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.