Winston-Salem, NC Oct 01, 2002
Targacept, Inc. today announced that it has successfully completed Phase I clinical trials to evaluate the tolerability, safety and preliminary pharmacokinetics of TC-2403-12, a neuronal nicotinic receptor agonist derived from Targacept’s library of compounds. The company conducted the clinical trials in collaboration with Dr. Falk Pharma, GmbH of Freiburg, Germany.
Targacept and Dr. Falk formed an alliance in 2001 to develop a new class of drugs to treat ulcerative colitis, a relapsing and remitting disease that affects the innermost lining of the colon. The disease causes numerous debilitating effects on the gastrointestinal system. Symptoms of ulcerative colitis may include abdominal pain, diarrhea, fatigue, loss of appetite and loss of body fluids and nutrients. The disease affects nearly one million people in the United States and Europe.
No significant tolerability or safety concerns were suggested by either the single rising dose study or the 14-day multiple rising dose study of TC-2403-12 dosed in an enema formulation to healthy volunteers. A Phase II placebo-controlled, dose-range-finding trial for proof of therapeutic concept is planned to start in the United States in early 2003. An oral, delayed release formulation of TC-2403-12 is in active development.
“This compound has the potential to become the first new class of drug in the past 50 years targeted to treat ulcerative colitis,” said J. Donald deBethizy, Ph.D., President and CEO of Targacept. “There is tremendous need for a new treatment to help ulcerative colitis patients achieve a better quality of life.”
TC-2403-12 is one of a new class of drugs that selectively modulates therapeutic targets in the human body known as neuronal nicotinic receptors (NNRs). These receptors maintain and adjust nervous system activity and have been associated with many chronic, debilitating diseases, such as ulcerative colitis.
“We know from the scientific literature that nicotine has therapeutic effects in people with ulcerative colitis but is not well tolerated due to side effects,” said Geoffrey Dunbar, M.D., Vice President of Clinical Development and Regulatory Affairs for Targacept. “By designing a new drug that targets only the NNRs that are relevant to this specific disease, we expect to reduce or eliminate side effects.”
Dr. deBethizy will provide information about Targacept and discuss results of the Phase I studies of TC-2403-12 at the UBS Warburg Global Healthcare Services Conference on Monday, October 7, 2002 at 11:30 a.m. EDT. The presentation will take place at the Plaza Hotel in New York City. The conference’s audio webcast will be available at http://www.ubswarburg.com.
About Targacept
Targacept, Inc. is a world leader in the discovery and development of neuronal nicotinic receptor-based therapies for neurodegenerative, neuropsychiatric and gastrointestinal diseases. The company has products in research and development for treating Alzheimer's disease, Parkinson's disease, Lewy body dementia, ulcerative colitis, depression, pain, anxiety disorders and schizophrenia. Targacept recently acquired the marketed drug Inversine® (mecamylamine HCl), a known modulator of nicotinic acetylcholine receptors. Targacept intends to reformulate mecamylamine HCl for clinical testing in patients with various neuropsychiatric disorders.
Targacept was established in 1997 as a wholly owned subsidiary of R.J. Reynolds Tobacco Company. It was spun out as an independent company in August 2000, in one of the largest ($30.4 million) first-round venture capital financings in U.S. biotech history. The company has strategic alliances with Aventis Pharma SA of Strasbourg, France and Dr. Falk Pharma GmbH of Freiburg, Germany to develop and commercialize Targacept compounds.
Inversine® is a registered trademark of Targacept, Inc.