An experimental attention deficit-hyperactivity disorder (ADHD) drug being developed by Targacept in partnership with AstraZeneca (NYSE:AZN) has failed to hit targets set for a mid-stage clinical trial.
Winston-Salem, North Carolina-based Targacept, (NASDAQ:TRGT) said results from a phase 2 proof-of-concept trial for the TC-5619 showed that although patients experienced no adverse effects from the compound, the compound did not meet measures showing efficacy. But TC-5619, which is also being studied for treatment of cognitive dysfunction in patients with schizophrenia, showed positive results for that indication in results of a separate phase 2 study released in January.
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Targacept President and CEO J. Donald deBethizy said in a prepared statement that the company will continue to evaluate data from the clinical research to determine which indications the compound is best suited for targeting in later-stage development.
“While we did not see stimulant-like efficacy in this learning trial, the overall findings provide additional evidence that TC-5619 is active in a cognitively impaired patient population, with the safety results adding to an impressive profile for a compound that has now been studied in more than 200 subjects,” he said.
TC-5619 is being studied under a collaboration between Targacept and AstraZeneca that dates to 2005, when the companies struck a deal to study several Targacept compounds for treating cognitive disorders. The agreement gives AstraZeneca the right to license TC-5619, which would trigger a $30 million payment to Targacept. At that point, AstraZeneca would be responsible for funding development and commercialization of the compound. Targacept could gain additional payments up to $212 million if the compound hits development, regulatory and commercialization milestones.
Targacept said more detailed results of the ADHD trial will be presented at a future scientific meeting. An AstraZeneca decision on whether to license TC-5619 is expected in the second quarter.
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