Intercept Pharmaceuticals, Inc.
) 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).
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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
Alexion Pharmaceuticals, Inc.
). While Amgen carries a Zacks Rank #1 (Strong Buy), Alexion and
Agenus carry a Zacks Rank #2 (Buy).