Arena Pharmaceuticals Announces APD668 Initial Clinical Study Results Suggest Glucose-Dependent Insulinotropic Receptors May Improve Glucose Control in Patients With Type 2 Diabetes
Ortho-McNeil to Continue Investigation of GDIR Agonists Under its Partnership with Arena
SAN DIEGO, Jan 07, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Arena Pharmaceuticals, Inc.
(Nasdaq: ARNA) announced today that initial clinical study results for APD668,
an oral drug candidate discovered by Arena and being investigated for the
treatment of type 2 diabetes under a partnership with Ortho-McNeil
Pharmaceutical, Inc., suggest that Glucose-Dependent Insulinotropic Receptors,
or GDIRs, may improve glucose control in patients with type 2 diabetes.
Ortho-McNeil's initial clinical studies evaluated healthy volunteers and
patients with type 2 diabetes in randomized, double-blind, placebo-controlled
trials evaluating the safety, tolerability, pharmacokinetics and
pharmacodynamics of single and multiple (14 day) escalating doses of APD668.
Based on the data from those studies, Ortho-McNeil has decided to put APD668
on hold and has advanced a potentially more potent Arena discovered GDIR
agonist into preclinical development.
"We are encouraged by the clinical study results supporting GDIR agonists
as effective modulators of glucose homeostasis in patients with type 2
diabetes, and we look forward to the results of Ortho-McNeil advancing another
of Arena's GDIR compounds into development," stated Dominic P. Behan, Ph.D.,
Arena's Senior Vice President and Chief Scientific Officer.
About the Glucose-Dependent Insulinotropic Receptor (GDIR)
The GDIR is an orphan G protein-coupled receptor, or 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. Stimulation
of the GDIR is intended to more efficiently promote insulin release by beta
cells in response to elevated blood glucose levels. In addition, in
preclinical studies, the GDIR stimulates the release of GLP and GIP, two
incretins that are important for proper insulin regulation, which may enhance
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. The GDIR is amenable to small molecule, orally
active, drug development.
Diabetes is a major worldwide disease. Based on 2003 data, the
International Diabetes Federation estimated that in 2005 there were 194
million adults with diabetes worldwide, an increase of over 40% since 1995.
Approximately 90%, or 175 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 $10 billion in 2004, of which oral drugs exceeded $6 billion.
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 targeting G protein-coupled
receptors, an important class of validated drug targets, includes compounds
being evaluated independently and with its partners, Merck & Co., Inc. and
Ortho-McNeil Pharmaceutical, Inc.
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 tolerability, side effects, efficacy
and the potential of Glucose-Dependent Insulinotropic Receptors, or GDIRs,
including the potential to improve glucose control or homeostasis, the further
development of GDIRs, 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, Arena's planned clinical trials and studies may not proceed at the time or
in the manner 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 lorcaserin, APD125, APD791 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 Marie Claire Duch
President and CEO WeissComm Partners
David Walsey 212.301.7228
Director, Corporate Communications
Arena Pharmaceuticals, Inc.
858.453.7200, ext. 1682