Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus (SARS-COV-2). The rapid spread of the disease has resulted in a pandemic with millions of confirmed cases and hundreds of thousands of deaths worldwide. While most cases result in mild symptoms, including fever, cough and shortness of breath, severe cases progress into acute respiratory distress syndrome (ARDS) and multi-organ failure, potentially as a result of severe immune overreaction (cytokine storm), or as a result of ischemic injury or other complications. Patients can experience a rapid increase of inflammation-inducing chemical signaling molecules that trigger acute injuries in multiple organs including the liver, kidney and heart.
We are working with FDA on the design of a double-blind, multi-center, placebo-controlled, proof-of-concept Phase 2 study to evaluate the safety and efficacy of DUR-928 in approximately 80 COVID-19 patients with acute liver or kidney injury.
DUR-928 has demonstrated, both in vitro and in vivo, its ability to stabilize mitochondria, modulate inflammatory responses, and promote cell survival and tissue regeneration. In addition, positive results from a Phase 2a study in alcoholic hepatitis (AH) patients showed that all 19 patients dosed with DUR-928 survived the 28-day study, while the historical 28-day mortality rate in AH patients is 26% on average. All together, these data demonstrate the potential of DUR-928 as an effective therapy to prevent or treat acute organ injury in COVID-19 patients.
Several studies have reported that up to 50% of hospitalized patients with COVID-19 had elevated enzyme levels that signal liver injury and more than 33% of hospitalized patients had kidney damage. Acute liver or kidney injury is a risk factor for poor outcomes in COVID-19 patients. These patients are being excluded from many ongoing anti-viral COVID-19 trials and are in great need of a new therapy.
DURECT currently holds the worldwide development and commercialization rights to DUR-928 and other molecules identified as part of the Epigenetic Regulator Program.