DURECT is committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and lifesaving therapies based on its endogenous epigenetic regulator program. The company’s lead candidate, larsucosterol (DUR-928), is the first endogenous epigenetic regulator clinically tested for difficult-to-treat diseases. Larsucosterol has been shown to modulate the expression of genes associated with cell death, stress response, and lipid biosynthesis. These modulations may lead to improved cell survival, and reduced lipid accumulation and inflammation, as it has been observed in various in vivo animal models and in results from DURECT’s completed clinical trials.

Larsucosterol has demonstrated promising efficacy and safety profiles as a potential treatment for patients with alcohol-associated hepatitis (AH), a life-threatening acute alcoholic liver disease with no approved drugs and an average 28-day overall mortality rate of 26% or 90-day mortality rate of 29%. Larsucosterol is currently being studied in a Phase 2b trial, AHFIRM, and has the potential to become the first drug indicated for the treatment of AH patients. Larsucosterol is also being explored as a potential therapy for patients with nonalcoholic steatohepatitis (NASH).

In addition, we licensed exclusive U.S. commercialization rights to POSIMIR® (bupivacaine solution) to Innocoll Pharmaceuticals who plan to launch in the U.S. in Q2 2022. Under the terms of the agreement, DURECT is entitled to receive up to $136 million in upfront and milestone payments as well as low to mid double-digit royalties on net sales of POSIMIR.

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