Intercept Pharmaceuticals, Inc. ICPT announced positive additional supportive data from its pivotal phase III REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver known as steatosis.
Shares of the company have rallied 19.7% in the past year compared with the industry’s growth of 11.4%.
The additional supportive efficacy analyses were conducted in patients who completed greater than or equal to 15 months of treatment, had a month 18/end of treatment biopsy, were on investigational product for at least 30 days immediately preceding the biopsy, and did not have any major protocol deviations.
The additional supportive efficacy analyses showed that about three-fold more patients in the OCA 25 mg group achieved an improvement of fibrosis by ≥2 stages compared to placebo. In an analysis of changes in fibrosis by ≥1 stage, about three-fold more patients in the OCA 25 mg group (38%) improved versus worsened (13.1%). However, in the placebo group, a similar proportion of patients improved (23.2%) versus worsened (20.9%). OCA showed significant improvement in patients with liver fibrosis due to NASH, and demonstrated consistent efficacy across multiple histologic and biochemical parameters.
In the primary efficacy analysis, as previously reported, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement (≥1 stage) without any worsening signs of NASH during the planned 18-month interim analysis. Moreover, a greater proportion of patients under both OCA treatment arms compared with placebo achieved the primary endpoint of NASH resolution, with no deterioration of liver fibrosis noticed, even though the evaluation did not reach any statistical significance.
Notably, REGENERATE is the largest ongoing phase III study, involving more than 2000 patients with fibrosis due to NASH.
The market for NASH promises potential and is expected to be one of the target areas in 2019 for most large pharma/biotech companies. This market is poised to witness rapid growth unlike other lucrative yet saturated markets like cancer. Pharma giant Merck MRK, in January 2019, 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 II diabetes.Biotech bigwig Gilead Sciences, Inc. GILD entered into a licensing and collaboration agreement with South Korea-based Yuhan Corporation to co-develop novel therapeutic candidates for the treatment of patients suffering from advanced fibrosis due to NASH.
Another Swiss pharma company, Novartis AG NVS, entered into a clinical development agreement with Pfizer in 2018. The agreement includes a clinical trial to evaluate the combination of tropifexor (LJN452) and one or more Pfizer compounds for the treatment of NASH.
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Intercept Pharmaceuticals currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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