SARPAC Clinical Trial of Leukine (sargramostim, rhu GM-CSF) in Hospitalized COVID-19 Patients Meets Primary Endpoint of Significant Improvement in Lung Function

On Mar 1, 2021

Partner Therapeutics, Inc. (PTx) announced top-line results of the investigator-led SARPAC (Sargramostim in Patients with Acute Hypoxic Respiratory Failure and Acute COVID-19) study of inhaled Leukine (sargramostim, yeast-derived recombinant human GM-CSF) in hospitalized COVID-19 patients (NCT04326920). This prospective, randomized, open-label study was led by University Hospital Ghent and conducted at five hospitals in Belgium. The study enrolled 81 patients with PCR-confirmed COVID-19 who were suffering from acute hypoxic respiratory failure requiring supplemental oxygen. The full study and translational results are being prepared for publication.

Lung dysfunction resulting in hypoxemia has been a hallmark of severe cases of COVID-19. SARPAC was launched based on GM-CSF’s role in restoring alveolar macrophages that have anti-inflammatory properties and serve to remove pathogens and other debris while maintaining alveolar surfactant. This hypothesis has been the basis for prior studies of sargramostim in Acute Respiratory Distress Syndrome (ARDS). SARPAC was conducted using inhaled sargramostim to target the lungs. Sargramostim is not approved by U.S. Food and Drug Administration (FDA) for use in COVID-19 or for inhaled administration.

“The results from SARPAC represent a major advance for patients with acute hypoxic respiratory failure due to COVID-19 and validate sargramostim’s critical role in the repair and healthy functioning of the lung,” said Bart Lambrecht, MD, PhD, Professor of Pulmonary Medicine at The University Hospital Ghent, and Scientific Director of the Center for Inflammation Research at the Flanders Institute of Biotechnology (VIB) in Belgium, and principal investigator of the study. “The study confirms sargramostim’s role in restoring the oxygen uptake function of the lung, while at the same time stimulating specific immune cells that fight against the virus.”