Arch Biopartners has engaged a global contract research organization to initiate and conduct a Phase II trial in the U.S. for its lead drug Metablok (LSALT peptide) to treat complications in patients with COVID-19 including the prevention of acute lung and/or kidney injury.
The Phase II trial 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).
Following guidance and discussion with the FDA during the review of the Phase II protocol, the primary endpoint of the trial was expanded to a composite that includes prevention of ARDS and AKI. The composite reflects severe effects often experienced by hospitalized COVID-19 patients and deemed appropriate for LSALT peptide’s novel mechanism of action in blocking consequential inflammation in these organs.
“We have focused our efforts to conduct the Phase II trial in the U.S., where there has been a significant increase in COVID-19 infections. We look forward to working with our new CRO and U.S. hospital sites as we try to increase survival rates of hospitalized COVID-19 patients at risk of lung and kidney inflammation,” said Richard Muruve, CEO of Arch.