Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today announced that the World Health Organization (WHO) has recommended setanaxib as the international nonproprietary name (INN) for GKT831.
The new stem “naxib” approved by WHO refers to NADPH oxidase inhibitors, and formally establishes a new therapeutic class under the WHO INN system.
The WHO assigns an INN to new pharmaceutical substances or active pharmaceutical ingredients (API). Each INN includes a stem which indicates that a pharmaceutical product belongs to a group of substances having similar pharmacological activity, and a new stem is only recommended when a group of at least several new substances shows a confirmed novel mode of action.
Elias Papatheodorou, CEO of Genkyotex, commented: “As the leader in the development of NOX therapeutics, we are thrilled with the WHO decision to formalize NOX inhibitors as a novel therapeutic class. By recommending the INN setanaxib for GKT831, the most advanced compound in the NOX inhibitor class, the WHO is recognizing its novel mechanism of action.”
NOX inhibitors have a significant therapeutic potential for fibrotic and inflammatory disorders, neurodegenerative diseases, and oncology. Recently, GKT831 has shown clinical evidence of anti-inflammatory and anti-fibrotic activity in patients with fibrotic liver disease in a Phase 2 Primary Biliary Cholangitis (PBC) trial, highlighting its potential as a possible treatment for multiple complex and difficult to treat fibrotic disorders, including non-alcoholic steatohepatitis (NASH), PBC, diabetic kidney disease (DKD), and idiopathic pulmonary fibrosis (IPF).
A second Phase 2 study is ongoing in diabetic patients with kidney fibrosis, and the US Food and Drug Administration (FDA) recently approved the initiation of an additional Phase 2 trial in patients with patients with IPF.