US FDA clears vidofludimus for phase 2 trial to treat COVID-19

US FDA clears vidofludimus for phase 2 trial to treat COVID-19

Vidofludimus calcium (IMU-838), an oral, selective immune modulator has received a nod from the US FDA for entering phase 2 clinical trial for treating COVID-19, Immunic announced.

Vidofludimus calcium is designed to block the intracellular metabolism of activated immune T and B cells and cytokines by inhibiting the dihydroorotate dehydrogenase (DHODH) enzyme thereby reducing inflammation.

DHODH inhibitors are considered to exhibit a host-based antiviral effect. IMU-838’s antiviral activity against the SARS-CoV-2 combined with a selective immunomodulatory effect against highly activated immune cells may be a promising profile for the treatment of COVID-19, the company said.

The drug is evaluated for improving symptoms, preventing worsening and the need for further treatments, such as ventilation helping lower virus number when given along with the prescribed standard therapy.

The phase 2 trial named CALVID-1 is randomised, placebo-controlled, double-blind clinical trial including 230 COVID-19 positive patients suffering from moderate symptoms. The results from the study are anticipated to be available later this year. The trial is estimated to be completed in October.