NEW YORK, Nov. 2, 2020 /PRNewswire/ — Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced that the company 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 disease 2019 (COVID-19). The aim of the CALVID-1 trial is to investigate IMU-838 as an oral treatment option for moderate COVID-19 and to support potential use of IMU-838 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 using a single global protocol with clinical sites in the United States, Germany and a range of other European countries.
The current part of CALVID-1 is defined as a phase 2 proof-of-activity trial. As per the protocol, approximately 200 patients were to be included in order to perform a main efficacy analysis which will be used, in consultation between Immunic and an Independent Data Monitoring Committee (IDMC), to assess clinical activity of IMU-838 in moderate COVID-19 based on pre-defined criteria. No formal statistical analysis was pre-specified for this main analysis and all endpoints will be analyzed descriptively. Enrollment continues while the analysis is being prepared. Apart from assessing the clinical activity of IMU-838, the main analysis of the phase 2 part of the CALVID-1 trial may also be used for sample size determination, endpoint selection and potential other trial adjustments in order to continue with a confirmatory phase 3 trial, if such continuation is warranted. The final design of the phase 3 portion will be submitted as a protocol amendment to regulatory authorities.