Reuters Health Information: Intercept drug for non-alcoholic steatohepatitis found effective
Intercept drug for non-alcoholic steatohepatitis found effective
Last Updated: 2014-08-12
By Reuters Staff
(Reuters) - Intercept Pharmaceuticals Inc's drug to treat
non-alcoholic steatohepatitis (NASH) called obeticholic acid was
effective in mid-stage trials, the company said on Monday.
There currently is no FDA approved treatment for NASH.
The company said liver scarring did not worsen in 46% of
NASH patients who were given obeticholic acid, compared with 21%
in the placebo group.
Intercept said on Jan. 9 it had stopped the trial after the
drug showed statistically significant improvement in patients.
The company's shares quadrupled on that day but lost some of
those gains in the past few months as investors raised questions
about the drug's side-effects and awaited full clinical results
of the trial.
"The fear that investors had regarding the safety of the
drug have now been put to rest with this update," Oppenheimer
analyst Akiva Felt told Reuters.
"The statistically significant results of the trial are also
a positive new development."
The company said it plans to start late-stage trials for the
drug in the first half of 2015.
The drug is also being tested as a treatment for primary
biliary cirrhosis, an autoimmune disease in which bile ducts in
the liver are destroyed.