DGAP-News: Immunic, Inc. Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19
Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19
DGAP-News: Immunic, Inc. / Key word(s): Study Immunic, Inc. Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19 15.06.2020 / 12:30 The issuer is solely responsible for the content of this announcement. Immunic, Inc. Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19 NEW YORK, June 15, 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 dosing of the first patients in its phase 2, CALVID-1 clinical trial of IMU-838, the company's selective oral DHODH inhibitor, in coronavirus disease 2019 (COVID-19), at several sites in different European countries. Patients will be enrolled at 10 to 35 centers in Germany, the United States and a half dozen European countries. CALVID-1 recently received regulatory allowance from the German health authority, BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), from the U.S. Food and Drug Administration (FDA) and from regulatory authorities 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. "Dosing of the first patients in our CALVID-1 trial represents a key milestone in advancing our lead asset, IMU-838, as a potential, novel treatment option for COVID-19," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Moreover, the CALVID-1 trial is an important strategic expansion of our clinical development of IMU-838 and adds another near-term data readout to our pipeline." Andreas Muehler, M.D., Chief Medical Officer of Immunic, noted, "Backed by strong preclinical data and a unique profile, IMU-838 has the potential to become an important therapy for treating COVID-19. We expect to include approximately 230 hospitalized COVID-19 patients to evaluate IMU-838's efficacy, safety and tolerability. An efficacy interim analysis is scheduled after approximately 200 patients have been enrolled. If activity is shown in this interim analysis, our goal is to expand into a confirmatory phase 3 trial using an adaptive trial design." For more information on this clinical trial, please visit: www.clinicaltrials.gov, NCT04379271. About IMU-838 About Immunic, Inc. Cautionary Statement Regarding Forward-Looking Statements Contact Information US IR Contact US Media Contact
15.06.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
1069611 15.06.2020