janssenAddex Therapeutics has announced that Janssen Research & Development, on behalf of Janssen Pharmaceuticals, will commence a Phase 2 study of ADX71149 for the treatment of major depressive disorder with anxiety symptoms.

The multicentre, double-blind, placebo-controlled study is designed to evaluate the efficacy and overall safety and tolerability of ADX71149 as an adjunctive treatment to an antidepressant in 94 adults with major depressive disorder with anxiety symptoms.

Addex and Janssen Pharmaceuticals are jointly developing ADX71149, a positive allosteric modulator (PAM) of metabotropic glutamate receptor 2, a family C class of G protein-coupled receptors.

ADX71149 is also being studied in a Phase 2 trial for the treatment of positive and negative symptoms of schizophrenia.

Addex CEO Bharatt Chowrira said that the initiation of the second Phase 2 study is an indication of the potential for ADX71149 to treat more than one psychiatric disorder.

“There has been little innovation recently in the way that patients with both depression and anxiety are treated. This provides a significant medical and market opportunity for an innovative approach such as ADX71149 for treating this important psychiatric condition,” Chowrira added.

Oral ADX71149 will be administered twice-daily at doses ranging from 2mg to 150mg. Patients will continue to take the same daily dose of their antidepressant.

The change from baseline in the Hamilton Anxiety Rating scale (HAM-A6) score is the primary endpoint of the study.

The change from baseline of several other clinician-administered rating scales designed to evaluate the severity of depression and anxiety symptoms are the secondary endpoints.

Image: Xian Janssen Pharmaceutical’s facility, located in Xi’an, China. Photo courtesy of: Vberger.