GSK/Neurocrine depression drug fails

A potential new therapy for major depression that is being developed through a partnership between GlaxoSmithKline (GSK) and Neurocrine Biosciences failed to meet its goal in a mid-stage clinical trial.

Top-line efficacy and safety results from a phase II trial of Corticotropin Releasing Factor (CRF1) receptor antagonist GSK561679 found that the drug was no more effective than placebo in patients experiencing a major depressive episode.

The study, which was conducted by GSK, enrolled 150 patients who were randomised to receive either 350mg of GSK561679 daily or placebo. The primary endpoint was change from baseline in the Bech Melancholia scale at week six. The Bech Melancholia scale is designed to measure the severity of depressive symptoms in patients with depressive illness.

Neurocrine said it will meet with GSK once the full clinical data set is complete, which is targeted for within the next few months, to decide on the next steps for the development programme. Meanwhile, clinical trials are ongoing to test the drug as a treatment for post traumatic stress disorder, anxiety and alcoholism.

Neurocrine and GSK signed a worldwide research, development and commercialisation agreement for Corticotropin Releasing Factor Receptor Antagonists for psychiatric, neurological and gastrointestinal diseases in 2001.