Exciting news is on the horizon for patients suffering from Primary Biliary Cirrhosis with the recent announcement of a potential new treatment- Obeticholic Acid. Phase 3 study results were extremely encouraging regarding this novel farnesoid X receptor, which acts as a regulator of the nuclear bile acid receptor. Obeticholic Acid has proven in clinical trials to help regulate bile acid homeostasis, heal intestinal and hepatic inflammation, and reduce liver fibrosis in patients with the rare liver disease Primary Biliary Cirrhosis, also known as PBC. Over two decades have passed with no new treatments for this virulent disease, which mainly affects one of every one thousand women over the age of forty.
The only medication currently approved to treat PBC, Ursodeoxycholic Acid is ineffective in almost fifty percent of patients, as half of the people with this uncommon liver disease do not demonstrate an adequate response to the drug. Research and development teams are hopeful that the unique ability of Obeticholic Acid as a selective farnesoid X receptor agonist will continue to elicit a positive response in patients even after clinical trials have concluded.
Results from Phase 3 studies of Obeticholic Acid have revealed that this drug sizably reduces levels of alkaline phosphatase in almost half of all patients, compared to only ten percent of patients who were administered a placebo. Additionally, a tangible impact of Obeticholic Acid was seen in clinical trial participants as early as two weeks after administration of this medication, with a peak efficacy noted in patients at the six month mark of treatment. Obeticholic Acid proved for the majority of patients to be safe and tolerable, with an adverse effect of pruritus, or severe itching being the main issue. However, even with the risk of possible pruritus the benefits of Obeticholic Acid are abundantly clear. Over 500 patients have received this treatment for PBC and Intercept Pharmaceuticals, the makers of Obeticholic Acid are touting this formidable drug to be extremely effectual. Results from a trial coined POISE was recently presented by Intercept at the 2014 European Association for the Study of the Liver International Liver Congress. Dosages of Obeticholic Acid in clinical trials were either 5 milligrams daily or 10 milligrams once a day.
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