The first patient has been treated in Abivax’s Phase IIa/III study of ABX464 in COVID-19 patients at the University Hospital Centre in Nice, France.
The randomised, double-blind, placebo-controlled miR-AGE study investigates the effect of early treatment (at point of diagnosis) in 1,034 COVID-19 elderly or high-risk patients. The main goal of the trial is to measure the potential of ABX464 to limit viral replication as well as the severe inflammation that leads to acute respiratory distress syndrome (ARDS).
Abivax has already received clearance for the study from the regulatory authorities in France and Germany as well as in the UK, Italy and Brazil and expects authorisation to follow in Spain and additional Latin American countries with high infection rates, including Mexico, Chile and Peru in due course.
Prof. Hartmut Ehrlich, CEO of Abivax, said: “We are pleased that the first patient in our miR-AGE trial has been treated and that recruitment and treatment at further sites in Europe and Latin America can now proceed swiftly. After the approval of the regulators in Brazil, additional regulatory approvals in Latin American countries, where the epidemic has still not reached its peak, are expected to follow soon. We expect first top-line results from miR-AGE by the end of the year. Enrollment in our other clinical trials is now back on track with more than half (122/232) of the patients randomized in the ulcerative colitis Phase IIb trial and with recruitment in the Phase IIa trial in rheumatoid arthritis and the US Phase I/II trial in hepatocellular carcinoma progressing as well. With non-dilutive funding provided by Bpifrance and Société Générale, Abivax’s projects are fully financed until early 2021 and discussions for further, preferably non-dilutive financial options are ongoing.”