#IMUX "announced the results of 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 coronavirus disease 2019 (COVID-19). Based on the available safety data, an Independent Data Monitoring Committee (IDMC) has concluded that the 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.
During this interim safety analysis, all available study safety results were unblinded to the members of the IDMC, while the company, investigators and enrolled patients remained blinded and no unblinded data has been shared with Immunic. As pre-defined in the study protocol, the analysis was based on data from only a relatively small number of patients in the CALVID-1 trial, and no formal statistical analysis was performed. It was not designed to be a futility analysis nor was any assessment of efficacy done. This interim safety analysis and the conclusions made by the IDMC may not reflect results of a final analysis of the trial once the full data set is analyzed.
“The IDMC’s recommendation to continue our CALVID-1 trial, without changes, is another important milestone in the development of IMU-838 as a potential treatment option for patients with COVID-19,” stated Andreas Muehler, M.D., Chief Medical Officer of Immunic. “Interest in the study is strong, with a total of 110 patients already enrolled. We plan to report the results of a pre-planned unblinded interim analysis of all available efficacy, biomarker and virus titer data later this year, once approximately 200 patients have been treated, after which we will be able to evaluate whether an expansion of the program into a confirmatory phase 3 trial is warranted.”
(see press release HERE)
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