Targacept Inc.'s (TRGT) neuronal nicotinic receptor or NNR Therapeutics, a new class of drugs for the treatment of central nervous system diseases and disorders, have demonstrated antidepressant effects for the second time in a clinical trial.
The company's investigational TC-5214, which is a broad spectrum NNR antagonist, has successfully achieved primary and secondary goals in a phase IIb study as an augmentation treatment for major depressive disorder. The drug was tested as an add-on treatment for major depressive disorder, or MDD, in subjects who did not respond adequately to first-line treatment with citalopram alone -- the widely-used antidepressant.
The mean change between treatment (TC-5214 + citalopram) and placebo (placebo + citalopram) from baseline was the primary trial goal and it was measured on the Hamilton Rating Scale for Depression-17, or HAM-D. The secondary efficacy measures, included assessments of depression, irritability, disability, cognition, severity of illness and global improvement.
Targacept is actively in search of a strategic partner to assist in the global development and planned commercialization of TC-5214. The company expects late-stage trial of the drug to be initiated in the second quarter of 2010, following planned discussions with FDA.
The company believes that the phase IIb augmentation trial results support the potential of TC-5214 to provide the much needed help for the millions of depressed patients who do not respond adequately to currently available therapies.
According to The National Institute of Mental Health, or NIMH, major depressive disorder is the leading cause of disability in the United States for people between the ages 15 and 44. About 14.8 million American adults are estimated to suffer from this disorder.
TRGT, which has thus far hit a 52-week low of $1.40 and a $52-week high of $10.11, closed Tuesday's regular trading session at $3.06.
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