Adolor Corporation (NasdaqGM: ADLR) today announced results from
a Phase 2a clinical trial of ADL5859 and ADL5747 in patients with
osteoarthritis (OA). The trial was a randomized, double-blind,
placebo-controlled, multi-center trial designed to evaluate the
safety, tolerability and clinical activity of ADL5859 and ADL5747
in patients with OA of the knee. The study enrolled over 400
patients aged 18 and older in four arms. In the three drug arms,
patients were given either ADL5859 (150 mg), ADL5747 (150 mg) or
oxycodone CR (20 mg) twice daily for two weeks. The primary
efficacy endpoint was reduction in pain score as measured by the
numeric pain rating scale (NPRS), an 11-point categorical scale,
for week two of the study. To be eligible for inclusion in the
trial, patients must have reported an average weekly pain score of
at least 4.0 on the NPRS for the index knee during the baseline
week before randomization.
Top-line results of the study showed a high placebo response,
with neither oxycodone CR nor ADL5859 nor ADL5747 demonstrating a
statistically-significant improvement over placebo. Both ADL5859
and ADL5747 were well tolerated when given at 150 milligrams twice
daily.
“We obviously are disappointed with the results of this study,”
said Eliseo O. Salinas, M.D., Senior Vice President, Research &
Development and Chief Medical Officer of Adolor. “The extent of
placebo response was surprising, but unfortunately not unusual in
osteoarthritis studies. Pfizer and we expect to fully assess this
data set over the coming weeks and make a determination as to
whether additional testing of the delta compounds in chronic
inflammatory pain indications is warranted. Our Phase 2a clinical
study of ADL5747 in post-herpetic neuralgia continues, with
top-line data expected in the first quarter of 2011.”
“As analysis continues on the delta study results, we remain
focused at Adolor on our opioid bowel dysfunction (OBD) program,
which has advanced rapidly into clinical evaluation in opioid
patients,” said Michael R. Dougherty, President and Chief Executive
Officer of Adolor. “We continue to maintain a solid cash position,
and are intent on preserving our financial strength to ensure that
we can optimally realize the opportunity our OBD program presents.
We anticipate being in a position to update investors more fully in
the near term.”
About ADL5859 and ADL5747
ADL5859 and ADL5747 are novel delta opioid receptor agonists
discovered by Adolor. There are three major classes of opioid
receptors – mu, kappa and delta. Currently, all marketed opioid
analgesic drugs used to treat moderate-to-severe pain interact with
mu opioid receptors in the brain and spinal cord.
Pfizer Inc and Adolor currently are evaluating ADL5747 in a
Phase 2a study of patients with post-herpetic neuralgia (PHN) to
evaluate the safety and efficacy of this compound in addressing
neuropathic pain. This study began in the first quarter of 2010 and
is expected to conclude early in 2011, with an interim analysis to
be conducted later this year.
Delta agonists are of particular interest because of their
potential to deliver opiate-like analgesia without many of the
negative side effects associated with traditional mu agonists like
morphine. Both FDA and the medical community are focused on the
dependency and abuse characteristics of traditional opioids. Delta
agonism may address these issues with a unique mechanism of action,
unlike current industry efforts to reformulate existing opioid
therapeutics to address abuse concerns.
Conference Call Information
Adolor's management will provide a clinical update in a
conference call with investors beginning at 4:45 p.m. EDT today,
June 17, 2010.
To participate in the conference call, dial (866) 700-6293 for
domestic callers and (617) 213-8835 for international callers, and
enter the conference passcode 81520857. Investors also can listen
to the call live by logging on to the Company's website at
www.adolor.com and clicking on "Investor Insights," then "Calendar
of Events." A replay of the call will be available beginning
approximately two hours after the event. To listen to a replay of
the conference call, dial (888) 286-8010 (domestic) or (617)
801-6888 (international) and enter the conference passcode 88515066
or listen via Adolor's website. The conference call replay will be
available to investors for one week after the call.
About the Adolor/Pfizer Collaboration
Adolor and Pfizer entered into a collaboration agreement in
December 2007 for the development of delta agonists to treat
pain.
About Adolor
Adolor Corporation is a biopharmaceutical company specializing
in the discovery, development and commercialization of novel
prescription pain management products.
Adolor’s first approved product in the United States is ENTEREG®
(alvimopan), which is indicated to accelerate the time to upper and
lower gastrointestinal recovery following partial large or small
bowel resection surgery with primary anastomosis. ENTEREG is
available for short-term use in hospitals registered under the
E.A.S.E.™ Program. For more information on ENTEREG, including its
full prescribing information, visit www.ENTEREG.com. In
collaboration with GSK, the Company launched ENTEREG in
mid-2008.
In addition to the delta compounds, the Company’s research and
development pipeline includes: two mu opioid receptor antagonists,
ADL7445 and ADL5945, in clinical development for chronic OBD; and
several opioid and non-opioid discovery programs.
For more information, visit www.adolor.com.
Forward-Looking Statements
This press release, and oral statements made with respect to
information contained in this release, may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements provide Adolor’s
current expectations or forecasts of future events. These may
include statements regarding ENTEREG net product sales guidance for
the year ending December 31, 2010 and market prospects for ENTEREG;
anticipated scientific progress on Adolor’s research programs;
development of potential pharmaceutical products, including the
delta opioid receptor agonist and OBD programs and the timing and
results of any clinical studies of our compounds, including the
expected timeline for the completion of the PHN study;
interpretation of clinical results; prospects for regulatory
approvals; and other statements regarding matters that are not
historical facts. You may identify some of these forward-looking
statements by the use of words in the statements such as
“anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,”
“believe” or other words and terms of similar meaning or that
otherwise express contingencies, goals, targets or future
development. These statements are based upon management’s current
expectations and are subject to risks and uncertainties, known and
unknown, that could cause actual results and developments to differ
materially from those expressed or implied in such statements due
to general financial, economic, regulatory and political conditions
affecting the biotechnology and pharmaceutical industries, as well
as more specific risks and uncertainties facing Adolor such as
those set forth in its reports on Forms 8-K, 10-Q and 10-K
filed with the U.S. Securities and Exchange Commission. Adolor
urges you to carefully review and consider the disclosures found in
its filings which are available at www.sec.gov and from Adolor at
www.adolor.com. Given the uncertainties affecting pharmaceutical
companies such as Adolor, any or all of these forward-looking
statements may prove to be incorrect. Therefore, you should not
rely on any such factors or forward-looking statements. Adolor
undertakes no obligation to publicly update or revise the
statements made herein or the risk factors that may relate thereto
whether as a result of new information, future events, or
otherwise, except as may be required by law.
This press release is available on the website
http://www.adolor.com.
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