8/12/2014 6:07:48 AM
Intercept Pharmaceuticals Soars As Liver Drug Found Effective In Mid-Stage Trial
August 12, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Intercept Pharmaceuticals (ICPT) , a biopharmaceutical company, saw its stock price surge 60% in after-hours trading on Monday. At the closing bell, the price had reached $237.18; after closing, the price peaked at $378.50. The stock movement occurred in the wake of an announcement about their lead product candidate, obeticholic acid (OCA), which is being developed to treat chronic liver diseases. A statistically significant improvement was found in patients who had received the OCA treatment versus those who had received the placebo. In addition, safety concerns about the side effects of OCA have now been put to rest, with the company set to move forward with Phase III trials in early 2015.
In January 2014, the FDA stopped the study, referred to as FLINT, when it became evident that patients receiving OCA treatment experienced statistically significant positive results. The company’s share price quadrupled on the day of that announcement, but began to fall as concerns about the treatment’s safety arose in the following months. Investors had been eagerly awaiting the full results of the study to see if safety concerns about the side effects had been borne out.
According to the company, FLINT, sponsored by the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK), a part of the National Institutes of Health, was a “multi-center, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of a 25 mg oral dose of OCA administered daily to biopsy-proven adult NASH patients over a 72-week treatment period.”
NASH, or Nonalcoholic steatohepatitis, is a common liver disease that resembles alcoholic liver disease but occurs in people who drink little or no alcohol. The underlying cause of NASH is unclear, but it most often occurs in middle-aged overweight or obese people.
By the study’s primary measurement, a reduction in the NAFLD Activity score (NAS) with no increase in liver scarring, 46% of NASH patients responded to OCA versus 21% in the placebo group—a statistically significant result. For the secondary measurement, which was NASH resolution, or eradication of the condition, only 22% of OCA-treated patients achieved this result versus 13% of placebo-treated patients—not a statistically significant result. According to Adam Feuerstein, of the Street, the most surprising finding of the FLINT study was the fact that, “Thirty-five percent of OCA-treated patients reported a reduction in liver fibrosis, or scarring, compared to 19% of placebo-treated patients.” Few people expected this result, especially in a study lasting only 72 weeks.
OCA-treated patients did experience a statistically significant increase in LDL, or bad cholesterol, and reduction in HDL, or good cholesterol during the study. However, this issue was resolved with follow-up treatments within two months of the end of the study.
The company will present the data of the study at the American Association for the Study of Liver Disease annual meeting this fall and will publish it in a peer-reviewed journal.
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