Arena Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of APD916 for Narcolepsy and Cataplexy
SAN DIEGO, March 24, 2010 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy.
"There is a need for better tolerated, more effective therapies for narcolepsy, especially narcolepsy with cataplexy," said William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "Based upon preclinical data, we believe that APD916 may substantially improve the treatment of these potential orphan indications."
This randomized, double-blind and placebo-controlled Phase 1 trial is planned to enroll up to 72 healthy adult volunteers and will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses of APD916.
APD916, a potent and selective inverse agonist of the histamine H3 receptor, is Arena's internally discovered drug candidate for the treatment of narcolepsy and cataplexy. The histamine H3 receptor is predominantly expressed in the brain, and inverse agonists of the H3 receptor increase the synthesis and release of histamine through inhibition of presynaptic autoreceptors. Enhanced histamine release plays an important role in arousal, and the histaminergic system is at least partly under the control of orexin/hypocretin neurons. Narcolepsy with and without cataplexy have been associated with orexin/hypocretin deficiency and low levels of histamine in cerebrospinal fluid. Therefore, an H3 inverse agonist, by increasing central histamine activity, could be effective in the treatment of these conditions. APD916 was efficacious in multiple preclinical models, and the data suggest APD916 has potential utility in the treatment of narcolepsy with or without cataplexy.
About Narcolepsy and Cataplexy
Narcolepsy is a chronic neurological disorder caused by the brain's inability to regulate sleep-wake cycles normally. At various times throughout the day, people with narcolepsy experience irresistible bouts of sleep. If the urge becomes overwhelming, individuals will fall asleep for periods lasting from a few seconds to several minutes. Cataplexy, or the sudden loss of voluntary muscle tone triggered by emotional factors, is a symptom of narcolepsy and can cause a range of physical changes, from slurred speech to complete weakness of most muscles.
According to the National Institutes of Health, or NIH, narcolepsy is not rare, but it is an underrecognized and underdiagnosed condition. The NIH estimates that narcolepsy affects about one in every 2,000 Americans. Treatments are limited and consist of stimulant drugs to suppress daytime sleepiness and antidepressants for cataplexy. The only approved treatment for cataplexy in the United States is Xyrem (sodium oxybate), a DEA Schedule III drug.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management, including weight loss and maintenance of weight loss, and has completed a pivotal Phase 3 clinical trial program. Arena has filed an NDA for lorcaserin, and the FDA has assigned a PDUFA date of October 22, 2010 for the review of the application.
Arena Pharmaceuticals® and Arena® are registered service marks of the company. "APD" is an abbreviation for Arena Pharmaceuticals Development.
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 development, therapeutic indication and use, tolerability, safety and efficacy of APD916; the potential of APD916 and H3 inverse agonists in general, including the potential to improve treatment; potential of being an orphan indication; the protocol, design, scope, enrollment and other aspects of the Phase 1 program for APD916; the advancement, therapeutic indication, and regulatory review of lorcaserin; and Arena's goals, strategy, research and development 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, regulatory authorities may not find data from Arena's clinical trials and other studies sufficient for regulatory approval; the timing and ability of Arena to receive regulatory approval for its drug candidates; the timing, success and cost of Arena's lorcaserin program and other of its research and development programs; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner Arena or others expect or at all; Arena's ability to enter into agreements to develop or commercialize its compounds or programs; Arena's ability to commercialize lorcaserin with a pharmaceutical company or independently; Arena's ability to obtain adequate funds; 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.
Contact: Arena Pharmaceuticals, Inc. Media Contact: Russo Partners Jack Lief David Schull, President President and CEO firstname.lastname@example.org 212.845.4271 Cindy McGee Manager, IR and Corporate Communications Anthony J. Russo, Ph.D., CEO 858.453.7200, ext. 1479 email@example.com 212.845.4251 www.arenapharm.com
SOURCE Arena Pharmaceuticals, Inc.