Clinical Trial Shows Itolizumab Reduces Mortality in Patients Hospitalized with COVID-19 - Seite 2

“As the entire world grapples with the ongoing COVID-19 pandemic it is critical to identify new treatments that improve outcomes for the sickest patients, and these reported early clinical data suggest that itolizumab holds promise,” said Siddhartha Mukherjee, M.D., Ph.D., a clinical advisor to Equillium and Biocon, Pulitzer Prize Award-winning author, and an Associate Professor of Medicine at Columbia University’s Herbert Irving Comprehensive Cancer Center.

Ivor S. Douglas, M.D., FRCP (UK) Professor of Medicine, Chief of Pulmonary and Critical Care and Medical Director, Medical Intensive Care Denver Health Medical Center, added, “Patients with COVID-19 experience acute respiratory failure caused by the immune system flooding the bloodstream with inflammatory proteins, which can kill tissue, damage organs and pathologically activate clotting cascades in the lungs, heart, and kidneys. The novel mechanism of itolizumab, which works by inhibiting CD6 to reduce the activation and trafficking of pathogenic T cells that release pro-inflammatory cytokines, may be well suited to address SARS-CoV-2 induced inflammation that drives respiratory failure in patients with COVID-19. The preliminary data as reported by Biocon is encouraging and highlights the urgent importance of further evaluating the potential therapeutic efficacy of itolizumab in treating patients diagnosed with COVID-19.”

Itolizumab is a first-in-class immune-modulating antibody therapeutic with a novel mechanism of action that inhibits the activity and trafficking of pathogenic T cells that release pro-inflammatory cytokines in a range of autoimmune and inflammatory diseases. Equillium acquired rights to develop and commercialize itolizumab in the U.S., Canada, Australia and New Zealand through an exclusive collaboration and license agreement with Biocon. Equillium is currently evaluating itolizumab under two open U.S. INDs for the treatment of acute graft-versus-host disease and lupus nephritis, as well as conducting a clinical study in uncontrolled asthma in Australia and New Zealand.

Biocon previously developed and received approval of Itolizumab for the treatment of plaque psoriasis in India, demonstrating the product was safe and well tolerated. Biocon manufactures itolizumab at commercial scale at its cGMP bio-manufacturing facility that is regulated by the U.S. Food & Drug Administration.

In March of this year, as a result of the emerging COVID-19 pandemic, Equillium announced that it was pausing enrollment in the EQUIP trial for uncontrolled asthma and the EQUALISE trial for lupus nephritis. Today Equillium announces that patient enrollment in both of these studies has resumed.