Addrenex Pharmaceuticals Initiates Phase 2 Trial on Its Novel Hypertension Drug,...

Addrenex Pharmaceuticals Initiates Phase 2 Trial on Its Novel Hypertension
Drug, ADX415
New drug is company's third to enter human trials in 2 years

DURHAM, N.C., Oct. 23 /PRNewswire/ -- Addrenex Pharmaceuticals today
announced that the U.S. Food and Drug Administration has approved its
Investigational New Drug Application (IND) for ADX415, a novel hypertension
drug. With the approval, Addrenex has launched a phase 2 clinical trial to
study ADX415 as a targeted therapy for hypertension.
The phase 2 trial is a multicenter, double-blind, placebo-controlled,
dose-ranging study that will involve 80 patients. ADX415 is a novel, patented,
centrally acting, alpha-adrenergic receptor agonist specific to alpha-2
receptors.
ADX415 is the company's third drug to receive IND approval and enter human
trials in a 2-year period, continuing the rapid pace of drug development at
Addrenex. ADX415 was identified from an extensive library of alpha-2
adrenergic compounds that Addrenex licensed from the University of Nebraska
Medical Center and that originated from Procter & Gamble Pharmaceuticals.
The scientific focus of Addrenex is the treatment of medical conditions
that arise from an overactive or improperly regulated adrenergic system, a
group of hormones produced by the adrenal glands that regulates diverse
physiologic functions such as blood pressure, heart rate and response to
stress.
"Numerous medical conditions arise from an overactive adrenergic nervous
system, yet few drugs are available that specifically target this complex
pathway," said Moise Khayrallah, cofounder and chief executive officer of
Addrenex. "We built our company to address a wide range of conditions whose
symptoms are not fully managed by drugs currently on the market. Our
scientific team continues to identify and analyze alpha-2 compounds that could
potentially address the unmet needs of patients across a wide range of
conditions."
The company's first two drug candidates are Clonicel to treat attention
deficit hyperactivity disorder (ADHD) and CloniBID to treat hypertension.
Clonicel is currently in phase 3 trials, and a new drug application has been
filed for CloniBID with FDA review expected by the end of the year. Commercial
rights to both drugs, and to ADX415, have been granted to Atlanta-based Sciele
Pharma, a Shionogi Company.
About Addrenex Pharmaceuticals, Inc.
Addrenex Pharmaceuticals is a focused specialty pharmaceutical company
that develops and commercializes drugs to treat adrenergic dysregulation.
Addrenex Pharmaceuticals is based in Durham, N.C., on the edge of Research
Triangle Park. The company was formed in 2006 by a practicing physician and a
drug development expert with the mission to explore the impact that
neurotransmitter regulation has on a variety of diseases and disorders.
Addrenex identified adrenergic regulation as its initial research focus.
Adrenergic dysregulation is implicated in medical conditions such as
hypertension, ADHD, migraines and postmenopausal symptoms. Addrenex will use
the knowledge and experience gained from developing CloniBID and Clonicel as
the foundation for additional discovery and development in the area of
adrenergic regulation.
SOURCE Addrenex Pharmaceuticals

Becky Levine, +1-919-786-4918 x137, blevine@medthink.com, for Addrenex
Pharmaceuticals