French biotech company Abivax has treated the first patient in a phase 2b/3 study of its experimental anti-inflammatory drug ABX464 in COVID-19 patients.
The study, which is being conducted at the University Hospital Center in Nice, France, is investigating the effect of early treatment with ABX464 in 1,034 elderly or high-risk patients with confirmed COVID-19.
Abivax’s main goal is to measure the potential of the experimental treatment to limit viral replication as well as decrease the severe inflammation that leads to acute respiratory distress syndrome (ARDS) in COVID-19 patients.
ABX464 has previously demonstrated efficacy in a phase 2a trial in the severe inflammatory disease ulcerative colitis (UC), in which the drug produced potent anti-inflammatory effects and tissue healing.
The drug’s efficacy in UC patients coupled with its ‘unique molecular mechanism of action’ supports Abivax’s theory that the drug can help to treat cytokine storm and hyper-inflammation syndrome observed in COVID-19 patients.
“ABX464’s unique triple mode of action could potentially limit the replication of SARS-CoV-2 virus, prevent and treat the cytokine storm or hyper-inflammation – and the ensuing acute respiratory failure syndrome – as well as limit long-term lung injury through tissue repair,” said Eric Cua, an infectiologist at the University Hospital Center (CHU) of Nice.
“Due to ABX464’s easy, once-daily oral administration, we can include hospitalised as well as non-hospitalised COVID-19 patients in this trial,” he added.
Currently, Abivax has received approval for studies in France and Germany, as well as in the UK, Italy and Brazil. It also plans to obtain further authorisations in Spain and additional Latin American countries with high infection rates.
A number of pharma companies have been evaluating the efficacy of anti-inflammatory treatments in COVID-19, after overactive inflammatory responses were observed in the lungs of critically and severely ill patients.
That includes Sanofi’s Kevzara (sarilumab) and Roche’s Actemra (tocilizumab), both IL-6 inhibitors that had been theorised to help treat COVID-19.
However, both drugs have recently produced somewhat disappointing results, with Roche’s Actemra failing to help early-stage COVID-19 pneumonia in an Italian study in June, and Sanofi’s drug demonstrating ‘negative trends’ in the severe arm of a phase 2 trial of COVID-19 patients in April.
Despite these results, there is still a focus on the use of anti-inflammatories as a treatment for COVID-19, with Gilead planning combination studies of its anti-viral drug remdesivir with Eli Lilly’s JAK inhibitor Olumiant (baricitinib) and Actemra.