LifeSci Advisors Announces Investment Opinion on Adolor Corporation
June 16 2011 - 1:00PM
Business Wire
LifeSci Advisors, LLC, a leading provider of investment research
and investor relations services in the life sciences sector, today
announced that it has initiated coverage of Adolor Corporation
(NasdaqGM: ADLR), a biopharmaceutical company focused on the
development and commercialization of novel prescription central
nervous system (CNS) and gastrointestinal (GI) products. Adolor is
a leader in the development and commercialization of novel, opioid
receptor-targeted therapeutics designed to maintain or improve
opioid-like pain relief and reduce opioid side effects. Adolor’s
currently marketed product, ENTEREG® (alvimopan), is a
peripherally-acting mu opioid receptor antagonist approved for
accelerating upper and lower GI recovery following bowel resection
surgery.
“ADL5945, Adolor’s new therapy for the treatment of
opioid-induced bowel dysfunction (OBD) with a focus on the primary
symptom, opioid induced constipation (OIC), is a potent, orally
available antagonist of peripheral mu opioid receptors in the GI
tract that has the potential to provide substantial relief to this
patient population and become a ‘best in class’ drug,” said Andrew
I. McDonald, Ph.D., Managing Director at LifeSci Advisors. “To
date, ADL5945 has been shown safe and has demonstrated strong
therapeutic potential in early clinical trials. We are anticipating
the imminent release of important Phase 2 data in 3Q 2011. ADL5945
appears to provide clinical benefit without disrupting the
analgesic effects of patients’ pain medication. This therapy has
the potential to reduce the suffering of millions of patients with
chronic non-cancer pain and OIC where other therapies such as
laxatives have failed. Pending encouraging Phase 2 results in
approximately 200 patients, Adolor will be poised to begin the
pivotal Phase 3 development program in early 2012. If approved,
ADL5945 has the potential to become a blockbuster, with worldwide
sales of more than $1 billion per year.”
In a 40-page Initiation Report by LifeSci Advisors, the clinical
profiles of ADL5945 and other competing development candidates are
elucidated. Adolor completed Phase 1 testing for ADL5945 in 2010
after testing the compound in two studies, a single ascending dose
study in healthy volunteers designed to test safety and
tolerability and establish the pharmacokinetic profile of the drug,
and a multiple ascending dose (MAD) study that enrolled non-cancer
pain patients on long-term opioid therapy with opioid induced
constipation (OIC). The MAD study identified the maximum tolerated
dose of 0.25 mg BID (Part A of the trial) and also evaluated
safety, tolerability, and clinical effect of 0.1 mg BID (n = 8) and
0.25 mg BID (n = 8) vs. placebo (n = 4) over 2 weeks (Part B of the
trial). ADL5945 was generally well tolerated with no reported
serious adverse events (SAEs) and with most AEs GI-related and mild
(none severe) in severity. The most commonly reported AE was
nausea. The measure of efficacy was an increase over baseline in
the weekly average number of spontaneous bowel movements (SBMs),
which is the same primary outcome measure that is being used in the
Phase 2 trials. Patients receiving 0.10 mg and 0.25 mg BID doses of
ADL5945 experienced average increases during the trial period of
2.7 and 5.5 SBMs/week, respectively, compared with 1.5 SBMs/week
for placebo. This study established the initial safety and proof of
mechanism of action for ADL5945.
The Phase 2 program for ADL5945 includes two trials, one testing
once-daily dosing and the other testing twice-daily dosing. The
primary outcome for the trials is change from baseline in the
weekly average number of SBMs during the four-week treatment
period. A two-week screening period precedes the four weeks of
treatment. The Phase 2 trials will enroll over 200 total adult
patients with non-cancer related chronic pain who are taking
opioids for pain management. Adolor also is using the Phase 2
trials to validate a patient reported outcomes (PRO) measurement
instrument designed to evaluate symptoms beyond constipation that
could eventually be used to broaden the indication and/or support
claims in the product label.
In addition to developing ADL5945 for opioid induced
constipation and associated symptoms, Adolor markets ENTEREG, which
is indicated to accelerate the time to upper and lower GI recovery
following partial large or small bowel resection surgery with
primary anastomosis. Adolor recently announced an agreement to
acquire full ownership of ENTEREG from GlaxoSmithKline.
Adolor also has a strong pipeline of therapies targeting unmet
medical needs in the area of pain management. The Company has
completed Phase 1 studies of ADL6906 (beloxepin), a dual
norepinephrine reuptake inhibitor and 5-HT2 (serotonin) receptor
antagonist for the treatment of pain. Additional pipeline
candidates include the backup development candidate for ADL5945,
ADL7445, and a group of centrally-acting mu opioid receptor (CAMOR)
antagonists with potential applications as an adjuvant to l-DOPA
therapy for Parkinson’s disease.
Dr. McDonald’s full Initiation Report is available to download
at no cost at the LifeSci Advisors website,
www.lifesciadvisors.com. In addition to this Initiation Report,
LifeSci Advisors also will provide ongoing coverage and event-based
research updates on the Company as developments occur.
Important Disclosures:
The research report described in this press release is not
intended as an offering, recommendation, or a solicitation of an
offer to buy or sell securities. The securities discussed in LSA
research reports may be unsuitable for some investors depending on
their specific investment objectives, financial status, risk
profile, or particular needs. Investors should consider LSA reports
as only a single factor in making their investment decisions and
should not rely solely on these reports in evaluating whether or
not to buy or sell the securities of the subject company.
LifeSci Advisors has been compensated by the company that is the
subject of the report described and is also compensated for
investor relations services and general consulting services. Please
read each report's full disclosures and analyst background on the
LSA website, www.lifesciadvisors.com, before investing. LifeSci
Advisors is not a registered investment adviser or
broker-dealer.
Forward-looking
statements:
This press release contains forward-looking
statements subject to risks and uncertainties that could cause
actual results to differ materially from those projected. These
forward-looking statements represent LSA's judgment as of the date
of this release. LifeSci Advisors disclaims, however, any intent or
obligation to update these forward-looking statements.
Adolor Corp. (MM) (NASDAQ:ADLR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Adolor Corp. (MM) (NASDAQ:ADLR)
Historical Stock Chart
From Jul 2023 to Jul 2024