Athersys has received US Food and Drug Administration (FDA) approval to conduct a Phase II/III clinical trial of MultiStem therapy to treat moderate to severe Covid-19-related severe acute respiratory distress syndrome (ARDS).

The first clinical sites for the MACOVIA trial are set to open this quarter.

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This programme is part of the company’s investigational new drug (IND) application for the completed MUST-ARDS study.

The company recently completed a Phase I/II trial of MultiStem in ARDS patients and the study data supported the fast track designation granted by the FDA to the programme.

The new trial will initially have a multi-centre, open-label lead-in, which will be followed by a double-blinded, randomised, placebo-controlled Phase II/III portion.

MACOVIA’s primary objectives are the safety and efficacy of MultiStem therapy in patients with moderate to severe ARDS caused by Covid-19.

The primary efficacy endpoint will be the number of ventilator-free days to day 28 compared to placebo.

Meanwhile, the secondary objectives of the trial are pulmonary function, all-cause mortality, tolerability, and quality of life (QoL) among survivors.

The study will recruit around 400 patients at pulmonary critical care centres across the US. It also includes a third planned cohort, which will be based on analysis of the second cohort data.

Athersys senior medical director and clinical operations head Dr Eric Jenkins said: “With encouraging non-clinical and clinical data, affirmed by the FDA’s fast track designation for ARDS, Athersys and its collaborating clinical investigators are highly motivated by the FDA’s authorisation that we may proceed with enrollment of the first open-label cohort to evaluate safety.

“We believe that MultiStem treatment, by modulating patients’ hyperinflammatory response to highly pathogenic respiratory viruses, including SARS-CoV-2 which causes Covid-19, represents a very promising approach to improving outcomes in patients who suffer the most severe manifestations of these illnesses.”

The company is in talks with the US Biomedical Advanced Research and Development Authority (BARDA) to accelerate the development of MultiStem for ARDS due to Covid-19 and other potential pandemic outbreaks.