Linerixibat (GSK2330672) granted Orphan Status

Linerixibat (GSK2330672) granted Orphan Status

Linerixibat (GSK2330672), a drug that is being developed for PBC patients who experience itchiness, has recently been granted “orphan” status by the FDA.  This is wonderful news for patients who are suffering from itchiness (pruritus) which is one of the main symptoms of Primary Biliary Cholangitis. 

Orphan status is a special designation given by the FDA for drugs that target rare diseases.  With orphan status companies are encouraged to develop treatments for a rare diseases. Rare disease patients benefit from orphan status as the drug development process is shortened and treatments become available sooner.

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Itch is common in people with PBC.  Currently available treatments are not always effective and may have side effects. In PBC, the bile ducts in the liver become damaged which causes the build-up of bile acid salts in the body.   This may cause some patients to experience persistent itching (pruritus).
The drug being developed by GSK is currently called GSK2330672.  Itis being developed as a tablet to treat the PBC itch. Bile passes from the liver into the intestines where it helps with the digestion of food. Some of the bile is then taken back up into the blood and returned to the liver. GSK2330672 blocks the uptake of bile from the intestines. It is anticipated that this will allow the chemicals that cause the itch to be lost from the body in a person’s stool.

How to get involved in the study
GSK2330672 has already been tested in PBC patients in a small study. This larger study aims to find out which dose and dose frequency improves itch and if it has an effect on the underlying PBC disease. The study will test a range of doses to compare the effect, safety and how well it is tolerated by patients with moderate to severe itch due to PBC.
In Canada, the study is based in 5 research centres in Montreal, Winnipeg, Calgary, Edmonton and London. The study involves 7 visits at the study site and 1 final telephone contact with the study doctor or nurse. Patients participating in this study will receive reimbursement of their travel expenses and compensation for meals and refreshments for 2 of the visits which are expected to last between 2 and 5 hours.

Current Status

GSK2330672 is currently being evaluated in a Phase 2b study. When the study is completed at all the study sites, the data will be analyzed.  Read more about this study here.