Partner Therapeutics (PTx) has announced the initiation of the iLeukPulm Phase 2 trial of an inhaled formulation of its Leukine sargramostim in hospitalized COVID-19 patients in respiratory distress. Partner recently signed a $35 million contract with the US Department of Defense for development of Leukine for the treatment of COVID-19.
PTx acquired Leukine, a granulocyte-macrophage colony stimulating factor (GM-CSF), from Sanofi in 2018. Leukine is currently approved for treatment of acute myelogenous leukemia and bone marrow transplant. Two studies of sargramostim for the treatment of COVID-19 are already underway: a study of inhaled sargramostim in Belgium, and study of intravenous sargramostim in Singapore.
Principal investigator Robert Paine of the University of Utah commented, “Prior research in patients with acute respiratory distress syndrome has shown that sargramostim administered intravenously is safe and associated with a trend toward a reduction in mortality. These findings provide strong support for clinical research to assess the safety and efficacy of sargramostim in the treatment of COVID-19 infection. I believe that administering sargramostim by inhalation as soon as patients are hospitalized and require oxygen due to COVID-19 could improve time to recovery, facilitate long-term healing of the lung, and reduce the need for invasive procedures such as mechanical ventilation.”
Co-principal investigator Scott Halstead of the Penn State College of Medicine added, “GM-CSF is a naturally occurring protein that is essential for healthy lung function. More specifically, research shows that sargramostim can reduce the risk of secondary infection, accelerate the removal of debris caused by pathogens, and stimulate alveolar epithelial cell healing during lung injury. The iLeukPulm study is an important clinical trial to assess whether inhaled sargramostim can help COVID-19 patients who have progressed to the point of requiring oxygen.”
Read the Partner Therapeutics press release.
