French biotechnology company Abivax has dosed the first patient in its Phase II/III study of ABX464 in Covid-19 patients at the University Hospital Center in Nice, France.
This randomised, double-blind, placebo-controlled miR-AGE study investigates the effect of early treatment in 1,034 elderly or high-risk Covid-19 patients.
The trial will evaluate the potential of the drug candidate to limit viral replication and the severe inflammation that leads to acute respiratory distress syndrome (ARDS).
Commenting on the latest development, Abivax CEO Prof.Hartmut Ehrlich 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.”
ABX464’s molecular mechanism of action is expected to treat the cytokine storm and hyper-inflammation syndrome observed in Covid-19 patients.
Abivax received approval for miR-AGE study in France and Germany, Italy, Brazil and the UK. The company plans to obtain further authorisations in Spain and other Latin American countries with high infection rates in due course.
French investment bank Bpifrance is providing the financing for the miR-AGE Phase IIb/III trial along with manufacturing scale-up, additional clinical and other development costs.
Abivax recently received €5m in non-dilutive financing from SociétéGénérale in the form of a loan guaranteed by the French state. The company said its operations and ongoing clinical study programmes are fully financed until next year.