"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 AH, a life-threatening disease with a 28-day mortality rate of 26%. Based on the 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," stated
About the Phase 2 Trial
This Phase 2, randomized, double-blind, placebo-controlled, multi-center study is designed to evaluate safety and efficacy of DUR-928 in COVID-19 patients with acute liver or kidney injury. The primary efficacy endpoint is a composite of being alive and free of acute organ failure (free of mechanical ventilation, free of liver failure events and free of renal replacement therapy) at day 28.
A total of approximately 80 patients will be enrolled into two study treatment groups in a 3:1 (DUR-928:placebo) ratio. 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 (PI) at each clinical trial site.
Patients will be followed for 60 days. Should any drug product be determined by the FDA to be safe and effective for the treatment of COVID-19 during the trial, such treatments may be offered, at each PI's discretion, to any remaining and future patients in this trial.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus (SARS-COV-2) infection. The rapid spread of the disease has resulted in a pandemic with millions of confirmed cases and causing hundreds of thousands of deaths worldwide. While most cases result in mild symptoms, including fever, cough and shortness of breath, some rapidly progress into Acute Respiratory Distress Syndrome (ARDS), multi-organ failure, and death. Many of these patients experience a rapid elevation of inflammation-inducing signaling molecules (cytokine storm) that trigger acute injuries in multiple organs including the liver and the kidney. Organ injury may also occur in hospitalized COVID-19 patients as the result of other complications of the viral infection. In a study of 1,059 adult cases of confirmed COVID-19, 62% of patients presented with at least one elevated liver enzyme. In another study, 36.6% of 5,449 patients admitted with COVID-19 had or developed AKI.
DUR–928 is a first-in-class, small molecule, new chemical entity and an endogenous epigenetic regulator. It is in Phase 1 and Phase 2 development for three indications and is the lead candidate in
DURECT Forward-Looking Statement
The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not replicate the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in
NOTE: POSIMIR® and SABER® are trademarks of
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Mike Arenberg, DURECT, Chief Financial Officer, +1-408-346-1052, firstname.lastname@example.org; Media, Alison Chen, LifeSci Communications, +1-646-876-4932, email@example.com