SAN DIEGO, Dec. 15 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that Ortho-McNeil-Janssen Pharmaceuticals, Inc. (Ortho-McNeil) initiated under their partnership a first-in-human Phase 1 clinical trial of APD597, a novel oral drug candidate discovered by Arena that targets the glucose-dependent insulinotropic receptor (GDIR) for the treatment of type 2 diabetes. The GDIR was also discovered by Arena and has the potential to stimulate insulin release in response to increases in blood glucose.
"The GDIR is a promising and exciting target for the treatment of type 2 diabetes. We look forward to continuing to work with Ortho-McNeil on APD597 as it advances in the clinic," stated Jack Lief, Arena's President and Chief Executive Officer.
Ortho-McNeil's Phase 1 program will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of APD597 in single and multiple ascending dose studies in healthy volunteers. Ortho-McNeil's planned clinical studies will also include the evaluation of patients with type 2 diabetes.
About the Glucose-Dependent Insulinotropic Receptor (GDIR)
The GDIR is an orphan G protein-coupled receptor (GPCR), discovered by Arena. It is expressed in beta cells, the cells in the pancreas responsible for producing insulin in response to increases in blood glucose. The GDIR signals through a similar intracellular pathway as the GLP-1 receptor, with common downstream effects, but unlike the GLP-1 receptor, the GDIR has proven amenable to small molecule drug discovery. Stimulation of the GDIR is intended to more efficiently promote insulin release by beta cells in response to elevated blood glucose levels. In addition, the GDIR is expressed in cells other than pancreatic beta cells, such as endocrine cells in the gastrointestinal tract, and in preclinical studies the GDIR stimulates the release of GLP and GIP, two incretins that play an important role in insulin regulation and glucose homeostasis. GDIR stimulation has also been found to increase the levels and activity of intracellular factors thought to be involved in the preservation of beta cells, and GDIR signaling may therefore also serve to maintain beta cell mass in type 2 diabetes.
Diabetes is a major worldwide disease. The International Diabetes Federation estimates that in 2007 there were 246 million adults with diabetes worldwide, an increase of over 20% since 2003. Approximately 90%, or 221 million, of diabetics worldwide suffer from type 2 diabetes, the adult-onset form of the disease. Type 2 diabetes is characterized by inadequate response to insulin or inadequate secretion of insulin as blood glucose levels rise. Therapies for type 2 diabetes are directed toward correcting the body's inadequate response with oral or injectable medications, or directly modifying insulin levels by injection of insulin or insulin analogs.
The worldwide market for diabetes medications exceeded $12 billion in 2005, of which oral drugs exceeded $7 billion. Current oral medications for type 2 diabetes have limitations including side effects and safety issues prompting continued efforts to develop therapeutics to improve the treatment of diabetes.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for the treatment of obesity. Arena's broad pipeline of novel compounds target G protein-coupled receptors, an important class of validated drug targets, and includes compounds being evaluated independently and with partners, including Merck & Co., Inc. and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Arena Pharmaceuticals(R) and Arena(R) 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 APD597's development, therapeutic indication, efficacy and potential; the potential of the GDIR, including the potential to stimulate insulin release in response to increases in blood glucose; future activities under Arena's collaboration with Ortho-McNeil; the protocol, design, scope, enrollment and other aspects of the Phase 1 program for APD597; the inclusion of the evaluation of patients with type 2 diabetes in the planned clinical studies; and about Arena's strategy, internal and partnered 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, clinical trials and studies may not proceed at the time or in the manner Arena expects or at all, the results of clinical trials or preclinical studies may not be predictive of future results, Arena's ability to receive regulatory approval for its drug candidates, Arena's ability to partner lorcaserin 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 Mary Claire Duch President and CEO WeissComm Partners Media Relations David Walsey 212.301.7228 Director, Corporate Communications Arena Pharmaceuticals, Inc. 858.453.7200, ext. 1682
SOURCE Arena Pharmaceuticals, Inc.