In a recent press release, DURECT Corporation announced initiation of patient recruitment for a phase 2 safety and efficacy study of DUR-928 in COVID-19 patients with acute liver or kidney injury. The primary efficacy end point of the randomized, double-blind, placebo-controlled, multi-center study is a composite of survival and being free of organ failure at day 28. Free of organ failure is defined as free of mechanical ventilation, free of liver failure events, and free of renal replacement therapy. The trial expects to enroll approximately 80 patients.
Patients will receive a dose of 150 mg of DUR-928 or placebo by intravenous infusion on day 1 and day 4 in combination with standard of care therapy, which will be determined by the principal investigator at each clinical trial site. Follow-up will continue for 60 days. If, during the trial period, the US FDA approves any drug product to be safe and effective for the treatment of COVID-19, such treatments may be offered, at the discretion of each principal investigator, to any remaining and future trial participants.
James E. Brown, DVM, president and CEO of DURECT, said, “Unfortunately, acute liver or kidney injury is associated with a significantly increased risk of death in hospitalized COVID-19 patients. Multi-organ failure is the cause of death in many critically ill COVID-19 patients just as it is in severe alcoholic hepatitis (AH), a life-threatening disease with a 28-day mortality rate of 26%. Based on positive clinical results of DUR-928 in AH patients from our phase 2a trial, and our preclinical data in multi-organ failure models, we believe that DUR-928, in combination with standard of care, has the potential to help COVID-19 patients with acute liver or kidney injury. There is a great need to explore life-saving treatment options for these high risk patients.”