Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of separate Phase 2 clinical studies of its product candidate TC-6987 in disorders characterized by inflammation, one in asthma and one in Type 2 diabetes. TC-6987 is a modulator of the alpha7 neuronal nicotinic receptor and was discovered by Targacept scientists using Pentad™, the company's proprietary drug discovery platform.
A large body of scientific evidence highlights the key role that the alpha7 receptor plays in pathways mediated by pro-inflammatory molecules known as cytokines, and published studies suggest that alpha7 modulation modifies the inflammatory response by inhibiting cytokine production and release. TC-6987 demonstrated a potent anti-inflammatory response in a variety of preclinical studies conducted by Targacept, including models of asthma and diabetes, and was generally well tolerated in Phase 1 clinical trials. The Phase 2 studies are planned to provide valuable insights to guide the selection of the therapeutic indications for which TC-6987 is best suited for later-stage development. The statistical analyses for both of these learning trials will be based on one-sided testing performed at the p < 0.10 level of significance.
"The alpha7 nicotinic receptor subtype occupies a critical position in regulating the severity of inflammation, and, as such, represents a promising target for development of much needed new treatments for debilitating inflammatory and autoimmune diseases," said Kevin J. Tracey, M.D., Director and Chief Executive of The Feinstein Institute for Medical Research.
"We are pleased to diversify our therapeutic focus further with our first studies in inflammatory disorders, highlighting the sustainability of our pipeline fueled by our proprietary drug discovery platform," said J. Donald deBethizy, Ph.D., Targacept's President and Chief Executive Officer. "The preclinical and early clinical profile of TC-6987, coupled with the well-established role of alpha7 in cytokine-mediated inflammation, suggests the potential of this product candidate to benefit patients who suffer from the serious effects of inflammatory disorders and the limitations of current therapies."
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