Targacept Inc. said yesterday that it has received positive results in the Phase 2b clinical trial of its drug TC-5214 as an augmentation therapy for major depressive disorder.
The drug was given to 265 patients who did not respond adequately to first-line treatment with citalopram, a common antidepressant. The brand name for citalopram is Celexa.
Half of the subjects were treated with TC-5214 and citalopram, and the other half received a placebo and citalopram.
Targacept, which is based in Winston-Salem, said that at the end of the trial, doctors concluded that people on TC-5214 and citalopram were dramatically better than the people who were taking citalopram and a placebo. The results showed that TC-5214 helped improve all of the trial's secondary efficacy measures, including irritability and cognition.
"We are very excited about this data," said J. Donald deBethizy, the president and chief executive of Targacept. "This is a big deal for Winston-Salem. It's a big deal for Targacept. We've been waiting for something this significant to happen to our company."
Targacept's stock price rose $4.19, or 136.9 percent, yesterday to $7.25 a share.
Dr. Madhukar H. Trivedi, one of the principal investigators for the trial, said that the magnitude and consistency of the effect of TC-5214 in this trial could represent a breakthrough for patients with depression.
"It is particularly compelling that the superiority of TC-5214 as augmentation to citalopram over citalopram alone was first seen after only two weeks and grew steadily over the trial's last six weeks, culminating in remission for twice as many subjects in the TC-5214 group," Trivedi said.
Trivedi is a professor and the director of the Mood Disorders Research Program and Clinic at the University of Texas Southwestern Medical Center at Dallas. He is a co-principal investigator in the National Institute of Mental Health's large-scale STAR*D study.
Detailed results from the Phase 2b trial of TC-5214 will be presented in October at the Society for Neuroscience meeting in Chicago.
Targacept said it is in discussions with pharmaceutical companies to find a business partner to help it develop and commercialize TC-5214 worldwide. The company expects to start Phase 3 clinical development in the second quarter of 2010, after discussions with the Food and Drug Administration and production of clinical trial material.
The results of the clinical trial represent the second bit of positive news for Targacept in a week.
Targacept, based in Piedmont Triad Research Park, last week announced that it had received a $10 million milestone payment from its top partner, AstraZeneca PLC, for research in adult attention deficit/hyperactivity disorder.
■ Fran Daniel can be reached at 727-7366 or at fdaniel@wsjournal.com.
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