Setanaxib, a NOX1&4 inhibitor, is the Company's most advanced product in development. Its pharmacodynamic activity and clinical safety profile support the development of setanaxib in many fibrotic diseases.
Setanaxib demonstrated clinical evidence of anti-fibrotic activity in liver fibrosis patients in a Phase II clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease). In this study, in a pre-defined patient population with an estimated liver fibrosis stage of F3 or higher, setanaxib achieved a 22% reduction in liver stiffness compared to a 4% increase for placebo (p=0.038). These data provide a clinical proof of concept for setanaxib and highlight its potential as an anti-fibrotic therapy in the liver and other organs.
This compound is also being evaluated in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD). This trial is led in Australia by world-renowned diabetes experts Professor Mark Cooper, Head of the Department of Diabetes at Monash University, and Professor Jonathan Shaw, Deputy Director (Clinical and Population Health) at the Baker Heart and Diabetes Institute in Melbourne.
A grant from the United States National Institutes of Health (NIH) of $8.9 million was awarded to Professor Victor Thannickal at the University of Alabama at Birmingham (UAB) to fund a multi-year research program evaluating the role of NOX enzymes in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs. The core component of this program will be to conduct a Phase 2 trial with the setanaxib in patients with IPF.