Addex Therapeutics, a leading company pioneering allosteric modulation-based drug discovery and development, announced that its partner Janssen Pharmaceuticals, Inc., has dosed the first patient in a multi-centre, double-blind, phase II study of ADX71149 in adults with major depressive disorder who are also suffering anxiety symptoms.
ADX71149 is a positive allosteric modulator (PAM) of metabotropic glutamate receptor 2 (mGluR2), a Family C class of G protein coupled receptors (GPCR) that is being developed jointly by Addex and Janssen Pharmaceuticals, Inc. ADX71149 is also being studied in a phase II clinical trial for the treatment of positive and negative symptoms of schizophrenia, with top-line data expected in the fourth quarter of this year.
"Dosing of the first patient in this phase II study with ADX71149, in its second indication, continues our successful collaboration with, Janssen," noted Bharatt Chowrira, CEO of Addex Therapeutics. "Both partners are encouraged by the development of ADX71149 to date particularly because there is a significant medical and market opportunity for an innovative approach for treating the anxiety experienced by more than 50 per cent of patients with depression.”
The multi-centre, double-blind, placebo-controlled study to evaluate the efficacy and overall safety and tolerability of ADX71149 (Clinicaltrials.gov ref NCT01582815) will be conducted as an adjunctive treatment to an antidepressant in 94 adults with major depressive disorder with anxiety symptoms. Oral ADX71149 will be administered twice-daily at doses ranging from 25mg to 150mg. Patients will continue to take the same daily dose of their antidepressant. The primary endpoint of the study is the change from baseline in the Hamilton Anxiety Rating scale (HAM-A6) score. Secondary endpoints include change from baseline of several other clinician-administered rating scales designed to assess the severity of depression and anxiety symptoms.
The development of ADX71149 is part of a worldwide research collaboration and licence agreement between Addex and Janssen Pharmaceuticals, Inc. to discover, develop and commercialize a novel mGluR2 PAM medication for the treatment of anxiety, schizophrenia and other undisclosed indications. Under the terms of the agreement, Addex is eligible for up to a total of €112 million in milestone payments based on potential development and regulatory achievements. In addition, Addex is eligible for low double-digit royalties on sales of any mGluR2 PAM medication developed under the agreement.
Addex Therapeutics discovers and develops an emerging class of small molecule drugs, called allosteric modulators, which have the potential to be more specific and confer significant therapeutic advantages over conventional "orthosteric" small molecule or biological drugs.