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Targacept Unveils Stellar Depression Drug Data: BioBuzz

WINSTON-SALEM, N.C. (TheStreet) -- There are times when clinical data crosses the wire and you do a double take, not quite believing what you're seeing.

Last night, after Targacept (TRGT) announced the data from its phase II study of TC-5214, was one of those times.

Depression patients treated with the combination of TC-5214 plus Celexa (marketed by Forest Labs (FRX)) demonstrated a 6-point improvement on the Hamilton Rating Scale for Depression, or HAM-D, compared to patients treated with Celexa alone.

A reporter from a Winston-Salem newspaper emailed me last night to get my impression of this result. The only thing I could think to respond back with was, "Holy $%@!! That's kick-a-- good!"

As I wrote last week in a preview note on the TC-5214 data, investor expectations going into Thursday night's data presentation in Chicago were high, but not 6-points-on-the-HAM-D high. I think people would have been happy with anything greater than a 2-3 point improvement.

TC-5214 hit all the secondary endpoints of the study, too, including the Montgomery-Asberg Depression Rating Scale, or MADRS, where TC-5214 plus Celexa demonstrated a greater than seven-point improvement over Celexa alone.

The safety and tolerability of TC-5214 was clean, with resolvable adverse event rates of nausea, constipation and dizziness in the single digits.

This is a phase II study, so TC-5214 still has to prove itself in large phase III studies, but right now, Targacept's drug looks a lot better than Bristol-Myers Squibb's (BMY) Abilify, which received an expanded FDA approval as an add-on treatment to anti-depressant therapy in late 2007.

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