Astra Zeneca abandons TC-5214 regulatory filing as Ph III fails

In what is another pipeline disappointment for the company, Anglo-Swedish drug major AstraZeneca (LSE: AZN) said this morning that, as a result of disappointing efficacy findings in a Phase III study of the depression drug candidate TC-5214, it will not pursue a regulatory filing for the product as a adjunct treatment for patients major depressive disorder (MMD). The drug is partnered with US biopharma firm Targacept (Nasdaq: TRGT).

The companies said that top-line results from the remaining Phase III studies investigating efficacy, tolerability and safety of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who did not respond adequately to initial antidepressant treatment. RENAISSANCE 4 and RENAISSANCE 5, both efficacy and tolerability studies, did not meet the primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) total score after eight weeks of adjunct treatment with TC-5214 as compared to placebo.

TC-5214 was overall well tolerated in RENAISSANCE 4 and RENAISSANCE 5 with an adverse event profile generally consistent with prior clinical trials. In RENAISSANCE 7, a long-term study designed primarily to evaluate the safety of TC-5214 together with an antidepressant treatment, for one year, TC-5214 was overall well tolerated, with an adverse event profile generally consistent with prior clinical trials.