Germany’s BfArM approves Covid-19 trial by Immunic

14th May 2020 (Last Updated May 15th, 2020 14:16)

Biopharmaceutical company Immunic has secured regulatory approval from Germany’s BfArM to conduct a Phase II clinical trial, CALVID-1, of IMU-838 in Covid-19 patients.

Germany’s BfArM approves Covid-19 trial by Immunic
This illustration, created at the CDC, reveals ultrastructural morphology exhibited by the 2019 novel coronavirus. Credit: CDC/ Alissa Eckert, Dan Higgins.

Biopharmaceutical company Immunic has secured regulatory approval from Germany’s BfArM to conduct a Phase II clinical trial, CALVID-1, of IMU-838 in Covid-19 patients.

IMU-838 is an oral selective immune modulator designed to block the intracellular metabolism of activated immune cells by inhibiting the dihydroorotate dehydrogenase (DHODH) enzyme .

The prospective, multi-centre, randomised, placebo-controlled, double-blind CALVID-1 trial will assess efficacy, safety and tolerability of IMU-838 in around 230 patients with moderate Covid-19 at 10-35 sites in Europe and the US.

Dosing is set to start this month, with top-line results expected later this year.

Immunic chief medical officer Andreas Muehler said: “IMU-838’s profile, as an orally available DHODH inhibitor that employs a host-based mode of action, thereby providing broad-spectrum antiviral activity, makes it a unique, potential therapeutic option, which may be applicable as either a standalone or combination therapy.

“All Phase II preparatory activities have been completed and we anticipate beginning the trial in short order.”

The company said that IMU-838 demonstrated preclinical activity against SARS-CoV-2, which causes Covid-19. It was found to prevent replication of clinical isolates of the virus.

As well as an oral treatment for Covid-19, CALVID-1 is expected to allow the use of IMU-838 to treat current and any future pandemic threats. Patients will be given 22.5mg of IMU-838 or placebo twice daily, for 14 consecutive days.

The primary endpoint will be the proportion of patients not requiring invasive ventilation during the study period. Secondary endpoints include duration of hospitalisation and intensive care unit (ICU) treatment, 28-day all-cause mortality, time to clinical improvement and viral titer reduction.

If clinical activity of IMU-838 is validated by the Independent Data Monitoring Committee, the trial could be expanded into a confirmatory Phase III study.