Arch Biopartners has expanded the primary endpoint of the Phase II human trial for its lead drug LSALT peptide (Metablok) to prevent organ inflammation and injury experienced by patients with COVID-19.
The expansion of the primary endpoint reflects recent global data from COVID-19 patients that shows the SARS-CoV-2 virus results in damage to organs besides the lungs and Metablok’s potential to prevent inflammation injury in multiple organs.
In addition to acute respiratory distress syndrome (ARDS), the primary endpoint of the Phase II trial now includes acute kidney injury (AKI), cardiomyopathy, acute liver injury, coagulopathy and all-cause mortality as components of a composite endpoint in hospitalized COVID-19 patients. Studies have shown that COVID-19 results in 35% mortality with AKI1 and 40% mortality with cardiomyopathy2. Further, acute liver injury3 and thrombotic disease4 have resulted in poor outcomes in COVID-19 patients.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
The Phase II trial, which was recently cleared by Health Canada to proceed, will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide. The trial is expected to commence in the summer of 2020.
Arch has recently made progress and continues to be in dialogue with the U.S. Food and Drug Administration to obtain permission to recruit patients at American clinical sites into the trial.