SAN DIEGO, March 29 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. announced today updates on its clinical programs for APD356, being developed for the treatment of obesity, and APD125, being developed for the treatment of insomnia.
APD356 (Obesity) Clinical Program Update
Arena recently received results from its chronic twelve and six-month pre-clinical toxicology studies of APD356, its orally administered, internally discovered drug candidate for the treatment of obesity. The toxicology studies did not demonstrate any apparent drug effect on heart valves or pulmonary vasculature, and Arena continues to expect to initiate the APD356 Phase 3 program in the second half of 2006.
“We are very encouraged by the results of these toxicology studies, which provide additional evidence of the favorable safety profile of APD356 emerging from the clinical and pre-clinical data,” commented William Shanahan, M.D., Arena’s Vice President and Chief Medical Officer. “Demonstrating chronic pre-clinical safety is important in the development of any drug.”
An abstract discussing the Phase 2b clinical results of APD356 has been selected for an Oral Presentation at the American Diabetes Association’s 66th Annual Scientific Sessions in Washington, D.C., and is scheduled to be presented on June 12, 2006.
APD125 (Insomnia) Clinical Program Update
Arena also recently received correspondence from the FDA seeking clarification of certain nonclinical issues in its IND application for APD125, which seeks approval to conduct a Phase 2 clinical trial in patients with chronic insomnia. Arena believes that the issues raised by the FDA may be resolvable using available data, but the FDA may require Arena to generate additional data.
If no additional data are required, Arena believes it will be able to initiate the Phase 2 trial around mid-year. If additional data are required, Arena expects the initiation of the trial will be delayed until the fourth quarter of this year. In either event, while the initiation of the Phase 2 trial is subject to the FDA’s further review and allowance, Arena believes that the delay will not affect the company’s longer-term timeline of submitting an NDA in 2009.
“We are committed to expeditiously resolving the FDA’s issues and remain very optimistic about the potential of the APD125 program. The Phase 1 trials provided strong initial evidence of a favorable safety profile and a robust increase in slow wave sleep and other sleep parameters associated with improved sleep maintenance,” stated Dr. Shanahan. “Even if we are ultimately required to submit data that is not currently available, any required studies should be relatively short in duration and should be completed in time for us to initiate the Phase 2 trial later this year.”
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focusing on the discovery, development and commercialization of small molecule drugs in four major therapeutic areas: metabolic, central nervous system, cardiovascular and inflammatory diseases. Arena is developing a broad pipeline of compounds targeting an important class of drug targets called G protein-coupled receptors, or GPCRs, using its knowledge of GPCRs and its technologies, including CART(TM) (Constitutively Activated Receptor Technology) and Melanophore. Arena has four internally discovered, clinical-stage drug candidates for major diseases. The most advanced is APD356, a selective 5-HT2C serotonin receptor agonist that is under investigation for the treatment of obesity and is expected to enter Phase 3 clinical development in the second half of 2006. Arena’s lead drug candidate for the treatment of insomnia, APD125, is a compound with a novel mechanism of action (a selective 5-HT2A receptor inverse agonist) with an IND pending before the FDA for the initiation of a Phase 2 trial in patients with chronic insomnia. Arena also has two clinical-stage collaborations with major pharmaceutical companies: Merck & Co., Inc., began a Phase 1 clinical trial of an Arena-discovered drug candidate for the treatment of atherosclerosis and related disorders in the third quarter of 2005; and Ortho-McNeil, Inc., a Johnson & Johnson company, began a Phase 1 clinical trial of APD668, an Arena-discovered drug candidate for the treatment of type 2 diabetes in the first quarter of 2006.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company. CART(TM) is an unregistered service mark of the company. “APD” is an abbreviation for Arena Pharmaceuticals Development.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the expected clinical trials of APD356 and APD125, the emerging safety profile of APD356, whether the FDA’s comments regarding APD125 are resolvable, and, if so, the time and effort it may require to resolve, the timing of Arena’s expected NDA for APD125, and other statements about Arena’s strategy, technologies, preclinical and internal and partnered clinical programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the FDA may not allow Arena’s planned clinical trials to proceed at the time Arena expects or at all, the results of preclinical studies or clinical trials may not be predictive of future results, Arena’s ability to partner APD356, APD125 or other of its compounds or programs, the timing, success and cost of Arena’s research, out-licensing endeavors and clinical trials, Arena’s ability to obtain additional financing, Arena’s ability to obtain and defend its patents, and the timing and receipt of payments and fees, if any, from Arena’s collaborators. Additional factors that could cause actual results to differ materially from those stated or implied by Arena’s forward-looking statements are disclosed in Arena’s filings with the Securities and Exchange Commission. These forward-looking statements represent Arena’s judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Contacts: Jack Lief Media: President and CEO Carin Canale Porter Novelli Life Sciences David Walsey 858.527.3498 Director, Corporate Communications Arena Pharmaceuticals, Inc. 858.453.7200, ext. 1682
Arena Pharmaceuticals, Inc.
CONTACT: Jack Lief, President and CEO, or David Walsey, Director,Corporate Communications, both of Arena Pharmaceuticals, Inc.,+1-858-453-7200 ext. 1682; or Media, Carin Canale of Porter Novelli LifeSciences, +1-858-527-3498, for Arena Pharmaceuticals, Inc.
Web site: http://www.arenapharm.com/
