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Tuesday, June 09, 2020

Immunic, Inc. Announces U.S. Food and Drug Administration Allowance of its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19


Immunic, Inc. Announces U.S. Food and Drug Administration Allowance of its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19


NEW YORK, June 9, 2020 – Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced receipt of regulatory allowance from the U.S. Food and Drug Administration (FDA) to initiate its phase 2, CALVID-1 clinical trial of IMU-838, the company’s selective oral DHODH inhibitor, in coronavirus disease 2019 (COVID-19) at centers in the United States.

CALVID-1 received regulatory allowance from the German health authority, BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), on May 13, 2020 and has subsequently also received regulatory allowance in other European countries involved in the study. It is a prospective, multicenter, randomized, placebo-controlled, double-blind clinical trial in patients with moderate COVID-19, designed to evaluate efficacy, safety and tolerability of IMU-838. Top-line data is expected to be available later this year.

For more information on this clinical trial, please visit: www.clinicaltrials.gov, NCT04379271.

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