Biotechnology company Abivax has secured approval from France’s National Agency for the Safety of Medicines (ANSM) and French Ethics Committee (CPP) to conduct a Phase IIb/III clinical trial of ABX464 in Covid-19 patients.

The miR-AGE trial will assess the drug candidate for preventing severe inflammation that causes acute respiratory distress syndrome (ARDS) in 1,034 elderly or high-risk patients.

ABX464’s molecular mechanism of action are expected to help treat the cytokine storm and hyper-inflammation syndrome found in Covid-19 patients.

The drug candidate demonstrated ability to upregulate miR-124, a ‘physiological brake’ of inflammation. miR-124 is a micro-RNA that downregulates several chemo- and cytokines related to Covid-19 cytokine storm, including TNF alpha, IL-1 beta, G-CSF, IL-6, MCP-1 and IL-17.

In addition, the candidate was observed to inhibit the replication of SARS-CoV-2 in an in-vitro human pulmonary epithelium model, indicating its triple action as an anti-inflammatory, antiviral, and tissue repair agent.

The Phase IIb/III trial will be conducted at 50 hospitals in France and other European countries. It will compare 50mg once-daily ABX464 to placebo and standard of care in both hospitalised and non-hospitalised patients.

Enrolment is expected to be concluded within a few months. The study will mainly track the absence of high-flow oxygen use or assisted ventilation or death within 28 days.

The trial will also investigate ABX464’s ability to prevent ARDS in elderly patients with or without risk factors, in younger patients with risk factors, along with secondary impacts of Covid-19 on pulmonary function.

Abivax CEO Hartmut Ehrlich said: “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.

“The robust, rigorous design of the miR-AGE ABX464 trial ensures we will draw valid scientific and medical conclusions. If the miR-AGE trial is successful, we will work with regulatory authorities to make ABX464 available as rapidly as possible.”

Abivax has a stock of ABX464 capsules sufficient to treat approximately 50,000 patients and could scale-up manufacturing for more than one million patients within months.