AstraZeneca, Targacept Antidepressant Failed to Meet Study Goals
An experimental antidepressant from AstraZeneca Plc. and Targacept Inc. failed to meet its goal of changing a key depression rating score in the first of a series of key clinical trials, Reuters reports.
The result, announced by the companies on Tuesday, relates to the so-called Renaissance 3 Phase III study into TC-5214, a flexible dose trial conducted in Europe.
TC-5214, which is viewed by analysts as a high-risk, high-reward project, is designed to work in a new way by modulating neuronal nicotinic receptors in the brain. Over-stimulation of these receptors is thought to be associated with depression.
The drug is the product of lengthy research at Targacept, a small U.S. drugmaker that began as part of R.J. Reynolds Tobacco Co. and has for years been using its understanding of nicotine to develop experimental treatments for depression and other psychiatric disorders.
The overall Phase III trial program consists of four studies for which all results are expected by the first half of 2012. Renaissance 3 is the first of the four studies. There is also a fifth long-term safety study that will last longer.
An AstraZeneca spokeswoman said the two partners would have to look at the results from the other three shorter trials before finalizing their intentions for TC-5214.
If data from the other trials is favorable, the companies plan to file for approval of the drug in the United States in the second half of 2012, with a filing in Europe targeted for 2015.