In fresh setback, Targacept drug flunks PhII ADHD study

Just three weeks after reporting that GlaxoSmithKline was dumping its big neuroscience drug development pact, Targacept says one of its other treatments flunked a proof-of-concept study for ADHD. 

Investigators say TC-5619 did not meet the primary efficacy outcome measure: change from baseline on the Conners' Adult ADHD Rating Scale-Investigator Rated Total ADHD Symptoms score after four, eight and 12 weeks of dosing. But the Winston-Salem, NC-based biotech isn't giving up on the drug.

"We continue to pursue a strategy of using initial Phase II development to gain clinical insights that help identify the indications for which our compounds will be best suited for later-stage development," said J. Donald deBethizy, Targacept's president and CEO. "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. Coupled with positive outcomes from our prior Phase II study in patients with schizophrenia on measures of executive function, negative symptoms of schizophrenia and global change, we now have a foundation to guide future development of TC-5619."

Last May, AstraZeneca amended its collaboration deal with Targacept, gaining an option for an exclusive license to TC-5619 the first time it achieves clinical proof of concept--whether in CDS, ADHD or Alzheimer's disease. AZ paid $11 million and promised $30 million more if it exercised its option. If AZ takes the option, it committed to pay up to $212 million in milestones.

- here's the Targacept press release