Positive Results on Intercept Pharma's OCA - Analyst Blog

Intercept Pharmaceuticals, Inc. ICPT announced positive additional data from the phase III (POISE) study on obeticholic acid (OCA) being developed for the treatment of primary biliary cirrhosis (PBC). Results from the study will be presented at the International Liver Congress of the European Association for the Study of the Liver (EASL).

Additional results showed that patients treated with OCA achieved a statistically significant reduction in alkaline phosphatase (ALP) within two weeks. Moreover, the peak effect was achieved within six months of treatment.

Intercept Pharma also announced that results from a retrospective analysis of two phase II studies on OCA were presented at the International Liver Congress. Results from the analysis showed that 43% of the patients under the OCA arm achieved the primary endpoint of the POISE study as compared to 8% of the patients under the placebo arm.

Earlier in the year, Intercept Pharma reported that the candidate met its primary objective of a reduction in serum alkaline phosphatase from baseline and a normal bilirubin level post 12 months of therapy.

Intercept Pharma intends to file regulatory applications for OCA in the PBC indication in both the U.S. and EU by the end of 2014. The submissions will be based on the results from the phase III POISE study and the two phase II studies.

We note that OCA is also being developed for the treatment of nonalcoholic steatohepatitis (NASH) in a phase IIb (FLINT) study. The study is being sponsored and conducted by the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK). Full results from the FLINT study are expected in Jul 2014. We expect investor focus to stay on updates regarding OCA.

Intercept Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Amgen Inc. AMGN, Alexion Pharmaceuticals, Inc. ALXN and Agenus Inc. AGEN. While Amgen carries a Zacks Rank #1 (Strong Buy), Alexion and Agenus carry a Zacks Rank #2 (Buy).