On Feb. 17, 2021, Immunic announced that its lead asset, IMU-838, the company’s selective oral DHODH inhibitor, had shown evidence of clinical activity in hospitalized patients with moderate coronavirus disease 2019 (COVID-19).

This planned main analysis of the company’s phase 2 CALVID-1 trial was based on data from 204 randomized patients and includes top-line clinical efficacy, safety, disease marker, and virology data. A final analysis of the complete randomized patient population of 223, which comprise data on all endpoints, including subgroup and sensitivity analyses, was expected to be available in the second quarter of 2021.

The primary endpoint of the randomized, placebo-controlled, double-blind trial was defined as the proportion of patients without any need for invasive ventilation through day 28. In contrast to the relatively high rates of ventilation reported in the first COVID-19 wave in early 2020, the CALVID-1 trial found an actual rate of less than 1% of invasive ventilation for hospitalized patients with moderate COVID-19. This very low event rate, consistent with the findings of many recent third-party trials in COVID-19, prevented the primary endpoint from being evaluable.