There are currently no FDA-approved therapies for NASH. Many investigational treatments aim to reduce inflammation and fibrosis, but have demonstrated little improvement in addressing the underlying metabolic drivers of the disease. In addition, some investigational treatments do not improve dyslipidemia—including hypercholesterolemia and hypertriglyceridemia—which underlies NASH patients’ susceptibility to cardiovascular disease.
We believe our Phase 2 clinical-stage candidate, AKR-001, is a powerful new therapy that has the potential to reverse the underlying metabolic dysregulation of the liver, protect against hepatocyte stress, and suppress downstream inflammation and fibrosis, with the ultimate goal of resolving NASH and restoring a healthy liver.
We recently announced key results from our ongoing Phase 2a trial, the BALANCED study. Specifically, we reported that, after 12 weeks of treatment, patients in each of the three groups treated with AKR-001 had statistically significant reductions in liver fat and a liver enzyme called ALT, compared to placebo. The results observed for the top two dose groups are among the most robust results publicly reported across NASH trials.