Altasciences has completed a Phase I study for gimsilumab, a fully human monoclonal antibody that targets granulocyte-macrophage colony stimulating factor (GM-CSF), found to be up-regulated in SARS CoV-2 in patients with or at risk of developing acute respiratory distress syndrome (ARDS).

Roivant Sciences has said they will prioritize gimsilumab trials 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 patients with COVID-19 will start after relevant regulatory approvals. Gimsilumab treatment has been associated with a favorable safety and tolerability profile to date.

Emerging clinical evidence in COVID-19 patients suggests that GM-CSF contributes to immunopathology caused by SARS CoV-2 in patients with or at risk of developing ARDS. ARDS is a serious complication of COVID-19 which requires hospitalization and mechanical ventilation or other life support measures.

“We are proud to have collaborated with Roivant Sciences on this important development, which may help ease the suffering of patients afflicted by COVID-19, as well as other ARDS patients in need of therapy” said Ingrid Holmes, Vice President, Global Clinical Operations at Altasciences.  

Altasciences is a mid-size CRO offering pharma and biopharma companies preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.