NIH Says Patients on Intercept Drug Had More 'Bad' Cholesterol
Patients in Clinical Trial Also Showed Improvements in Their Liver Health
NIH Says Patients on Intercept Liver Drug Had More 'Bad' Cholesterol - WSJ.com
Patients who received Intercept Pharmaceuticals Inc. ICPT +61.61% 's experimental liver-disease drug in a clinical trial experienced more abnormal cholesterol levels than those taking a placebo, in addition to improvements in their liver health, according to the National Institutes of Health.
Patients taking the drug had "disproportionate lipid abnormalities"—including worsened cholesterol levels—compared with patients who received a placebo in the 283-person study, according to the NIH. The NIH's National Institute of Diabetes and Digestive and Kidney Diseases provided the information in a written statement sent to The Wall Street Journal Friday after the markets closed.
The NIH, which sponsored the clinical trial, said it was releasing the information to give "broader context for the findings" of the trial.
Intercept on Thursday said the trial was halted early after patients taking the drug, obeticholic acid, or OCA, showed a "highly statistically significant improvement" in measures of liver health versus placebo.
That news caused Intercept's stock to soar by 516% over the past two days, from $72.39 at Wednesday's close to $445.83 at Friday's close on the Nasdaq Stock Market. At the end of the week, the New York-based startup sported a market valuation of $8.6 billion, up from $1.4 billion Wednesday.
In a phone interview Friday, Intercept Chief Executive Mark Pruzanski said Intercept also received a statement from the NIH after the market's close Friday about lipid abnormalities. He said earlier in the week, before Intercept announced the positive clinical trial results, the NIH told the company that patients taking the drug had experienced "lipid effects," but the NIH didn't provide any detail.
When Intercept announced the positive study results in a statement Thursday, "we had no concrete data with respect to lipids," Dr. Pruzanski said. "All they gave us that was concrete that we could comment on was the level of statistical significance that was the basis for the decision to stop the study early for efficacy," he said.
In its written statement Friday to The Wall Street Journal, the NIH confirmed that treatment with OCA in the study was stopped early because an interim analysis showed the drug had a "significant beneficial effect on liver damage" in patients with nonalcoholic steatohepatitis, or NASH. The disease, estimated to affect 2% to 5% of Americans, involves fat accumulation in the liver that can cause inflammation and lead to more serious liver conditions.
The NIH described the lipid abnormalities as "increased total cholesterol," with increased low-density lipoprotein cholesterol, also known as LDL or "bad cholesterol," and decreased high-density lipoprotein, or HDL, also known as "good cholesterol." Elevated LDL is considered to be a risk factor for heart disease while decreased HDL also is a risk factor.
Dr. Pruzanski said previous studies have shown that OCA can raise lipid levels, and that the company is studying these effects. He said the results of some of this research are publicly available on Intercept's website. "It's very public that our drug, among other things, impacts lipid metabolism," he said.
The NIH said while treatment is being stopped early, "the study is not over." The NIH will continue to collect information on patients until they complete their final follow-up visit 24 weeks after stopping the study drug, including on whether the "lipid problems" return to levels before patients started treatment. Lipid abnormalities are common in people with NASH, according to the NIH.
The NIH said it would make additional information available when the trial is complete and all data have been analyzed and presented to the broader scientific community, which it said would happen in 10 to 12 months.
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