California-based specialty drug manufacturer Durect Corporation (NASDAQ:DRRX) announced positive topline results from its phase 1B clinical study of DUR-928 for the treatment of nonalcoholic steatohepatitis (NASH). The results demonstrated improvement in both liver enzyme levels and liver imaging as well as an improved serum lipid profile. The drug was well tolerated by patients in the study with no adverse side effects.

NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD), is commonly associated with obesity and diabetes. Symptoms of the disease are often silent or non-specific to NASH which makes it challenging to diagnose.

The oral DUR-928 therapy was given to 65 patients with stage 1 to 3 fibrosis for a period of four weeks at 50mg, 150mg, and 600mg doses. On day 28 of the study, the 50mg and 600mg patient cohorts showed a statistically significant median reduction of alanine aminotransferase (ALT) levels of -16% and -17% respectively. Patients in the 600mg dose group also showed an 18% median reduction of aspartate aminotransferase (AST) and an 8% reduction in gamma-glutamyl transferase (GGT). Meanwhile, the 50mg dose group had a 10% reduction in liver stiffness as measured by specialized liver ultrasound machine Fibroscan. Liver fat reduction of at least 10% was seen in 43% of patients across all three cohorts.

Durect SEC Filings

DUR-928 also being considered as organ damage treatment in COVID-19 patients

The drug, which is also being evaluated as a treatment for alcoholic hepatitis (AH), was recently noted for its potential benefit in COVID-19 patients. Durect is working with the U.S. Food and Drug Administration (FDA) to develop plans for a phase 2 clinical trail to test DUR-928 as a possible treatment for COVID-19 patients with acute liver or kidney injury. The drug is not intended to battle the coronavirus, but rather to help with organ damage that is often caused by the infection. The company has estimated that as many as half of COVID-19 patients display signs of liver damage and approximately one-third have kidney damage.

CEO Dr. James E. Brown stated, “It is impressive to see these improvements after such a short treatment period. Multiple important liver enzymes, plasma lipids and imaging results moving in the same direction is a very promising indication of DUR-928’s potential in NASH.”

Durect develops treatments for a range of chronic diseases and conditions by combining the industry’s engineering innovations and drug delivery technology with its proprietary pharmaceutical and biotechnology drug formulations. Its primary focus is the treatment of acute organ injury and chronic liver diseases using its endogenous epigenetic regulator program.

Looking ahead

The encouraging DUR-928 efficacy and safety data represents another step forward in the development of Durect’s novel NASH treatment. The results contrasted with a recent report from competitor Genfit which showed disappointing trial results in the development of elafibranor, a potential rival drug candidate for the treatment of NASH.

Durect is planning on presenting additional results and analyses at an upcoming scientific meeting. While DUR-928 is the company’s primary value driver, its pipeline also includes a drug delivery program for Posimir, a non-opioid post-operative pain treatment that is under review by the FDA.

Shares of Durect were up more than 10% in midday trading on May 26th. The small cap stock has climbed nearly 200% over the last 12 months.

Durect SEC Filings


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