Targacept Inc announced the successful completion of two randomized, double-blind, placebo-controlled, Phase I clinical trials for its proprietary Neuronal Nicotinic Receptor (NNR) agonist compound TC-1734 in development for the treatment of cognitive and memory disorders. In these studies, no safety issues were noted and encouraging dose-specific, positive effects on direct and surrogate measures of memory and attention were demonstrated.
Additionally, the results of these trials indicate rapid absorption and good dose-proportionality and plasma half-lives, which are all supportive of a once-daily dosing schedule. Targacept is planning to advance TC-1734 into the next phase of clinical evaluation.
"We are very encouraged by the Phase I data as it provides further clinical evidence that NNR-based therapeutics can be dosed safely and at clinically relevant levels. This candidate is part of a portfolio of highly selective, first-in-class therapies that are being developed to treat multiple neuropsychiatric indications. We expect that our rational approach to drug design, selectively targeting NNRs, will enable Targacept scientists to lead the development of a new class of drugs to treat central nervous system diseases. We are excited by the prospects for TC-1734 and look forward to moving this compound to the next phase of clinical development," said Don deBethizy, President and CEO of Targacept.
The first trial was a single rising dose trial conducted in 48 normal healthy volunteers and was designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the clinical candidate over a range of eight escalating doses. The second trial was a multiple rising-dose trial conducted in 24 normal healthy volunteers and was designed to further evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics over a range of three escalating doses. Additionally, a pharmacokinetic study in six elderly volunteers was also completed.
TC-1734 was designed by Targacept scientists using Pentad, the company's powerful proprietary in-silico drug discovery engine for selectively targeting specific CNS receptors, minimizing activity at other receptors that are implicated in side effects and providing drug candidates with superior pharmacokinetic and pharmaceutical properties. In extensive pre-clinical testing, TC-1734 demonstrated long lasting positive effects on memory and learning as well as robust neuroprotective activity.