Using Early-stage Results in Later-stage Development
Keith Wesnes, Ph.D., chief executive of Cognitive Drug Research (CDR; www.cognitivedrugresearch.com) sees translational medicine as identifying information at one stage of drug development that can affect selection of a candidate at a later stage.
CDR has a battery of computerized tests that assess the effect of a potential drug on cognitive functioning in Phase I and beyond. This can give an early indication of a compound’s efficacy, as well as its safety.
Dr. Wesnes developed a model in which injection of the drug scopolamine into healthy volunteers temporarily produces the cognitive deficits of Alzheimer’s disease and related conditions. This model has been widely used for evidence of safety and efficacy of drugs in Phase I. “It can provide early evidence that a compound is doing what it is supposed to, which is an important aspect of translational medicine,” he says.
CDR has also developed a sleep deprivation model, which is applicable to Phase I testing of drugs for sleep disorders, including sleep apnea, narcolepsy, and shift work sleep disorder. The CDR approach is being used to test new classes of drugs, such as nicotinic agonists, for their cognitive enhancing properties.
This model has led to promising Phase II results on a drug in this class being researched through a collaboration between Targacept (www.targacept.com) and AstraZeneca for age-associated memory impairment. The CDR battery of cognitive tests has also been used in a recent Phase I study of a nicotinic agonist from Memory Pharmaceuticals (www.memorypharma.com).
The company’s approach is also proving valuable in testing the next generation of psychiatric drugs for any residual cognitive effects which can otherwise impair the patient’s everyday functioning. “Companies feel this all adds value for they can enter Phase II knowing much more about their products, which helps attract partnerships and new investment,” points out Dr. Wesnes.