Type: Selective oral novel dihydroorotate dehydrogenase (DHODH) inhibitor
Status: Immunic said June 9 it received FDA allowance to launch the Phase II CALVID-1 trial (NCT04379271), designed to assess the efficacy, safety, and tolerability of IMU-838. Topline data is expected to be released later this year.
In May, Immunic received first regulatory approval from Germany’s BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) to initiate CALVID-1, followed by regulatory allowances in other European nations. The prospective, multicenter, randomized, placebo-controlled, double-blind trial in approximately 230 patients in Europe and the U.S. with moderate COVID-19.
If clinical activity of IMU-838 is confirmed by the Independent Data Monitoring Committee after the first interim analysis—set to occur after approximately 200 patients have completed the blinded treatment period—the Committee could recommend a confirmatory Phase III trial, Immunic said.
In April, New York-based Immunic said IMU-838 successfully showed preclinical activity against SARS-CoV-2 by inhibiting replication of clinical isolates of the virus. The company cited cellular assays demonstrating antiviral activity at concentrations which were well below the blood concentrations associated with IMU-838 dosing regimens studied in ongoing and previous clinical trials.
As a result, Immunic said, it will prepare a clinical development program for IMU-838 as a treatment for COVID-19 and potential other future viral pandemics. The company said it intends to launch a prospective, multicenter, randomized, placebo-controlled, double-blind Phase II clinical trial assessing IMU-838’s efficacy, safety and tolerability in patients with moderate COVID-19 disease and clinical symptoms.
IMU-838 is under study in ongoing Phase II trials in patients with relapsing-remitting multiple sclerosis, ulcerative colitis, and primary sclerosing cholangitis. The drug has shown antiviral activity in vitro against HIV, hepatitis C virus, human cytomegalovirus, Arenavirus, and Influenza A virus, Immunic said.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: