Intercept Pharmaceuticals is on the verge of obtaining FDA approval for the very first NASH drug



Intercept Pharmaceuticals Inc.

ICTP, + 6.75%

Tuesday announced that a potential therapy against fatty liver called NASH had achieved its primary goal in a Phase 3 trial a week after Gilead Sciences Inc.

BROWN, -0.70%

announced that a rival trial had failed.

Intercept shares rose 4% on Tuesday morning.

There is no approved treatment for NASH or non-alcoholic steatohepatitis, a serious liver disease caused by a build-up of fat in the liver that can lead to chronic inflammation, scarring or fibrosis. Ultimately, the disease can lead to liver failure, cancer and death.

Treatment with Intercept, Obstetric Acid (OCA), is intended for the treatment of patients with liver fibrosis due to NASH. The phase 3 trial was conducted in 931 patients with liver fibrosis randomly assigned to placebo or one of two doses of OCA.

After 18 months, the results were as follows: 23.1% of patients receiving the highest dose of OCA had a statistically significant reduction in liver fibrosis, compared with 17.6% of those receiving the lowest dose and 11.9% of those receiving placebo, which has two main objectives of the trial. However, although OCA patients experienced a reduction in liver fat and inflammation compared to placebo-treated patients, the difference was not statistically significant, which means that the trial did not reaches its second main criterion. A previous agreement between Intercept and the US Food and Drug Administration stipulated that the test had to fulfill only one of the two main objectives to be considered a success.

"These results, which demonstrate the ability of OCA to significantly improve fibrosis in patients with advanced disease, are very encouraging," said Zobair M. Younossi, chairman of the executive committee of the essay and professor at the Department of Medicine at Inova Fairfax Medical Campus. declaration.

Lily: Large biotech companies have eliminated $ 100 billion of share buybacks in the bathroom

The most common adverse reaction observed with this drug was itchy skin: 51% of the patients in the highest dose group and 28% of the lowest dose group reported itching, compared to 11% in the the placebo group. Severe skin itching was reported in 5% of patients receiving the highest dose, 9% of whom then decided to discontinue treatment.

OCA treatment was also associated with an increase in LDL cholesterol, which is consistent with what researchers had found in previous studies on NASH, although the number of cardiovascular events was similar in all treatment groups.

Intercept has announced its intention to file for approval in the United States and Europe in the second half of 2019.

If approved, Intercept's drug would be the first to treat liver disease, a leading cause of liver transplantation. Biotech Galectin Therapeutics Inc.

GALT, + 0.00%

is also working on a phase 3 NASH and Novartis therapy

NVS, + 0.06%

NOVN, + 0.00%

and Pfizer

PFE, + 0.80%

announced in October their intention to combine a Novartis drug for NASH with several Pfizer molecules targeting the same disorder.

Related: Novartis and Pfizer Join Forces to Fight Liver Disease

Gilead, a previous leader in the race for the discovery of a cure for NASH, announced last week that his drug had not reached the primary goal of a trial of phase 3. Gilead's shares fell 0.4% on Tuesday.

Intercept shares have grown 97% in the last 12 months, while the iShares Nasdaq Biotechnology ETF

BWI -0.49%

gained 1.3%. The S & P 500

SPX, + 0.19%

the index gained 1.7%.


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