Partners AstraZeneca and Targacept confirmed that they won’t be filing for regulatory approval of the latter’s major depressive disorder (MDD) candidate TC-5214, given that the last two of four Phase III studies evaluating the drug failed to meet their primary endpoints. TC-5214 was in development as an adjunct to antidepressant therapy for MDD patients who didn’t respond adequately to SSRI or SNRI inhibitors.
Data from the Renaissance 4 and Renaissance 5 studies have now indicated that treatment of TC-5214 as an adjunct to antidepressant therapy in MDD patients failed to result in improvements, measured as Montgomery-Asberg Depression Rating Scale (MADRS) scores. All four of the Renaissance Studies failed to meet their targets. Data from Renaissance 3 and Renaissnance 2 were reported in November and December 2011, respectively.
Targacept says the potential failure of TC-5214 is something the firm had been preparing for. “Since the readout from the first Renaissance program outcomes, we have been carefully scrutinizing all aspects of our business to prepare for this contingency, and we will announced our plans by the end of April," comments J. Donald deBethizy, Ph.D., president and CEO. “Targacept has built a deep and mechanistically diverse clinical pipeline, and with multiple NNR (neural nicotinic receptor) therapeutics in Phase II development in areas of large medical need and commercial opportunity, and over $225 million in cash, we are well-positioned for future success.”