More good news for Targacept: the company has announced favorable results from a Phase II trial of TC-5214 as an add-on treatment for major depressive disorder in subjects who did not respond to first-line treatment with Forest Labs' Celexa alone.
Patients given TC-5214 with Celexa experienced an improvement in their depression rating scores verses those taking just Celexa. Favorable results were also reported for secondary efficacy measures, including assessments of depression, irritability, disability, cognition, severity of illness and global improvement. Side effects included headache, dizziness and constipation, though these did not cause a significant difference between the dose groups in discontinuations due to adverse events. Only one serious adverse event was reported; a seizure experienced by a study subject. Further results will be presented at the Society for Neuroscience meeting scheduled for October 2009.
"The magnitude and consistency of the effect of TC-5214 seen in this trial could represent a major breakthrough for patients with depression," said Dr. Madhukar H. Trivedi, one of the principal investigators for the trial. "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."
Targacept says it's in active discussion with a number of drugmakers about the possibility of a partnership on the drug. The company will be looking for assistance with the global development and commercialization of TC-5214. A Phase III study of the drug will begin in the second quarter of 2010 following discussion with the FDA.
- see Targacept's release
- here's TheStreet's report