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Treatment for Anxious Depression Fails Mid-Stage Trial

First-in-class allosteric modulation-based drug is no better than placebo (February 7)

Disappointing results have been reported from a phase IIa clinical trial of ADX71149 in patients with anxious depression.

Based on a preliminary analysis of the study’s primary efficacy endpoint (the 6-item Hamilton Anxiety Subscale [HAM-A6]), the first-in-class allosteric modulation-based treatment did not meet the criterion for detection of an efficacy signal versus placebo.

However, despite the lack of a signal on the primary outcome measure, treatment with ADX71149 showed efficacy signals on several anxiety measures (HDRS17 anxiety somatization factor and IDS-C30 anxiety subscale) and on all depression measures (HDRS17, HAM-D6, and IDS-C30).

According to the drug’s developers (Addex Therapeutics/Janssen), the new data do not support the further development of ADX71149 for the treatment of anxious depression, but further exploration of the drug in other indications remains of potential interest.

ADX71149 is a first-in-class oral, small-molecule positive allosteric modulator (PAM) of metabotropic glutamate receptor 2 (mGlu2), a family C class of G protein-coupled receptor (GPCR).

Source: Addex Therapeutics; February 7, 2014.

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