Company Update (NASDAQ:ICPT): Intercept Pharmaceuticals Inc Announces Initiation of REGENERATE Trial for Obeticholic Acid in NASH Patients With Advanced Liver Fibrosis

Intercept Pharmaceuticals Inc (NASDAQ:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases, today announced the initiation of the REGENERATE trial, an international Phase 3 trial of obeticholic acid (OCA), the company’s lead FXR agonist, in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with advanced liver fibrosis. OCA is the first NASH therapy to have demonstrated reversal of liver fibrosis with a significantly greater therapeutic response versus placebo in patients at higher risk of progression to cirrhosis. The U.S. Food and Drug Administration (FDA) has designated OCA as a breakthrough therapy in NASH patients with fibrosis and REGENERATE was designed in accordance with advice from the FDA and European Medicines Agency (EMA).

The REGENERATE study population will be primarily comprised of NASH patients with stage 2 or stage 3 liver fibrosis. Advanced liver fibrosis has been shown to be the best predictor of liver transplant and mortality in patients with NASH. In addition, the trial will include an exploratory cohort of NASH patients with early stage 1 liver fibrosis and concomitant diabetes, obesity or elevated alanine aminotransferase (ALT) who are at increased risk of progression to cirrhosis.

REGENERATE has been designed as a double-blind, placebo-controlled Phase 3 clinical trial expected to enroll approximately 2,000 NASH patients at up to 300 qualified centers worldwide and assess the potential benefits of OCA treatment on liver-related and other clinical outcomes. The trial will include a pre-planned interim histology analysis after 72 weeks of treatment in 1,400 patients, which is intended to serve as the basis for seeking initial U.S. and international marketing approvals of OCA for the treatment of NASH patients with fibrosis. Two co-primary endpoints will be assessed in the interim analysis: (i) fibrosis improvement with no worsening of NASH and (ii) NASH resolution with no worsening of fibrosis.

“We are excited to embark on the REGENERATE Phase 3 trial of OCA in NASH and build on the exciting results from FLINT that demonstrated OCA’s potential to reverse advanced liver fibrosis in NASH patients,” said Mark Pruzanski, M.D., Chief Executive Officer and President of Intercept. “NASH is projected to become the leading indication for liver transplant in the U.S. by 2020 and, with no approved treatments, the disease imposes a tremendous public health burden. With REGENERATE, we hope to show that OCA treatment will prevent NASH patients with fibrosis from progressing to cirrhosis and cement its value as a breakthrough therapy for this underserved patient population.” (Original Source)

Shares of Intercept Pharmaceuticals closed last Friday at $169.84. ICPT has a 1-year high of $314.88 and a 1-year low of $128.50. The stock’s 50-day moving average is $195.14 and its 200-day moving average is $248.78.

On the ratings front, Intercept Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on August 31, Wedbush analyst Liana Moussatos maintained a Buy rating on ICPT, with a price target of $493, which represents a potential upside of 190.3% from where the stock is currently trading. Separately, on August 13, Morgan Stanley’s Andrew Berens initiated coverage with a Sell rating on the stock and has a price target of $165.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Liana Moussatos and Andrew Berens have a total average return of 14.4% and 5.8% respectively. Moussatos has a success rate of 39.1% and is ranked #166 out of 3759 analysts, while Berens has a success rate of 60.0% and is ranked #1426.

The street is mostly Bullish on ICPT stock. Out of 9 analysts who cover the stock, 7 suggest a Buy rating , 1 suggest a Sell and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $431.50, which represents a potential upside of 154.1% from where the stock is currently trading.

Intercept Pharmaceuticals Inc is a biopharmaceutical company. The Company is engaged in the development and commercialization of novel therapeutics to treat chronic liver disease utilizing its proprietary bile acid chemistry.

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