Parisian biotech Abivax has received French regulatory approval to proceed with a Phase IIb/III study of its investigational drug ABX464 to treat acute respiratory distress syndrome (ARDS) associated with Covid-19. The so-called mirAGE trial will be carried out in France and other countries in Europe.

ABX464 was originally developed to treat inflammatory disease ulcerative colitis, which led the company to believe it could effective against the deadly cytokine storm associated with Covid-19. In vitro data has shown that ABX464 also inhibits the replication of SARS-CoV-2, the virus which causes Covid-19, meaning it has a second potential mechanism of action to fight this pandemic.

Abivax CEO Professor Hartmut Ehrlich commented: “ Unfortunately, no prophylactic or therapeutic treatment has shown much efficacy in any rigorous trial to treat the severe form of COVID-19; helping clinicians prevent respiratory distress and death in COVID-19 patients and limit longer-term pulmonary damage is of paramount necessity. In addition, relieving hospital intensive care units of the tremendous burden that is being placed upon them is a top priority.

“ABX464 is an orally available small molecule that may have the potential to achieve some of these goals because of its unique mechanism and its ease of use.

“If the miR-AGE trial is successful, we will work with regulatory authorities to make ABX464 available as rapidly as possible.

“ABX464 already has demonstrated that it was safe in clinical trials to treat other inflammatory diseases. We already have ABX464 capsules in stock to treat approximately 50,000 patients and could scale-up ABX464 manufacturing for over one million patients within months.”

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Abivax emphasised its commitment to continuing its development of ABX464 for UC despite the ongoing pandemic.