Leading BioSciences, a drug development company, has developed a potential approach to treat COVID-19 patients with acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS) using its investigational drug LB1148.

Studies in the New England Journal of Medicine report 70% of critically ill COVID-19 patients experienced a shock/hypotension. A case fatality rate of 49% or higher is reported for COVID-19 patients who develop respiratory failure, septic shock, or MODS. Most forms of shock, including septic shock, feature disruption of the gastrointestinal (GI) mucosal barrier, leading to the escape of powerful digestive enzymes that accelerate dangerous inflammation, cytokine storm, autodigestion and organ failure.

Currently under development to treat organ dysfunction and reverse lethal complications associated with septic shock and major surgery, LB1148 is an investigational oral liquid formulation of the protease inhibitor tranexamic acid, designed to inhibit digestive enzyme activity and preserve gut integrity during intestinal distress (shock, infections, surgeries, etc.). In clinical studies, LB1148 has demonstrated safety and improved GI function following major surgery. The active ingredient also has a good safety profile with more than 40,000 patients treated in clinical trials.

The company believes its mechanism of action may limit the viral load in patients with COVID-19 as the SARS-CoV-2 virus uses the ACE2 receptor, which is highly expressed in the lung and GI tract to infect epithelial cells of these organs. Recent research has shown that protease inhibitors may block the enzymatic activity required for COVID-19 infection through the ACE2 receptor.