An on-going study of an investigational drug for primary biliary cholangitis has been given the go-ahead to continue by a safety monitoring board. The planned review recommended that the Phase 2 study continues without changing the study protocol. For more detailed information about this, you can read the source news release here, at Business Wire.
About Primary Biliary Cholangitis
Primary biliary cholangitis (PBC), often called primary biliary cirrhosis, is a type of liver disease that may get worse over time, and, in some cases, can lead to liver failure. Some people with PBC don’t experience symptoms, whereas others may develop aches, fatigue, and itchiness, amongst other possible signs. PBC is caused by the body’s immune system mistakenly attacking bile ducts and damaging them, resulting in a build-up of bile in the liver. To find out more about PBC, click here.
A Phase 2 clinical trial is investigating the drug GKT831 for its potential use as a treatment for PBC. It is a 24-week double-blind study that will compare the effects of the drug to those of a placebo in approximately one hundred patients with PBC. All the patients who take part are given UDCA (ursodeoxycholic acid), which is a treatment for PBC, and then, depending on which of the three groups they are in, either a placebo, or GKT831 once per day, or GKT831 twice per day. For patients who complete the study, there are plans to begin an open-label extension study (if the safety data continues to be favourable), which would allow them to continue treatment with GKT831.
Genkyotex, the company holding the study, has announced updates about the trial. According to their press release, a planned data review by an independent safety monitoring board has taken place. The board has recommended that the study continues without amending its protocol. This decision was based on data collected from 77 patients, 60 of who had undergone at least six weeks of treatment. Genkyotex also says that they expect interim data about the efficacy of the drug to be available in Fall 2018, and the final study results to be released in the first half of 2019.