The company Genkyotex has announced that they have finished enrolling participants for a Phase 2 clinical trial of the investigational drug GKT831 in patients who have primary biliary cholangitis. The study has enrolled 111 patients; nine more than their original target. For more detailed information you can view the source press release at Business Wire by clicking here.
About Primary Biliary Cholangitis (PBC)
PBC, also known as primary biliary cirrhosis, is a form of liver disease that can progress over time, and, in some cases, may lead to liver failure. PBC is caused by the body mistakenly attacking bile ducts. Bile ducts are involved in carrying bile, a liquid that helps to digest fats and remove waste. Over time, attacks to the bile ducts can damage them and cause bile to accumulate in the liver, which may cause further damage and scarring.
Genkyotex is investigating a potential therapy for PBC called GKT831 in a Phase 2 clinical trial. The study is planned to take place over twenty-four weeks and will compare the effects of GKT831 to those of a placebo in 111 patients with PBC who have had an inadequate response to UDCA (ursodeoxycholic acid). The participants will be divided into three groups, all of which will receive UCDA; one group will also receive a placebo, another will be given 400mg of GKT831 once per day, and the third group will receive 400mg of GKT831 twice per day. Genkyotex says that they expect to have interim results in November, and for the final results to be released in Spring of next year.
GKT831 is an investigational drug that is believed to have anti-inflammatory and anti-fibrotic properties. This drug works by inhibiting the enzymes NOX 1 and 4 to affect fibrogenic pathways. In addition to research into GKT831 as a potential therapy for PBC, the drug is also being studied in Phase 2 trials involving patients with liver fibrosis and kidney fibrosis. The US National Institutes of Health has also awarded a grant to support a study of GKT931 for patients diagnosed with idiopathic pulmonary fibrosis.