Roivant pushing gimsilumab testing for ARDS in COVID-19 patients

Switzerland-incorporated Roivant Sciences says it is engaged with regulators in the USA, Europe, and Asia to rapidly advance the clinical development of gimsilumab for the treatment of acute respiratory distress syndrome (ARDS) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

A Phase I study of gimsilumab conducted by Roivant completed dosing last month following extensive non-clinical research; gimsilumab treatment has been associated with a favorable safety and tolerability profile to date.

Roivant will prioritize trials of gimsilumab in patients with COVID-19 instead of a Phase II 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.

“Up-regulation of GM-CSF appears to characterize progression to ARDS and death in COVID-19,” said Dr Elizabeth Volkmann, founder and co-director of the UCLA Connective Tissue Disease-Related Interstitial Lung Disease Program. “Targeting GM-CSF represents a promising strategy for curbing lung damage while allowing time for the virus to clear. It is my hope that gimsilumab will reduce mortality from COVID-19 and help improve the lives of those affected by this emerging public health crisis,” she noted.