Athenagen Announces Publication Of Results From A Proof-of-Concept Trial Of Its Novel Alpha-7 Nicotinic Receptor Agonist In Schizophrenia

Main Category: Schizophrenia
Also Included In: Clinical Trials / Drug Trials
Article Date: 16 Jun 2006 - 0:00 PDT

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Athenagen, Inc., a privately held biopharmaceutical company, reported today that its lead compound, GTS-21, a novel, orally active alpha-7 nicotinic acetylcholine (nACh) receptor agonist, demonstrated cognition enhancement activity in a proof-of-concept study in patients with schizophrenia. The study was published in the June issue of the Archives of General Psychiatry (2006; 63:630-638), a peer-reviewed publication of the American Medical Association.

The NIH-funded study was conducted by Dr. Robert Freedman, Professor and Chairman of the Department of Psychiatry at the University of Colorado Health Sciences Center. Patients were randomized into a double-blind crossover trial of two drug doses and one placebo arm. Significant neurocognitive improvement was found on the Repeatable Battery for the Assessment of Neuropsychological Status total scale score, particularly for the lower dose, compared with placebo. Significant improvement in P50 inhibition also occurred and the drug was generally well tolerated.

"We are encouraged by these data demonstrating utility of GTS-21 for cognition enhancement in schizophrenia," stated Henry Hsu, M.D., Chief Medical Officer of Athenagen. "Taken together with Phase 1 data demonstrating safety and also cognition enhancement in healthy volunteers, we intend to further study GTS-21 in diseases associated with cognitive deficiency, such as Alzheimer's disease, Mild Cognitive Impairment, and Attention Deficit Hyperactivity Disorder."

About GTS-21

GTS-21 (also known as DMBX-A), is a novel, small-molecule, orally active and selective alpha-7 nicotinic acetylcholine (nACh) receptor agonist that has demonstrated memory and cognition enhancement activity in human clinical trials. Athenagen licensed the exclusive rights to the compound and a related library of analogs as part of the acquisition of Osprey Pharmaceutical Company in April 2006. GTS-21 has been studied in multiple Phase I studies in healthy volunteers and one Phase I/II study in schizophrenic patients. In all studies, the compound was well tolerated. In a Phase I multi-dose, double-blind, placebo controlled study in healthy adults, GTS-21 also demonstrated cognitive enhancement across all doses, with a statistically significant improvement in attention related and memory related tasks (Kitagawa, et al. Neuropsychopharmacology (2003), 28, 542-551).

About Athenagen

Athenagen, Inc., located in South San Francisco, is engaged in the development of small-molecule drugs that act on the nicotinic acetylcholine (nACh) receptor pathway. The company's lead nACh receptor agonists and antagonists are being developed to treat diseases associated with enhanced or impaired angiogenesis and to treat diseases in which cognitive deficit plays a significant role. Athenagen currently has three product development programs acting on this pathway: ATG003, a topical (eye drop) anti-angiogenesis compound for neovascular AMD; ATG002, a topical (gel) pro-angiogenesis compound for diabetic foot ulcers; and GTS-21, an oral nACh receptor agonist for cognition enhancement. For more information:

Athenagen, Inc.
http://www.athenagen.com

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