Arch Biopartners announced the U.S. Food and Drug Administration (FDA) has granted permission to the Company to proceed with a Phase II trial in the U.S. for its lead drug Metablok (LSALT peptide) to prevent acute lung and kidney injury experienced by patients with COVID-19.

The decision by the FDA to authorize the initiation of the Phase II trial came following the Company’s submission of an Investigational New Drug application to the FDA late last week. 

The Phase II trial, which was cleared recently by Health Canada to proceed, will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in sixty patients infected with SARS-CoV-2 (COVID-19). The Company expects to begin the Phase II trial before the end of the summer, 2020.

COVID-19 is the disease caused by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019. Patients with severe COVID-19 develop progressive lung inflammation and acute respiratory distress syndrome that often requires mechanical ventilation and critical care. Patients with severe COVID-19 also experience multiple organ dysfunction including acute kidney injury, liver dysfunction, cardiac failure, and blood abnormalities. Currently, no approved vaccine or effective antiviral drug exists for SARS-CoV-2. Treatment of severe COVID-19 has been primarily supportive, relying heavily on respiratory, infectious disease and critical care medicine.

Survival rates and health care system capacity could both be improved with new treatments that prevent the severe manifestations of COVID-19, such as worsening lung inflammation (ARDS) and AKI experienced by patients infected with SARS-CoV-2.