Furiex Announces Results for Phase II Trial of PPD-10558
December 08 2011 - 5:00PM
Business Wire
Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today announced
top-line results from the Phase II trial of the investigational
drug PPD-10558 in patients with statin-associated myalgia, or SAM.
PPD-10558 did not meet its primary efficacy endpoint in this
randomized, double-blind, proof-of-concept study. The study
enrolled patients with high cholesterol and a prior history of SAM,
and evaluated recurrence rates for SAM over a twelve-week treatment
period across the following three different treatment regimens:
placebo; PPD-10558; and atorvastatin (Lipitor®). Patients did not
report any significant differences in muscle symptoms, nor did they
drop out due to SAM in significantly different percentages, among
the three regimens. As expected, however, PPD-10558, a novel
statin, did significantly lower LDL-cholesterol compared with
placebo, and the compound also had a favorable safety profile.
“We are disappointed with the results, given the promising
pre-clinical profile of PPD-10558. We were surprised to see
drop-out rates due to muscle symptoms in the placebo treatment
group that were comparable to the PPD-10558 and atorvastatin
treatment groups,” said June Almenoff, M.D., Ph.D., president and
chief medical officer of Furiex. “We, however, are confident that
the study effectively evaluated the clinical hypothesis, and has
provided a clear scientific result.”
“Given the results of this recent Phase II clinical trial,
Furiex will not move forward with PPD-10558,” said Fred Eshelman,
Pharm.D., chairman of Furiex. “We will continue to advance our
other clinical programs and remain committed to our product
portfolio and pipeline to support and create value for the
company.”
Furiex acquired an exclusive license rights in early 2007 from
Ranbaxy Laboratories, Ltd. to develop, manufacture and market its
novel statin PPD-10558 for the treatment of dyslipidemia. Furiex
will owe a $1.0 million milestone payment to Ranbaxy upon
completion of the final report for the Phase II study.
About Furiex Pharmaceuticals
Furiex Pharmaceuticals is a drug development collaboration
company that uses innovative clinical development design to
accelerate and increase value of internal and partnered drug
programs by advancing them through the drug discovery and
development process in a cost-efficient manner. 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 product
portfolio and pipeline with multiple therapeutic candidates
including late-stage assets and two products on the market. The
company’s mission is to develop innovative medicines faster and at
less cost, reducing the expense of health care globally 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: our continuing losses and potential need to raise
additional capital; risks inherent in funding, developing and
obtaining regulatory approvals of new, commercially-viable and
competitive products and treatments, including the risks that any
product under development may fail, may not achieve the expected
results or effectiveness and may not generate data that would
support the approval or marketing of products for the indications
being studied; potential FDA changes to its regulatory guidance
applicable to approval of therapeutic candidates; time required to
gain regulatory approvals; the demand for our potential products,
if and when approved; the ability to obtain adequate patent
coverage; and the costs of defending or prosecuting any patent
opposition or litigation necessary to protect our proprietary
technologies; 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.
(MM) (NASDAQ:FURX)
Historical Stock Chart
From Jun 2024 to Jul 2024
(MM) (NASDAQ:FURX)
Historical Stock Chart
From Jul 2023 to Jul 2024