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Intercept Reports Additional Details About FLINT Trial Provided by NIDDK

Intercept Reports Additional Details About FLINT Trial Provided by NIDDK

NEW YORK, Jan. 12, 2014 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc.
(Nasdaq:ICPT) (Intercept) today provided additional information regarding the
FLINT clinical trial of obeticholic acid (OCA) in nonalcoholic steatohepatitis
(NASH), based on a written statement distributed after market close on January
10, 2014 by the National Institute of Diabetes & Digestive & Kidney Diseases
(NIDDK), a part of the National Institutes of Health.

The NIDDK confirmed in its statement that:

  *Its decision to halt the 72-week therapeutic phase of FLINT was based on
    interim efficacy results showing that "OCA has a significant beneficial
    effect on liver damage due to NASH."
    
  *As specified in the protocol, a 24-week follow up period is now commencing
    and all FLINT patients will stop taking OCA or placebo no later than
    January 20, 2014.
    
  *Both the FLINT investigators and patients enrolled in the trial will
    remain blinded until completion of the follow up phase. All the trial data
    will then be thoroughly analyzed and the NIDDK anticipates presenting the
    results in 4Q 2014.
    
  *Lipid abnormalities involving increased total cholesterol and LDL and
    decreased HDL were seen in OCA-treated patients compared to placebo.
    
  *Since lipid abnormalities are common in NASH, all of the patients will be
    followed for the 24-week period to help determine whether lipids return to
    pre-treatment levels.

While the NIDDK did not provide any information concerning the magnitude of
lipid effects, Intercept believes that the reported lipid changes in FLINT
patients on OCA will likely be similar to the results previously reported in a
clinical trial of OCA in diabetic patients with nonalcoholic fatty liver
disease (NAFLD) that were presented at the 2009 meeting of the American
Association for the Study of Liver Disease (AASLD) by Dr. Arun Sanyal and
subsequently described in a paper published in the journal Gastroenterology in
2013 (Mudaliar et al.). The efficacy results from this earlier trial (insulin
sensitization, weight loss and liver enzyme improvements), together with the
safety and tolerability profile of OCA, established the basis for its
selection as the therapeutic candidate in FLINT in 2010.

"OCA is an FXR agonist and we have known for a long time that it is involved
in many aspects of lipid metabolism," said Mark Pruzanski, M.D., Intercept's
Chief Executive Officer. "An important part of the rationale for advancing our
drug in NASH is that by activating FXR in the liver, we believe that it
reduces the excess lipid load which is a causal factor in the disease. In
addition, there is preclinical evidence that by activating FXR systemically,
OCA is able to shunt excess lipids away from collecting in arteries and other
organs which could also be beneficial. It is in any case clear that the lipid
changes seen in OCA-treated patients are part of a complex set of mechanisms
and we are already conducting further studies to gain a more complete
understanding of the clinical implications."

About Obeticholic Acid (OCA)

OCA is a first-in-class farnesoid X receptor (FXR) agonist being developed for
a variety of chronic liver and intestinal diseases including NASH, primary
biliary cirrhosis, primary sclerosing cholangitis, portal hypertension and
bile acid diarrhea. Intercept has obtained positive clinical data in all six
Phase 2 clinical trials completed to date in five different indications. OCA
has received orphan drug designation in both the United States and Europe for
the treatment of PBC. Intercept owns worldwide rights to OCA outside of Japan
and China, where it has out-licensed the product candidate to Dainippon
Sumitomo Pharma.

About Intercept

Intercept is a biopharmaceutical company focused on the development and
commercialization of novel therapeutics to treat orphan and more prevalent
liver and intestinal diseases utilizing its expertise in bile acid chemistry.
The company's lead product candidate, obeticholic acid (OCA), is a bile acid
analog and first-in-class agonist of the farnesoid X receptor (FXR).
Intercept's other product candidates include INT-767, an orally-administered
dual FXR/TGR5 agonist, and INT-777, an orally-administered TGR5 agonist.For
more information about Intercept, please visit the Company's website at:
www.interceptpharma.com.

Safe Harbor Statements

This press release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995, including, but not
limited to, statements regarding the anticipated initiation of the 24-week
follow-up stage by the NIDDK; the anticipated timeframe for the receipt of
additional results from the FLINT trial; clinical, preclinical and regulatory
developments for OCA; the mechanisms of action of OCA, including its impact on
lipid metabolism, in patients with NASH and other indications; the anticipated
timeframe for the commencement, completion and receipt of results from the
clinical trials in OCA and for the making of regulatory submissions; the
anticipated results of our clinical and preclinical trials and other
development activities; and our strategic directives under the caption "About
Intercept." These "forward-looking statements" are based on management's
current expectations of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially and
adversely from those set forth in or implied by such forward-looking
statements. These risks and uncertainties include, but are not limited to: the
initiation, cost, timing, progress and results of Intercept's development
activities, preclinical studies and clinical trials; the timing of and
Intercept's ability to obtain and maintain regulatory approval of OCA, INT-767
and any other product candidates it may develop, and any related restrictions,
limitations, and/or warnings in the label of any approved product candidates;
Intercept's plans to research, develop and commercialize future product
candidates; the election by Intercept's collaborators to pursue research,
development and commercialization activities; Intercept's ability to attract
collaborators with development, regulatory and commercialization expertise;
Intercept's ability to obtain and maintain intellectual property protection
for its product candidates; Intercept's ability to successfully commercialize
its product candidates; the size and growth of the markets for Intercept's
product candidates and its ability to serve those markets; the rate and degree
of market acceptance of any future products; the success of competing drugs
that are or become available; regulatory developments in the United States and
other countries; the performance of third-party suppliers and manufacturers;
Intercept's ability to obtain additional financing; Intercept's use of the
proceeds from its initial public offering in October 2012 and follow-on
offering in June 2013; the accuracy of Intercept's estimates regarding
expenses, future revenues, capital requirements and the need for additional
financing; the loss of key scientific or management personnel; and other
factors discussed under the heading "Risk Factors" contained in Intercept's
annual report on Form 10-K for the year ended December 31, 2012 filed on April
1, 2013 as well as any updates to these risk factors filed from time to time
in Intercept's other filings with the Securities and Exchange Commission. All
information in this press release is as of the date of the release, and
Intercept undertakes no duty to update this information unless required by
law.

CONTACT: Barbara Duncan or Senthil Sundaram
         Intercept Pharmaceuticals
         1-646-747-1000
 
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