Roivant Sciences is in discussion with the US, Europe and Asian regulators to develop gimsilumab for treating acute respiratory distress syndrome (ARDS) caused by Covid-19.
Gimsilumab is a fully human monoclonal antibody, which targets granulocyte-macrophage colony-stimulating factor (GM-CSF), found to be up-regulated in the serum of Covid-19 patients.
UCLA Connective Tissue Disease-Related Interstitial Lung Disease Program founder and co-director Dr Elizabeth Volkmann said: “Up-regulation of GM-CSF appears to characterise progression to ARDS and death in Covid-19. 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.”
The company will focus on testing gimsilumab in Covid-19 patients rather than a previously planned Phase II trial in another disease area.
Clinical trials of the drug in Covid-19 will be initiated after receiving regulatory approvals.
Mateon’s COVID-19 drug candidate
Mateon Therapeutics is exploring the use of a TGF-Beta antisense drug candidate OT-101, currently in Phase III development, for treating COVID-19 infection.
In an in vitro antiviral testing by an independent laboratory, the drug candidate showed an 50% effective concentration (EC50) of 7.6µg/mL and non-toxicity at the highest dose of 1000µg/mL.
The company intends to seek clearance from the US Food and Drug Administration (FDA) for OT-101 to be tested clinically against Covid-19, following the completion of preclinical tests.
OT-101 is being developed as an anti-cancer drug, with Phase III trials planned for glioma and pancreatic cancer patients.
Earlier this month, Mateon launched an antiviral response programme with initial focus on Covid-19.
The company also plans to use its AI Vision technology to monitor existing Covid-19 patients, or those infected by any future viruses.