AZ and Targacept’s novel depression drug misses target
pharmafile | November 8, 2011 | News story | Research and Development, Sales and Marketing | AstraZeneca
AstraZeneca and Targacept’s next generation depression drug has failed to meet its primary endpoint in a late-stage trial.
The first of four Phase III studies comparing TC-5214 as an add-on therapy to an antidepressant in patients with major depressive disorder (MDD), who not respond to initial therapy, did not meet its primary endpoint of changing a key depression rating score.
The failure of the RENAISSANCE 3 study will be a blow for AstraZeneca that is relying on the drug to help bolster its relatively weak pipeline.
As with many smaller firms the success of TC-5214 is closely aligned to the fate of US-based firm Targacept, whose share price performance will depend on the drug’s success.
AstraZeneca agreed in 2009 to pay as much as $1.24 billion for certain rights to the drug, including an upfront payment of $200 million.
The drug works differently to established antidepressants by modulating neuronal nicotinic receptors in the brain, which are thought to be associated with depression.
The established mechanism of action for antidepressants is to increase the uptake of serotonin and norepinephrine in the brain, such as with Lilly’s big selling Cymbalta (duloxetine), which made $1.1 billion in the third quarter.
The RENAISSANCE clinical trial programme consists of four randomised, double blind, placebo controlled Phase III efficacy and tolerability studies.
Top-line results from all four studies are expected by the first half of 2012.
Both firms said despite today’s setback they would still seek approval for the drug in the US in the second half of 2012, with a filing in Europe targeted for 2015.
Ben Adams
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