and reduce fatigue. We look forward to further enrolling patients in this trial.”