Adolor Corporation (NasdaqGM:ADLR) today announced positive,
statistically significant top line results from its two Phase 2
studies of ADL5945 in chronic non-cancer pain patients with
opioid-induced constipation (OIC). ADL5945, a peripherally-acting
mu opioid receptor antagonist, is an investigational drug being
evaluated for the treatment of OIC as well as other associated
gastrointestinal (GI) complications. Both randomized, double-blind,
placebo-controlled studies were identical in design; Study 242
evaluated 0.25 mg and 0.10 mg of ADL5945 administered twice daily
(BID) and Study 243 evaluated 0.25 mg of ADL5945 administered once
daily (QD).
“Opioid analgesics have become a cornerstone of multimodal
therapy for the management of patients who suffer with chronic
non-cancer pain,” said Neil Singla, M.D., Department of
Anesthesiology, Director, Clinical Research, Huntington Memorial
Hospital in Pasadena, California, and lead investigator for the
Phase 2 program. “Unfortunately, OIC presents a very serious burden
to most patients treated on long-term opioid therapy, and currently
there are no adequate therapies to address this common and
debilitating condition. The results of these studies of ADL5945 are
very encouraging – demonstrating both clinically meaningful effects
and a favorable tolerability profile.”
“Our Phase 2 program achieved all of our objectives and
validates our view that ADL5945 is a potentially important drug for
patients suffering from OIC and related GI symptoms,” said Michael
R. Dougherty, Adolor’s President and CEO. “Adolor has extensive
experience in this therapeutic area that we will continue to
leverage as we now focus on the Phase 3 program. There has been
significant interest in ADL5945 and we look forward to sharing
these data and initiating pivotal studies as expeditiously as
possible.”
Study Results
Twice-daily Dosing (Study 242)
Statistical significance (p = 0.0003) was achieved for the
primary endpoint in the 0.25 mg BID dose group. The primary
endpoint of both studies was the change from baseline in the weekly
average number of spontaneous bowel movements (SBMs). Response to
treatment was dose dependent in Study 242, with an average change
from baseline in SBM frequency over the 4-week treatment period of
1.4 SBMs for the placebo group, and 2.0 and 3.4 SBMs for the 0.10
mg and 0.25 mg doses of ADL5945, respectively. Statistical
significance was not achieved for the 0.10 mg dose.
Statistical significance (p = 0.005) also was achieved in the
0.25 mg BID dose group for a key secondary endpoint, a responders
analysis, with a 56% response rate for the active arm and a 26%
response rate for the placebo arm of the study. This translates
into a clinically relevant number needed to treat (NNT) of 3.3. For
this analysis, responders were defined as those patients who
achieved an average weekly frequency of at least three SBMs and an
increase of at least one SBM above baseline.
Other exploratory endpoints (patients’ global impression of
change, BM comfort and satisfaction scores) demonstrated greater
improvement as compared to baseline in the ADL5945 0.25 mg
treatment group as compared to placebo.
Once-daily Dosing (Study 243)
In Study 243, statistical significance (p= 0.01) also was
achieved for the primary endpoint. The average change from baseline
in SBM frequency over the 4-week treatment period was 1.4 SBMs for
the placebo group and 2.6 SBMs for the 0.25 mg ADL5945 treatment
group.
Although the proportion of responders was higher in the 0.25 mg
treatment group (42.5% vs. 29.3% in placebo), statistical
significance was not achieved.
Other exploratory endpoints evaluating changes in bowel function
trended in favor of ADL5945 as compared to placebo.
Safety and Tolerability
ADL5945 was well tolerated in both studies. The overall number
of patients reporting at least one treatment-emergent adverse event
was comparable across both studies (ADL5945: 29%; placebo: 26%).
There was no evidence of drug-related central opioid withdrawal or
reversal of analgesia in any of the ADL5945 treatment groups across
both studies.
Additional information concerning the efficacy and safety
results from Study 242 and Study 243 is included in the slide
presentation that will accompany the investor conference call.
Conference Call Information
Adolor's management will discuss the results of the Phase 2
studies in a conference call with investors beginning at 8:30 a.m.
ET Wednesday, August 10, 2011.
To participate in the audio portion and have the opportunity to
pose questions, dial 866-202-3109 for domestic callers or
617-213-8844 for international callers, and enter Conference ID #
62949696. Investors also can listen to the call live and view a
slide presentation 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 Conference ID # 75827916 or listen via Adolor’s website.
The replay will be available for one week.
About ADL5945
ADL5945 is a potent, peripherally-acting mu opioid receptor
antagonist intended to block the adverse effects of opioid
analgesics on the GI tract without compromising centrally-mediated
analgesia. Peripheral mu opioid receptors in the GI tract regulate
functions such as motility, secretion and absorption. Stimulation
of these GI mu opioid receptors by morphine, or other opioid
analgesics, disrupts normal gut motility.
About OIC
Over 250 million opioid prescriptions are written annually in
the United States. For those patients treated with prescription
opioids for long-term pain management, many will develop
constipation, as well as other associated gastrointestinal
complications. Currently, there are no FDA-approved therapies to
treat opioid-induced constipation in patients with chronic
non-cancer pain.
About Adolor
Adolor Corporation is a biopharmaceutical company specializing
in the discovery, development and commercialization of novel
prescription pain and 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 only for short-term (15 doses) use in hospitalized
patients. Only hospitals that have registered in and met all of the
requirements for the ENTEREG Access Support and Education
(E.A.S.E.) program may use ENTEREG. For more information on
ENTEREG, including its full prescribing information, the Boxed
Warning regarding short-term hospital use and the E.A.S.E.®
Program, visit www.ENTEREG.com.
The Company's research and development pipeline includes novel
mu opioid receptor antagonists undergoing clinical development for
chronic OIC; and several earlier-stage compounds under development
for the management of pain and CNS disorders.
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 market prospects for ENTEREG; the
development of potential pharmaceutical products such as ADL5945,
including whether the results seen in the Phase 2 studies will be
seen in future clinical studies, whether ADL5945 will be an
important drug for patients suffering from OIC, whether the Company
will be able to successfully leverage its experience in the OIC
therapeutic area in the Phase 3 program, whether there will
continue to be external interest in ADL5945 and the timetable for
the initiation of pivotal testing; prospects for regulatory
approvals; anticipated scientific progress on Adolor’s research
programs; 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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