Addrenex Pharmaceuticals Initiates Phase 2 Trial On Its Novel Hypertension Drug, ADX415

Main Category: Hypertension
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 24 Oct 2008 - 0:00 PDT

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Addrenex Pharmaceuticals 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.

Addrenex Pharmaceuticals
http://www.addrenex.com