Immunic Enrolls 200 Patients In Phase 2 CALVID-1 Trial Of IMU-838 - Quick Facts

(RTTNews) - Immunic, Inc. (IMUX), said Monday it has enrolled and randomized 200 patients, pre-specified in the protocol as sufficient to perform the main efficacy analysis of the phase 2 part of the CALVID-1 trial, for its selective oral DHODH inhibitor, IMU-838, in hospitalized patients with moderate coronavirus or COVID-19.

Immunic noted that the aim of the CALVID-1 trial is to investigate IMU-838 as an oral treatment option for moderate COVID-19 and to support its potential use as a treatment for current and potential future viral pandemic threats.

The trial is being conducted under an investigational new drug application granted by the U.S. Food and Drug Administration or FDA using a single global protocol with clinical sites in the U.S., Germany and other European countries.

"Given the established broad antiviral activity of IMU-838 in multiple virus strains as well as different cell cultures infected with SARS-CoV-2, we look forward to the findings of the main efficacy analysis of the phase 2 part of our CALVID-1 trial, which is expected to be available in the first quarter of 2021, after which we will be able to evaluate whether the program may be expanded into a confirmatory phase 3 trial," said Daniel Vitt, Chief Executive Officer and President of Immunic.

The current part of CALVID-1 is defined as a phase 2 proof-of-activity trial. As per the protocol, about 200 patients are to be enrolled in order to perform a main efficacy analysis which will be used, in consultation between Immunic and an Independent Data Monitoring Committee or IDMC, to assess clinical activity of IMU-838 in moderate COVID-19 based on pre-defined criteria.

According to Immunic, no formal statistical analysis was pre-specified for this main analysis and all endpoints will be analyzed descriptively.

In addition to assessing the clinical activity of IMU-838, the main analysis of the phase 2 part of the CALVID-1 trial may also be used to determine sample size, selection of endpoints and potential other trial adjustments required to continue with a confirmatory phase 3 trial, if such continuation is warranted.

Immunic said it will submit the final design of the phase 3 portion of the trial as a protocol amendment to regulatory authorities.