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-HT 2 (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.
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