) surged a whopping 281.09% in regular trading after the company
announced that the FLINT (Farnesoid X Receptor Ligand Obeticholic
Acid in Nonalcoholic Steatohepatitis Treatment) trial on its lead
pipeline candidate, obeticholic acid or OCA was stopped early
after the study met its primary endpoint.
The multi-center, double-blind, placebo-controlled phase II
trial, FLINT (n=283), is evaluating the efficacy and safety of
OCA for the treatment of nonalcoholic steatohepatitis (NASH).
The trial is being sponsored and conducted by the National
Institute of Diabetes & Digestive & Kidney Diseases
The Data Safety Monitoring Board (DSMB) reviewed liver biopsy
data through the trial in approximately half of the randomized
patients and recommended to stop the trial. The data from the
trial showed that treatment with OCA resulted in a highly
statistically significant improvement as compared to placebo,
thereby meeting the primary endpoint.
The news comes as a major milestone for Intercept Pharma as
OCA is its lead candidate. Intercept Pharma primarily focuses on
the development and commercialization of novel therapeutics to
treat chronic liver diseases.
Apart from NASH, OCA is being evaluated for other indications
like primary biliary cirrhosis (PBC), portal hypertension and
bile acid diarrhea (BAD).
We note that OCA enjoys orphan drug status in the U.S. and EU
for the treatment of PBC. Intercept owns worldwide rights to OCA
except in Japan and China, where it has out-licensed the product
candidate to Dainippon Sumitomo Pharma.
Concurrent with the results from the FLINT trial, Intercept
Pharma announced that it has obtained positive clinical data in
all six phase II clinical trials in five different indications
for OCA. The company expects data from POISE and FLINT trials in
2014, followed by the anticipated completion of the New Drug
Application (NDA) and Marketing Authorisation Application (MAA)
filings for PBC by 2014 end.
Intercept Pharma also announced positive top-line results from
the OBADIAH study which is evaluating whether OCA can stimulate
the release of FGF19 in patients suffering from primary BAD
(PBAD) and preliminary data from the PESTO trial evaluating OCA
for portal hypertension.
Intercept Pharma currently does not have any approved drug in
its kitty. Hence, we expect investor focus on OCA updates for the
PBC (POISE trial) and NASH (FLINT trial) indications.
Intercept Pharma currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same sector include
). While Actelion is a Zacks Rank #1 (Strong Buy) stock, the
other two stocks carry a Zacks Rank #2 (Buy).
ACTELION LTD (ALIOF): Get Free Report
CELGENE CORP (CELG): Free Stock Analysis
AMICUS THERAPT (FOLD): Free Stock Analysis
INTERCEPT PHARM (ICPT): Free Stock Analysis
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