The randomised, double-blind, placebo-controlled miR-AGE study investigates the effect of early treatment in 1,034 elderly or high-risk Covid-19 patients. Credit: Governor Tom Wolf.

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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.