Biopharmaceutical company Immunic Inc (Nasdaq:IMUX) on Monday provided a pre-planned interim safety analysis and a recruitment update from the ongoing phase 2 CALVID-1 trial of its selective oral DHODH inhibitor, IMU-838, in patients with moderate COVID-19.

Based on the available safety data, an Independent Data Monitoring Committee (IDMC) has concluded that the ongoing phase 2 CALVID-1 trial study should continue without changes. The IDMC will perform a second safety analysis when additional patient data is available.

To date, 110 patients have been enrolled in the CALVID-1 trial and enrollment is progressing well, added the company.

According to the company, IMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on activated T and B cells while leaving other immune cells largely unaffected and allows the immune system to stay functioning.

The aim of the company's CALVID-1 trial is to investigate IMU-838 as an oral treatment option for COVID-19 as well as enable the use of IMU-838 as a treatment for current and potential future pandemic threats. The trial is expected to initially enroll 230 patients at 10-35 centers across Europe and the US. Patients will be randomized to receive either 22.5 mg of IMU-838 twice daily, or placebo twice daily, for 14 consecutive days. The primary endpoint is the proportion of patients free of invasive ventilation throughout the entire study period.