Addex Therapeutics, a leading company pioneering allosteric modulation-based drug discovery and development announced that its licensing partner, Janssen Research & Development, has completed enrollment of 120 patients in a multi-centre, double-blind, phase II study of ADX71149 in adults with major depressive disorder (MDD) who are also suffering anxiety symptoms.
“The completion of enrolment in this second phase II study is an important achievement and demonstrates both the significant potential of ADX71149 and the commitment of Janssen to advance ADX71149 to this stage of development,” noted Tim Dyer, CEO at Addex. “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.”
The multi-centre, double-blind, placebo-controlled study to evaluate the efficacy and overall safety and tolerability of ADX71149 (Clinicaltrials.gov ref. NCT01582815) is being conducted as an adjunctive treatment to an antidepressant in 120 adults with major depressive disorder with anxiety symptoms and partial response to SSRI/SNRI (HDRS = 18 and Anx/Som Factor = 7). Oral ADX71149 is being administered twice-daily at doses ranging from 25mg to 150mg. Patients continue to take the same daily dose of their antidepressant. The primary endpoint of the study is the change from baseline in the 6-item subscale of 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.
ADX71149 is a novel, first-in-class potent, oral, small molecule positive allosteric modulator (PAM) of metabotropic glutamate receptor 2 (mGlu2), a Family C class of G Protein Coupled Receptor (GPCR). The development of ADX71149 is part of a worldwide research collaboration and license 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. In a phase II clinical trial of ADX71149 in schizophrenia patients, ADX71149 demonstrated positive effects in schizophrenia patients suffering from residual negative symptoms.
Addex Therapeutics is a development stage company focused on advancing innovative oral small molecules against rare diseases utilizing its pioneering allosteric modulation-based drug discovery platform.