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 The drug, obeticholic acid (OCA), is designed to
treat primary biliary cirrhosis, a disease in which bile ducts in
the liver become damaged, allowing harmful substances to build up
and scar liver tissue.
Symptoms include dry eyes, fatigue, jaundice, pain in the abdomen,
swollen feet and ankles, fatty deposits on the skin around eyes or
in the creases of palms, soles, elbows and knees. It is thought to
be an autoimmune disorder, in which the body's immune system
mistakenly attacks its own cells.
The findings come roughly two months after a clinical trial of the
drug in patients with nonalcoholic steatohepatitis, a disease
characterized by a buildup of fat in the liver, was halted early
because the drug was working better than expected. The news sent the
company's shares up 281 percent.
The latest trial, known as POISE, indicates "that OCA clearly
produced clinically meaningful improvements," said Professor
Frederik Nevens, chairman of the department of hepatology at the
University of Leuven in Belgium and the lead investigator on the
trial.
Nevens said in a statement that a significant proportion of patients
fail to be adequately helped by existing treatments and that new
therapies are needed to prevent their disease from progressing to
cirrhosis and liver failure.
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"I believe that the POISE data indicate OCA will provide a
meaningful clinical improvement in these patients," he said.
(Reporting by Rodrigo Campos; editing by
Matthew Lewis)
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