Intercept’s Ocaliva meets primary endpoint in Phase III trial for rare liver disease
pharmafile | August 18, 2016 | News story | Medical Communications, Research and Development | intercept, ocaliva
Intercept Pharmaceuticals have announced the publication of Phase III results published in the New England Journal of Medicine, where Ocaliva (obeticholic acid) met its primary endpoint for patients with rare liver disease, primary biliary cholangitis.
Primary biliary cholangitis (PBC) is a progressive, autoummune cholestatic liver disease that primarily affects women. It is estimated that the debilitating disease affects one in 1,000 women over the age of 40. Bile ducts in the liver become damaged, leading to a build-up and eventually scarring.
In the Phase III POISE trial, Ocaliva improved multiple biochemical disease markers with high statistical significance when compared with placebo. It also successfully achieved its primary endpoint of reduction in alkaline phosphatase (ALP) to below a threshold of 1.67 times the upper limit of the normal range, with a 15% from baseline. These levels are elevated to a higher degree in the rare primary biliary cholangitis.
The drug was granted accelerated approval by the US FDA, and a decision is currently awaited from the European Medicines Agency regarding an approval across the EU. In the UK, for example, if approved, Ocaliva would become the first new treatment in over 20 years for people with the disease.
Leading UK PBC expert and consultant physician, Professor David Jones, says: “For patients suffering from Primary Biliary Cholangitis, an autoimmune liver disease, there is currently only one treatment available other than liver transplant. There is an urgent need for a second line treatment so that many of these transplants become unnecessary. This major study provides hope that this new treatment – the first in 20 years – could transform the lives of many of the estimated 20,000 UK patients suffering from this debilitating condition.”
Sean Murray
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