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Immunic, Inc. Receives First Regulatory Approval from German Health Authority BfArM to Initiate a Phase 2 Clinical Trial of its Selective Oral DHODH Inhibitor, IMU-838, in COVID-19 Patients
NEW YORK, May 13, 2020 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral
About this update from Immunic, Inc.
[{"type":"text","content":"NEW YORK, May 13, 2020 /PRNewswire/ -- 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 that it has received first regulatory approval from Germany's BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) to initiate a phase 2 clinical trial of its selective oral DHODH inhibitor, IMU-838, in coronavirus disease 2019 (COVID-19). The CALVID-1 study is a prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 clinical trial in approximately 230 patients with moderate COVID-19, designed to evaluate efficacy, safety and tolerability of IMU-838. Dosing of the first patient is expected to occur later this month. Top-line data is expected to be available later this year.\n\"Approval to begin the CALVID-1 phase 2 clinical trial in Germany is a significant achievement that will allow for the near-term investigation of the oral DHODH inhibitor, IMU-838, in COVID-19 patients,\" commented Prof. Maria Vehreschild, M.D., Head of Infectious Diseases at University Hospital Frankfurt and Principal Investigator of one of the clinical sites participating in the study. \"Given IMU-838's broad antiviral effect, recently confirmed preclinical activity against SARS-CoV-2 itself, as well as its selective effect against hyper-activated immune cell populations which may play a role in the potentially deadly complications of interstitial lung disease, IMU-838 represents a prospective, potential treatment option that merits urgent investigation.\"\nImmunic recently announced that IMU-838 had successfully demonstrated preclinical activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Specifically, IMU-838 was observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with COVID-19. In cellular assays, IMU-838 demonstrated this antiviral activity at concentrations which are well below the blood concentrations associated with IMU-838 dosing regimens studied in ongoing and previous clinical trials. In addition, IMU-838 has an attractive pharmacokinetic, safety and tolerability profile and, to date, has already been tested in about 650 individuals.\nThe aim of the CALVID-1 trial is to investigate IMU-838 as an oral treatment option for ...