DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/cw295n/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid - Clinical/regulatory update" report to their offering.
Obeticholic acid (OCA) is a derivative of chenodeoxycholic acid, the dominant component of bile. It is a potent stimulator of farnesoid X receptor and in that way differs both from chenodeoxycholic acid and ursodeoxycholic acid (URSO), another bile acid used therapeutically. Intercept is developing OCA for use in a variety of liver diseases.
Primary biliary cirrhosis (PBC), an orphan inflammatory disease of bile ducts, is the lead indication. But non-alcoholic steatohepatitis (NASH), a liver disorder that substantively overlaps with the epidemiology and pathophysiology of the metabolic syndrome is close behind. Intercept has also initiated/reported pilot efforts in bile acid diarrhea (BAD), acute alcoholic hepatitis, and portal hypertension.
This report explores recent developments in these programs in depth, with an eye toward the complex regulatory situation they face. That is, no clear precedents exist and the adverse outcomes one wishes to avoid via therapy are long term. Especially for NASH, the population needing treatment is large and the ability to identify those who will have poor outcomes is difficult.
Safety concerns complicate the picture further. Thus, endpoint selection and FDA's acceptance of data showing impact on those measures becomes a central issue when assessing the probabilities of regulatory success.
Key Topics Covered:
Introduction and background
Primary biliary cirrhosis (PBC)
- The disease (Medscape.com)
- Phase II, including long-term extension data (ICPT 2013 10-K)
- POISE (ICPT March 16 release)
- Accelerated Approval in PBC and surrogates of transplant-free survival
- Will one study be enough?
Non-alcoholic steatohepatitis (NASH)
NAFLD and NASHa brief review
- Phase II study in diabetic NAFLD
- The FLINT study
- Endpoint issues and approval pathways for NASH
- In summary
- Update on lipid changes in phase II studies of fatty liver
Update on other indications
- Other indications
For more information visit http://www.researchandmarkets.com/research/cw295n/intercept