AZ-Targacept depression candidate moves into phase IIb
pharmafile | February 9, 2011 | News story | Research and Development | AZ, AstraZeneca, TC-5214, Targacept, depression, major depressive disorder
AstraZeneca and Targacept have begun a phase IIb trial of TC-5214 as a ‘switch’ monotherapy for patients with depression.
The nicotinic channel blocker will be given to sufferers of major depressive disorder (MDD) for whom initial antidepressant therapy has not worked.
The companies are also carrying out a phase III study, called RENAISSANCE, for TC-5214 as an adjunctive treatment for MDD.
AstraZeneca and Targacept hope this will support marketing authorisations for the drug in the US next year and Europe in 2015, allowing it to tap into a global antidepressant market estimated to be worth $20 billion.
Enrolment has started for the new phase IIb study, which will look at MDD patients who have not responded adequately to open label treatment with one of six commonly-prescribed SSRI or SNRI antidepressants.
They will be switched to either one of two fixed doses of TC-5214, or the active control duloxetine or placebo, twice daily for eight weeks.
Patients will be measured on their change from double-blind baseline at the end of the dosing period on the Montgomery-Asberg Depression Rating Scale as compared to placebo.
The study will enrol around 350 patients into this double blind phase from 75 centres worldwide.
Depression is associated with increased cholinergic tone – that is, overstimulation of neuronal nicotinic receptors (NNRs) and other brain receptors activated by the neurotransmitter acetylcholine.
TC-5214 modulates the activity of some NNRs, which is in turn believed to help normalise cholinergic tone, thus having an antidepressant effect.
MDD affects approximately 42 million people worldwide, and AstraZeneca bought the rights to the investigative compound from Targacept in December 2009 for $200 million.
Under the terms of the deal, initial global development costs are split 80-20 between AstraZeneca and Targacept.
The companies already have other drugs in clinical development for cognitive disorders following an earlier deal.
These are: AZD3480 for attention deficit/hyperactivity disorder, AZD1446 for Alzheimer’s disease and TC-5619 for cognitive dysfunction in schizophrenia.
Adam Hill
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