COVID-19 poses a serious global concern for patients and the healthcare system. Studies in the New England Journal of Medicine report 70% of critically ill COVID-19 patients had a shock/hypotension episode. A case fatality rate of 49% is reported for COVID-19 patients who develop respiratory failure, septic shock, or multiple organ dysfunction syndrome (MODS). Prevention of shock-associated organ damage in patients with COVID-19 may improve mortality and morbidity. Most forms of shock, including septic shock, feature damage to the gastrointestinal (GI) mucosal barrier, leading to the escape of active digestive enzymes and subsequent organ/tissue damage.
Leading BioSciences is offering our lead drug, LB1148, as a potential therapy for patients with coronavirus-associated acute respiratory distress syndrome (ARDS) and MODS. LB1148 is under development to support organ health and reverse the potentially lethal complications of organ dysfunction associated with sepsis, shock, and the post-surgical setting. This novel therapeutic has (1) a good safety profile, (2) shown preliminary efficacy in phase 2 clinical studies for surgical indications, (3) open investigational new drug (IND) application with the United States Food and Drug association (FDA) for the treatment of septic shock, vasodilatory shock or critical illness with risk of multiorgan dysfunction syndrome, and (4) a good manufacturing practice (GMP) clinical supply ready to be tested in patients.
LB1148 has demonstrated safety in clinical studies and increased survival in multiple models of shock. We propose LB1148 will preserve the GI mucosal barrier during respiratory dysfunction and halt the progression of the COVID-19 disease to MODS and death.
LB1148 is designed to inhibit digestive enzyme activity and preserve gut integrity during intestinal stress (i.e. shock, cardiovascular events, infections, surgeries). Evidence suggests that digestive enzyme leakage from the GI tract causes the organ dysfunction, morbidity, and mortality associated with shock. When the GI barrier is disrupted, powerful digestive enzymes escape from the intestines, triggering a dangerous cascade of inflammation, cytokine storm, autodigestion of tissues, and organ failure, including ARDS.