Shares of Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) rose about 6.1% after the company announced positive top-line results from its pivotal phase III REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). Shares of the company have increased 93.4% in the past year against the industry’s decline of 15.2%.
The company stated that the primary endpoint of the study — fibrosis improvementwithout worsening of NASH at 18 months — was achieved with the 25 mg daily dose of OCA. Also, a numerically greater proportion of patients in both OCA treatment arms (taking doses of 10 mg and 25 mg) achieved the primary endpoint of NASH resolution with no worsening of liver fibrosis compared to placebo. However, this did not reach statistical significance.
Intercept plans to file for approval of OCA as a NASH treatment in the United States and Europe in the second half of 2019. The company will also report the results from the REGENERATE study at the European Association for the Study of the Liver (EASL) conference in April.
OCA is already available in the United States and Europe for treating another liver disease, primary biliary cholangitis (PBC), under the brand name Ocaliva. OCA is the only investigational drug to have received Breakthrough Therapy designation from the FDA for NASH with fibrosis.
We remind investors that last week, Gilead Sciences, Inc. (NASDAQ:GILD) announced the failure of a late-stage study (STELLAR-4) on pipeline candidate, selonsertib, in patients with compensated cirrhosis (F4) due to NASH. The study did not meet the pre-specified 48-week primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.
The market for NASH promises potential and is expected to be one of the target areas in 2019 by most large pharma/biotech companies. This market is poised to witness rapid growth unlike other lucrative yet saturated markets like cancer. A chronic liver disease, NASH is caused by excessive fat accumulation in the liver, known as steatosis. Per records, it has affected up to 15 million people in the United Stated, and could cause inflammation, hepatocellular injury, progressive fibrosis and cirrhosis.
With no treatments currently approved to address this disease, the market opportunity is substantially huge. In fact, many companies are investing a major chunk of their R&D spend in the same.
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) and Viking Therapeutics, Inc. too have promising NASH candidates in their pipeline.
Pharma giant Merck (NYSE:MRK) recently exercised its option to license NGM313, an investigational monoclonal antibody agonist of the β-Klotho/FGFR1c receptor complex that is currently being evaluated for the treatment of NASH and type 2 diabetes.
Intercept Pharmaceuticals, Inc. Price
Intercept Pharmaceuticals, Inc. Price | Intercept Pharmaceuticals, Inc. Quote
Zacks Rank
Intercept currently carries a Zacks Rank #4 (Sell).
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