Targacept stock was 11% down yesterday at close after the firm confirmed that the failure of its TC-5619 drug candidate in a Phase II attention deficit hyperactivity disorder (ADHD) trial will mean job losses and a squeeze on investment in other pipeline projects. Targacept yesterday reported disappointing topline data from a Phase II study evaluating TC-5619 in 175 patients with inattentive-predominant ADHD (ADHDi). The placebo-controlled study in 175 adult patients failed to meet its primary outcome measure of change from baseline on the inattention subscale of the Connors’ Adult ADHD Rating Scale-Investigator-Rated, after four weeks of treatment.
The firm says it will now drop further development of the drug for the ADHDi indication. “We are disappointed that TC-5619 did not meet our goal in this ADHDi study,” comments Mark Skaletsky, board chairman. “Under these circumstances, we are taking additional steps to more closely align our resources with our current operational plan and emphasize the efficient use of Targacept’s capital. We will limit our investment in our nicotinic pipeline to our ongoing or previously announced clinical programs until the search for a new CEO is successfully completed, and we will implement a further reduction in force.”
Targacept is focused on the discovery and development of neuronal nicotinic receptor (NNR) modulators for the treatment of nervous system disorders, including schizophrenia, Alzheimer’s disease, and overactive bladder. Lead in-house candidate, TC-5619, which targets alpha7 neuronal nicotinic receptors, is separately in Phase II development for treating negative symptoms and cognitive dysfunction in schizophrenia patients, and is also in early clinical development as a potential treatment for Alzheimer’s disease.