News Room

Targacept Reports Positive Phase 2 Data on Ispronicline, a Novel Small Molecule Being Developed for Treatment of Alzheimer’s Disease and Age Associated Memory Impairment

Winston-Salem, NC Jul 06, 2005

Targacept, Inc., a central nervous system-focused biopharmaceutical company, announced today that it presented clinical research results of ispronicline (TC-1734) at the 8th World Congress of Biological Psychiatry in Vienna, Austria on July 2, 2005.  The poster presentation entitled “Cognitive Enhancement in AAMI following Treatment with Ispronicline (TC-1734)” was made by Geoffrey C. Dunbar, M.D., Targacept’s Vice President, Clinical Development and Regulatory Affairs. 

Dr. Dunbar’s presentation included results from placebo-controlled clinical studies in which elderly subjects dosed with 80mg or 50mg of ispronicline performed better on certain memory and attention measures than elderly subjects dosed with placebo.  This improved performance continued well beyond the time that ispronicline was eliminated from the body.  “This separation between kinetic and dynamic effects is of great interest to us, and the fact that these positive effects were associated with low dose levels is very encouraging for ispronicline’s future development for treating conditions of cognitive impairment in the elderly,” said Dr. Dunbar. 

Targacept also reported that it has completed more than 50% of its target enrollment of 180 elderly subjects for its ongoing Phase 2 efficacy trial of ispronicline in age associated memory impairment (AAMI).  This clinical trial is designed as a double-blind, randomized comparison of two doses of ispronicline to placebo over a 16-week treatment period.  The trial is being conducted at 16 clinical sites in the United States.  Targacept is also preparing for a Phase 2 study of ispronicline in patients with mild to moderate Alzheimer’s disease (AD).  The AD study is scheduled to begin in the first half of 2006.  In six completed clinical trials with a total of 200 subjects, ispronicline has been well tolerated and has demonstrated cognitive-enhancing effect.
    
“We were delighted to present clinical data that validate the cognitive-enhancing potential of ispronicline,” said J. Donald deBethizy, Targacept’s President and Chief Executive Officer.  “We are also very pleased with the performance and enthusiasm of the investigational sites for our ongoing Phase 2 AAMI trial.  We are very focused on the continued development of ispronicline and its potential for treating, and slowing the progression of, neurodegenerative diseases such as Alzheimer’s disease.  We recognize the significant need for new treatment options in this area of major unmet medical need.”  

Ispronicline was developed using Targacept’s proprietary rational drug design technology known as Pentad to target specific neuronal nicotinic acetylcholine receptors (NNRs). NNRs have been validated as key regulators of central nervous system functions such as attention, vigilance, memory and mood.

About Targacept
Targacept is a biopharmaceutical company engaged in the design, discovery and development of a new class of drugs to treat multiple diseases and disorders of the central nervous system by selectively targeting neuronal nicotinic acetylcholine receptors, or NNRs.  NNRs are found on nerve cells throughout the nervous system and serve as key regulators of nervous system activity.  Targacept’s product candidates are designed to selectively target specific NNR subtypes to promote therapeutic effects and limit adverse side effects.  Targacept has a marketed product, Inversine(R) (mecamylamine hydrochloride), product candidates in clinical development for cognitive impairment, including Alzheimer’s disease and age associated memory impairment, pain and depression, and multiple ongoing preclinical programs.

Contacts:

Alan Musso, VP and CFO
Targacept, Inc.
Tel: (336) 480-2186 
Email: alan.musso@targacept.com

Michelle Linn
Linnden Communications
Tel: (508) 869-0138
Email: michlinn@charter.net