Adolor Corporation Initiates First of Three Proof of Concept Studies of Novel Delta Opioid Agonist for the Management of Pain
- Category: Small Molecules
- Published on Tuesday, 10 July 2007 04:00
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EXTON, PA, USA | July 9, 2007 | Adolor Corporation (Nasdaq:ADLR) announced today the initiation of a Phase 2 study of ADL5859, a novel delta opioid agonist in development for the treatment of pain. Study 33CL230 targets dental pain and is the first of several planned proof of concept studies designed to explore the analgesic efficacy of ADL5859 across a range of acute, inflammatory and neuropathic pain indications. Completion of Study 33CL230 is targeted for early 2008.
"Delta agonists offer the potential to treat pain with a novel mechanism of action," said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. "We are pleased to initiate this Phase 2 program which results from our internal research efforts and our proprietary platform in opioid receptor technology. Delta compounds may contain analgesic properties comparable to mu opioid agonists, while limiting some of their well-known and problematic side effects. In addition, our preclinical research indicates that Delta agonists may be useful for a number of other indications outside the pain area."
Study 33CL230 is a randomized, double-blind, single-dose, active and placebo controlled parallel group study of ADL5859 for the treatment of pain after surgical removal of impacted third molars. The study is expected to enroll approximately 200 subjects. The active control is ibuprofen. The primary endpoint for the study is a measure of pain relief. Adolor anticipates beginning additional proof of concept studies evaluating ADL5859 in other pain indications in the fourth quarter of 2007.
Adolor is also targeting an Investigational New Drug (IND) application filing with the U.S. Food and Drug Administration (FDA) for a second Delta agonist, ADL5747, in the fourth quarter of this year.
Adolor's series of proof of concept studies follows the completion of a single-dose study and a multiple-dose study in Phase 1 in which ADL5859 was evaluated in healthy volunteers.
ADL5859 Phase 1 Program
Results from a recently completed single-dose study and a multiple-dose study with ADL5859, conducted in a total of 50 healthy volunteers, showed good oral bioavailability and a pharmacokinetic profile that may be suitable for once or twice daily dosing. The Phase 1 studies examined single doses up to 300mg and multiple doses up to 120mg twice daily. There were no serious adverse events reported or study discontinuations attributed to adverse events in either of the studies.
About the Delta Receptor Program
One of three opioid receptors, the Delta receptor has potential utility in a variety of indications, including the modulation of pain. Through a proprietary research platform based on cloned, human opioid receptors, Adolor has identified a series of novel, orally active Delta agonists - compounds that selectively stimulate the Delta opioid receptor. Delta compounds may have a number of potential advantages, including an improved side effect profile, as compared to mu opioid receptor agonists. On the basis of preclinical evaluation in animal models of human conditions, one might expect a Delta agonist to show effect in inflammatory pain, among other pain conditions. In addition, Delta agonists are thought to modulate other biological processes that may manifest themselves in disease states or conditions such as cardioprotection, overactive bladder, and depression. There are currently no selective Delta agonists approved by the FDA.
About Adolor Corporation
Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg(R) (alvimopan) is Adolor's lead product candidate under development for the management of the gastrointestinal side effects associated with opioid use. Adolor and GlaxoSmithKline (GSK) are collaborating in the worldwide development and commercialization of Entereg(R) in multiple indications. Adolor also has a number of discovery research programs focused on the identification of novel compounds for the treatment of pain. By applying its knowledge and expertise in pain management, along with ingenuity, Adolor is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit www.adolor.com.
This release, and oral statements made with respect to information contained in this release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that our Delta product candidates ADL5859 and ADL5747 will show adverse safety findings that make them unsuitable for further development; the risk that our Delta product candidates do not show utility in treating pain or any other clinical indications; the risk that we do not initiate further clinical studies for our product candidate ADL5859; the risk that we do not file an IND by the end of this year or at all for our product candidate ADL5747; the risk that filing targets for regulatory filings are not met; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; Adolor's history of operating losses since inception and its need for additional funds to operate its business; Adolor's reliance on its collaborators, including GlaxoSmithKline in connection with the development and commercialization of Entereg(R); market acceptance of Adolor's products, if regulatory approval is achieved; reliance on third party manufacturers; product liability claims; competition; and securities litigation.
Further information about these and other relevant risks and uncertainties may be found in Adolor's Reports on Form 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 in the SEC EDGAR database at http://www.sec.gov and from Adolor at http://www.adolor.com. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Adolor undertakes no obligation to (and expressly disclaims any such 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.
SOURCE: Adolor Corporation