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Morning Rounds: Intercept Pharmaceuticals Inc. (ICPT) REGENERATE trial for NASH


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OCALIVA for treatment of NASH

Non-alcoholic steatohepatitis (NASH) is becoming an increasingly popular disease affecting many worldwide. This disease leads to increased liver-related mortality secondary to liver cirrhosis (fibrosis) and even hepatocellular carcinoma (liver cancer). To date, there is no known FDA approved drug therapy for this disease and generally, 15-20% of patients with NASH will require a liver transplant.

The cure for NASH may potentially be the last blockbuster disease without a cure. Which is why there is an increasing number of biotech companies in a race to find a cure for this disease. Below you can see a list of companies with drugs in various different clinical trial stages asper FDAtracker.com.

 

Ocaliva (Obeticholic acid) is a 6-ethylchenodeoxycholic acid (obeticholic acid), a synthetic variant of the natural bile acid chenode oxycholic acid, is a potent activator of farnesoid X nuclear receptor. Stimulation of the farnesoid X nuclear receptor, promote insulin sensitivity and decrease hepatic gluconeogenesis and circulating triglycerides. Ocaliva has been used in pre-clinical studies, it improved hepatic steatosis, fibrosis, and portal hypertension.

Intercept Pharmaceuticals Inc. (ICPT) is expected to release news regarding their findings in the Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE trial) this week. Below, I breakdown the potential outcomes of this trial along with the likelihood that the company will succeed or fail with regards to getting FDA approval. Next, I highlight what the FDA will be looking for to provide approval and lastly, will provide my valuation of ICPT with associated risks and potential options play.

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Dr. Tiam Feridooni

Written by: Dr. Tiam Feridooni MD, PhD, BSc Dr. Feridooni, graduated from Dalhousie Medical School in May, 2018. Prior to enrolling in medical school, he completed his Bachelor of Science with Honours in 2010 in Biochemistry. He then obtained his PhD at Dalhousie University in Pharmacology in 2014, with a focus around regenerative medicine and stem cell transplantation. Dr. Feridooni has been published numerous high impact journals and has also co-authored a few books.

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