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Arena Pharmaceuticals Announces Initiation of Phase 2b Clinical Trial of Its Novel Anti-Obesity Compound

Posted on: Thursday, 23 June 2005, 09:00 CDT

SAN DIEGO, June 23 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. announced today that it started dosing patients in a Phase 2b clinical trial of APD356, Arena's orally administered, internally discovered drug candidate for the treatment of obesity. The trial will evaluate safety and weight loss in approximately 400 obese patients over 12 weeks. In a Phase 2a clinical trial, APD356 demonstrated a highly statistically significant (p=.0002) average weight loss of 2.9 pounds in patients taking the 15 mg dose of APD356 versus 0.7 pounds for the placebo group, and was generally well tolerated at all doses investigated.

The Phase 2b clinical trial is a randomized, double-blinded, dose-ranging study being conducted in the United States. Approximately 400 obese patients will be randomized into four groups to evaluate the safety and efficacy of orally administered doses of 10 mg once daily, 15 mg once daily, and 10 mg twice daily (before breakfast and dinner) of APD356 compared to placebo for 12 weeks. The dose of 10 mg twice daily is expected to provide similar peak blood levels as the 15 mg once daily dose, but higher blood trough levels, thereby maintaining higher average drug concentrations in the blood. The second dose will also provide a second peak in drug level to cover the evening hours. In addition to standard safety evaluations, patients will be assessed by echocardiogram prior to enrollment and at the end of the treatment period. Patients will not receive any diet or exercise advice, but will be required to abstain from consuming alcohol. With the exception of the length of the trial, the design of this trial is substantially similar to the design of the four-week Phase 2a study.

"We are excited to initiate this Phase 2b trial, especially in light of the positive Phase 2a results we recently reported, and we look forward to reporting the preliminary results from the trial around the end of the year," stated Jack Lief, Arena's President and CEO. "We are also looking forward to soon announcing initial safety and efficacy data from our Phase 1 clinical trials of APD125 for insomnia. In addition to these clinical-stage programs, we are working aggressively to advance other development programs while continuing our partnering efforts."

About Obesity

Obesity affects tens of millions of adults and children in the U.S. and poses a serious long-term threat to their health and welfare. The number of overweight and obese people has substantially increased over the past several decades. Approximately two-thirds of all adults in the U.S. are obese or overweight. Medical and related costs of obesity in the U.S. were more than $117 billion in 2000. Being obese or overweight is associated with a number of conditions, including heart disease, stroke, diabetes, cancer and osteoarthritis. Medical treatment options for obese and overweight people are currently limited.

About APD356

APD356 is a selective agonist of 5-HT2C serotonin receptors, which are located in the hypothalamus, an area of the brain that plays an important role in regulating food intake and metabolism. Discovered by Arena, APD356 is intended to selectively stimulate the 5-HT2C receptor and has approximately 100-fold selectivity in vitro for the 5-HT2C receptor relative to the 5-HT2B receptor. It is hypothesized that activation of the 5-HT2B receptor is associated with the cardiac valvulopathy observed with non-selective serotonergic agents. In addition, APD356 has approximately 15-fold selectivity in vitro for the 5-HT2C receptor versus the 5-HT2A receptor. Arena believes that the 5-HT2A receptor contributes to the potential central nervous system adverse effects associated with non-selective serotonergic agents. Arena expects that the selectivity of APD356 may allow the compound to be dosed at a well-tolerated level that will induce clinically relevant weight loss without the cardiac valvular side effects observed with non-selective serotonergic agents previously used in the treatment of obesity.

Arena holds a patent entitled "5-HT2C Receptor Modulators" granted by the European Patent Office relating to novel compounds that modulate the 5-HT2C serotonin receptor. APD356 is covered under the patent. Arena has a similar patent pending in the U.S. and elsewhere.

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, cardiovascular, inflammatory and central nervous system diseases. Arena is developing a broad pipeline of compounds that act on an important class of drug targets called G protein-coupled receptors, or GPCRs, using its proprietary technologies, including CART(TM) (Constitutively Activated Receptor Technology) and Melanophore. Arena's most advanced clinical compound, APD356, a selective 5-HT2C serotonin receptor agonist for the treatment of obesity, is in Phase 2. Arena is also conducting Phase 1 clinical trials on APD125, a compound with a novel mechanism of action (a selective 5-HT2A receptor antagonist) for the treatment of insomnia. Arena has active collaborations with two major pharmaceutical companies, Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson company, for the treatment of type 2 diabetes, and Merck & Co., Inc., for the treatment of atherosclerosis and related disorders.

Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company. CART(TM) is an unregistered service mark of the company.

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 Arena's Phase 2b clinical trial of APD356, including the design and implementation of the trial and expected activities therein, the timing of results from Arena's clinical trials, the effects of administration of APD356, including the expected effects of specific doses of APD356 and APD356's potency, pharmaceutical behavior and expected blood levels, and other statements about Arena's strategy, technologies, preclinical and clinical programs, and ability to develop compounds and commercializing 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 risk that the results of preclinical or clinical trials may not be predictive of future results, Arena's ability to partner APD356, the results of the Phase 2b study and any future studies of APD356, the results of echocardiograms, the timing, success and cost of Arena's research, out-licensing endeavors and clinical studies, Arena's ability to obtain additional financing, and the timing and receipt of payments and fees, if any, from Arena's collaborators, including Ortho-McNeil and Merck. 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 President and CEO David Walsey Director, Corporate Communications Arena Pharmaceuticals (858) 453-7200, ext. 1682 Susan Neath Atkins + Associates Media & Investor Relations (858) 527-3486 http://www.arenapharm.com/

Arena Pharmaceuticals, Inc.

CONTACT: Jack Lief, President and CEO, or David Walsey, Director,Corporate Communications, both of Arena Pharmaceuticals, +1-858-453-7200,ext. 1682; or Media & Investor Relations, Susan Neath of Atkins + Associates,+1-858-527-3486

Web site: http://www.arenapharm.com/

Source: PRNewswire-FirstCall

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