Adolor Corporation Initiates Phase 2 OIC Study of ADL5945
October 19 2010 - 7:30AM
Business Wire
Adolor Corporation (NasdaqGM:ADLR) today announced the
initiation of a Phase 2 proof-of-concept (PoC) study of ADL5945 in
patients suffering from opioid-induced constipation (OIC).
“We are pleased to announce the initiation of our Phase 2
proof-of-concept study,” said Michael R. Dougherty, President and
Chief Executive Officer. “We begin this study having just completed
a single-ascending dose (SAD) study of ADL5945 in healthy
volunteers and a multiple-ascending dose (MAD) study in OIC
patients with chronic non-cancer pain. The results were highly
encouraging on all fronts: PK profile, tolerability and efficacy.
Adolor has a wealth of expertise in this indication, and we look
forward to the completion of this trial next summer.”
The Phase 2 PoC trial will evaluate two doses of ADL5945 (0.10mg
and 0.25mg given twice daily) versus placebo in patients with OIC
over a four week period. Approximately 120 patients will be
enrolled. The primary endpoint of the study will be change from
baseline in the weekly average of spontaneous bowel movements
(SBMs) during treatment.
The recently completed SAD and MAD studies of ADL5945 and
ADL7445 enrolled both healthy volunteers and non-cancer pain
patients on long-term opioid therapy with OIC. Both compounds were
well-tolerated and, in the patients with OIC, produced increases in
weekly average SBMs compared to placebo. Notably, the 0.10mg and
0.25mg doses of ADL5945 being tested in the PoC study were
successfully evaluated in extended cohorts in the MAD study against
placebo. The most commonly reported side effects were
dose-dependent gastrointestinal-related effects such as abdominal
cramping and nausea. There were no serious adverse events
reported.
“The data from this recent trial validate both ADL5945 and
ADL7445 for the treatment of OIC in patients with chronic
non-cancer pain,” said Richard M. Mangano, Ph.D., Vice President of
Clinical Research & Development at Adolor. “The safety and
efficacy of these doses of ADL5945 are encouraging and clearly
warrant continued clinical development.”
About ADL5945 and ADL7445
ADL5945 is a proprietary, peripherally-acting mu opioid receptor
antagonist being developed by Adolor for the treatment of OIC.
ADL5945 was licensed from Eli Lilly and Company in 2009 and
currently is being evaluated in a Phase 2 proof-of-concept trial in
patients with OIC.
ADL7445 also is a proprietary, peripherally-acting mu opioid
receptor antagonist being evaluated for the treatment for OIC.
ADL7445 was discovered by Adolor scientists and, like ADL5945, was
evaluated in the recently completed SAD and MAD studies. In those
studies, ADL7445 was well-tolerated and demonstrated efficacy in
patients with OIC. While ADL5945 is advancing at this point into
proof-of-concept evaluation, further investment by Adolor in
ADL7445 will continue and the Company considers ADL7445 an
important asset in its OIC program.
About Adolor
Adolor Corporation is a biopharmaceutical company specializing
in the discovery, development and commercialization of novel
prescription gastrointestinal and pain management products.
Adolor’s first approved product in the United States is
ENTEREG®, 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.
The Company's research and development pipeline includes:
ADL5945 and ADL7445, novel mu opiate receptor antagonists
undergoing clinical development for chronic OIC; two novel delta
opioid receptor agonists, one of which currently is in mid-stage
clinical development in collaboration with Pfizer Inc. for
neuropathic pain; 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;
anticipated scientific progress on Adolor’s research programs;
development of potential pharmaceutical products, including the OBD
program and the timing and results of the ADL5945 Phase 2 study;
interpretation of clinical results, including the results of the
SAD and MAD studies of ADL5945 and ADL7445; 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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