DGAP-News: Immunic, Inc. / Key word(s): Study
Immunic, Inc. Announces 200 Patients Enrolled in Its Phase 2 CALVID-1 Trial of IMU-838 for the Treatment of Moderate COVID-19, Allowing for Main Phase 2 Efficacy Analysis to Proceed
- Top-Line Data Expected in Q1 2021 -
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.
"Enrollment of 200 patients in the phase 2 part of our CALVID-1 trial is another notable achievement for our lead asset, IMU-838, and comes on the heels of the previously announced interim safety results that supported continuation of this trial without modifications," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "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."
Andreas Muehler, M.D., Chief Medical Officer of Immunic, added, "We greatly appreciate the strong support we have received from both our clinical investigators and site study teams during such a challenging and unprecedented period. The Immunic team is extremely pleased with the speed at which the trial has enrolled, which is a direct result of the symbiotic partnership we have built with our investigators and local clinical Contract Research Organizations."
For more information on this clinical trial, please visit: www.clinicaltrials.gov, NCT04379271.
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02.11.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.