Roivant Sciences, a company focused on rapidly developing innovative medicines through a novel form of industrial organisation in R&D, has engaged with regulators in the United States, Europe, and Asia to advance the clinical development of Gimsilumab, intended for the treatment of acute respiratory distress syndrome (ARDS) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, it was reported on Wednesday.

The product is a clinical-stage, fully human monoclonal antibody targeting granulocyte-macrophage colony stimulating factor.

Gimsilumab has been tested in various non-clinical studies and two clinical studies, including a four-week Phase one study of a subcutaneous formulation in healthy volunteers conducted by the company, which completed dosing last month. Roivant says that it has demonstrated a favourable safety and tolerability profile based on data collected to date, with no serious adverse events reported.

Roivant will prioritise trials of gimsilumab in patients with COVID-19 instead of a Phase 2 trial in a separate disease area which had been previously planned. Clinical trials of gimsilumab in patients with COVID-19 will commence upon approval by relevant regulatory authorities.