DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/rh9xhp/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid for Liver Diseases" 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 initiation report explores these programs in depth, including the underlying rationale for use and a review of the phase II data in the lead PBC and NASH indications. It also explores issues related to the later phase trials for those indications, including the selection of endpoints. In PBC and especially in NASH, the ability to identify those who will have poor long-term outcomes (and thus would benefit from therapy) is difficult. 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.
The report also reviews the rationale and available data from the other programs and also looks at the competitive landscapes for each.
Key Topics Covered:
1. Primary biliary cirrhosis (PBC)
- The disease
- Phase II, including long-term extension data (ICPT 2013 10-K)
- Accelerated Approval in PBC and surrogates of transplant-free survival
- Will one study be enough?
- In summary
2. 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
- Update on lipid changes in phase II studies of fatty liver
3. Update on other indications
4. Summary opinion
- Other indications
- Antipodean Pharmaceuticals
- Intercept Pharmaceuticals
- Johnson & Johnson
- Kotobuki Pharmaceuticals
For more information visit http://www.researchandmarkets.com/research/rh9xhp/intercept
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