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Targacept's ADHDi Candidate Fails

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Targacept Inc. recently announced disappointing results from a phase II trial of TC-5619. Targacept is developing the candidate for the treatment of inattentive-predominant attention deficit/hyperactivity disorder (ADHDi).

The TC-5619 phase II double blind, placebo controlled, randomized parallel group study was conducted over 13 sites in the US. The primary objective of the study was to measure the change from baseline, on the inattention subscale, of the Conners’ Adult ADHD Rating Scale-Investigator-Rated (CAARS-INV), which Targacept failed to meet. The result was measured for a four-week period and compared with placebo.

The results from the study revealed that patients on the placebo dose showed more improvement in comparison to patients who were treated with TC-5619.

The study involved a total of 175 patients suffering from ADHDi, out of which 153 completed the study. The study also had a two-week follow-up period.

In 2007, Targacept entered into a licensing agreement with AstraZeneca PLC (AZN - Free Report) for the development of TC-5619. The agreement was amended later in 2010.

We remind investors that Targacept and AstraZeneca were also developing TC-5214 as an adjunct treatment for major depressive disorder (MDD) patients who have not responded adequately to initial antidepressant therapy. In March this year, the companies announced disappointing results from phase III efficacy and tolerability trials evaluating TC-5214.

Following the disappointing results, AstraZeneca and Targacept decided not to file TC-5214 for approval. The agreement was terminated in May this year.

Our Recommendation

We currently have a Neutral recommendation on Targacept. The stock carries a Zacks #3 Rank (Hold rating) in the short run.

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