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.
沒有留言:
發佈留言