AB Science has dosed the first subject in its Phase II trial, which will assess the antiviral activity of masitinib in Covid-19 patients.
The latest move comes after the company received approval from the South African and Russian Regulatory Authorities to begin the study, in September.
An orally administered tyrosine kinase inhibitor, masitinib targets mast cells and macrophages, mainly cells for immunity.
The double-blind, randomised, placebo-controlled Phase II clinical trial will assess the efficacy of masitinib in symptomatic mild to moderate patients diagnosed with Covid-19.
It will evaluate the therapy’s antiviral efficacy by administering it at three different dosages.
The clinical study will enrol 78 non-hospitalised patients with mild disease or those hospitalised with Covid-19 without the need for non-invasive ventilation.
AB Science co-founder and CEO Alain Moussy said: “The new Omicron variant reminds us that the SARS-CoV-2 virus is rapidly evolving with the selection and accumulation of mutations, mainly in the Spike protein, and that these mutations may lead to increased transmissibility of the virus and potential evasion of some vaccines.
“Evidently, there is a continued need for effective antiviral treatments that are insensitive to these variants.”
The trial’s primary efficacy goal will be to demonstrate that the therapy can reduce the SARS-CoV-2 viral load faster compared to a placebo control group, which will be given best supportive care (BSC).
Moussy added: “We are committed to continuing the clinical development of masitinib in Covid-19 because this pandemic is clearly not over yet.
“Moreover, masitinib appears to be a unique drug in the anti-Covid arsenal, having potential therapeutic activity across all of its stages by merit of its dual antiviral/anti-inflammatory mechanism of action.”