Furiex Pharmaceuticals, Inc. : Furiex Pharmaceuticals Announces First Patient Dosed in Phase III Clinical Trials of MuDelta in Diarrhea-Predominant Irritable Bowel Syndrome
06/19/2012| 04:10pm US/Eastern
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Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced dosing of
the first patient in its Phase III randomized, double-blind,
placebo-controlled studies evaluating efficacy, safety and tolerability
of MuDelta (JNJ-27018966) in the treatment of diarrhea-predominant
irritable bowel syndrome (IBS-D). Furiex is conducting two simultaneous
Phase III trials, one with a 52-week treatment period and one with a
30-week treatment period, in study centers in the United States, Canada
and United Kingdom. Combined, the trials are expected to enroll
approximately 2,250 patients.
Furiex previously announced the successful completion and outcome of its
Phase II study to assess the safety and efficacy of an oral formulation
of MuDelta in patients with IBS-D. The study achieved statistically and
clinically significant results for its primary as well as a number of
key secondary endpoints, and demonstrated durable efficacy through the
12-week treatment period.
"MuDelta is a first-in-class compound and we are extremely pleased that
the Phase III trials have commenced and look forward to further
advancing the development plan for this important therapeutic
candidate," said June Almenoff, M.D., Ph.D., president and chief medical
officer of Furiex.
Added Fred Eshelman, Pharm.D., chairman of Furiex, "We believe MuDelta
will fill an unmet need for an IBS-D treatment that has efficacy in both
pain and diarrhea, a good safety profile and a convenient dosing
schedule. It has the potential to create significant value as we
progress its development."
In November 2011, we acquired full exclusive license rights to develop
and commercialize MuDelta under our existing development and license
agreement with Janssen Pharmaceutica, N.V., or Janssen. Under the terms
of our agreement Janssen will be eligible to receive a $5 million
milestone payment upon dosing of the fifth patient in the Phase III
trial, up to $45 million in regulatory milestone payments and, if
approved for marketing, up to $75 million in sales-based milestone
payments and sales-based royalties increasing from the mid to upper
single digit percentages as sales volume increases. Royalties are to be
paid for a period of ten years after the first commercial sale or, if
later, the expiration of the last valid patent claim or the expiration
of patent exclusivity.
For more details about these trials, please visit www.clinicaltrials.gov.
About MuDelta
MuDelta is a novel, orally active, Phase III investigational agent with
combined mu opioid receptor agonist and delta opioid receptor antagonist
activity which acts locally in the gut and has very low oral
bioavailability, diminishing sedating side effects. This dual opioid
activity is designed to treat diarrhea and pain symptoms of IBS-D,
without causing the constipating side effects that can occur with mu
opioid agonists.
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 strong, 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 two 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: not completing enrollment for
the Phase III studies; terminating the Phase III studies due to changes
in the safety profile; potential Food and Drug Administration changes to
its regulatory guidance applicable to approval of irritable bowel
syndrome drugs; time and cost required to complete trials and gain
regulatory approval, and related risks, including that we might not get
approval; the need to find collaborators to help develop and
commercialize MuDelta; 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.
Media/Analysts/Investors:
Furiex Pharmaceuticals
Sailash
Patel, 919-456-7814
sailash.patel@furiex.com
© Business Wire 2012
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