Furiex Pharmaceuticals Announces Completion of Patient Enrollment for Its Phase III Clinical Trials of Eluxadoline for IBS-d

  Furiex Pharmaceuticals Announces Completion of Patient Enrollment for Its
  Phase III Clinical Trials of Eluxadoline for IBS-d

Business Wire

MORRISVILLE, N.C. -- July 15, 2013

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced completion of
patient enrollment in the company’s two ongoing Phase III clinical trials
studying eluxadoline for the treatment of diarrhea-predominant irritable bowel
syndrome, or IBS-d. Both studies met their target enrollments and Furiex
expects to release top line results in the first quarter of 2014.

The two Phase III trials have the same overall design and efficacy endpoints,
but differ in overall duration. One study has a 52-week treatment period and
the other a 30-week treatment period. Each study has three treatment arms,
placebo, 75 mg eluxadoline twice a day and 100 mg eluxadoline twice a day,
with approximately 375 patients per arm, and is designed to capture both the
U.S. Food and Drug Administration and the European Medicines Agency endpoints
for treatment of IBS-d.

“Final completion of enrollment in the Phase III clinical trials for
eluxadoline brings us one step closer to our goal of submitting a New Drug
Application,” said June Almenoff, M.D., Ph.D., president and chief medical
officer of Furiex, “We believe there is an unmet need for IBS-d treatment that
has efficacy in both pain and diarrhea, with good tolerability and a
convenient dosing schedule.”

About Eluxadoline

Eluxadoline is a first-in-class, locally-acting mu opioid receptor agonist and
delta opioid receptor antagonist in Phase III development for treatment of
IBS-d. In vivo studies indicate that the activity of eluxadoline at the two
different opioid receptors controls GI function as well as decreases pain and
potentially mitigates the constipating effect of unopposed mu agonism.
Eluxadoline is locally active in the gut with very limited systemic
bioavailability, thus potentially decreasing central nervous system effects
and other systemic side effects associated with therapies currently used to
manage IBS-d.

About IBS-d

Diarrhea-predominant irritable bowel syndrome is a functional bowel disorder
characterized by chronic abdominal pain and frequent diarrhea, which affects
approximately 12 million Americans. Although the exact cause of IBS-d is not
known, symptoms are thought to result from a disturbance in the way the gut
and nervous system interact. IBS-d can be extremely debilitating and there are
limited therapeutic options for managing the chronic symptoms. IBS-d is
associated with economic burden in direct medical costs and indirect social
costs such as absenteeism and lost productivity, along with decreased quality
of life.

About Furiex

Furiex Pharmaceuticals is a drug development collaboration company that uses
innovative clinical development design to accelerate and increase value of
drug development programs by advancing them through the drug discovery and
development process in a cost-efficient manner. Our drug development programs
are designed and driven by a core team with extensive drug development
experience. The company collaborates with pharmaceutical and biotechnology
companies and has a diversified product portfolio and pipeline with multiple
therapeutic candidates, including one Phase III-ready asset, two compounds in
Phase III development, one of which is with a partner, and four products on
the market. The company's mission is to develop innovative medicines faster
and at a lower cost, thereby improving profitability and accelerating time to
market while providing life-improving therapies for patients. For more
information, visit www.furiex.com.

Except for historical information, all of the statements, expectations and
assumptions contained in this news release are forward-looking statements that
involve a number of risks and uncertainties. Although Furiex attempts to be
accurate in making these forward-looking statements, it is possible that
future circumstances might differ from the assumptions on which such
statements are based. In addition, other important factors which could cause
actual results to differ materially include the following: the inability to
show sufficient efficacy and safety of eluxadoline; successful submission,
review and approval of a new drug application by the U.S. Food and Drug
Administration (FDA) and a marketing authorization application by the European
Medicines Agency (EMA) for eluxadoline; decisions by regulatory agencies, such
as the FDA, EMA and Drug Enforcement Agency, regarding labeling, scheduling
and other matters that could affect the availability or commercial potential
of eluxadoline; potential changes to regulatory guidance applicable to
approval of irritable bowel syndrome drugs; future clinical data and analysis,
including post marketing; the need to find collaborators to help develop and
commercialize eluxadoline; continuing losses and our potential need for
additional financing; and the other risk factors set forth from time to time
in the SEC filings for Furiex, copies of which can be found on our website.

Contact:

Furiex Pharmaceuticals, Inc.
Media/Analysts/Investors:
Sailash Patel, 919-456-7814
sailash.patel@furiex.com
 
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