Date: 2013-10-29
Type of information:
phase: 2
Announcement: completion of patient enrolment
Company: Janssen Research & Development (J&J - USA) Addex Therapeutics (Switzerland)
Product: ADX71149 (JNJ-40411813)
Action
mechanism: ADX71149 is a positive allosteric modulator (PAM) of metabotropic glutamate receptor 2 (mGluR2), a Family C class of G Protein Coupled Receptor (GPCR).
Disease: adults with major depressive disorder who are also suffering anxiety symptoms
Therapeutic area: Mental diseases - CNS diseases
Country:
Trial
details: The multicenter, 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 ³ 18 and Anx/Som Factor ³ 7). 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.
Latest
news: * On October 29, 2013, Addex Therapeutics, a Swiss company pioneering allosteric modulation-based drug discovery and development, has announced that Janssen Research & Development, LLC, on behalf of Janssen Pharmaceuticals, Inc., has completed enrollment of 120 patients in a multicenter, double-blind, Phase 2 study of ADX71149 in adults with major depressive disorder who are also suffering anxiety symptoms.* On September 17, 2012, Addex Therapeutics has announced that Janssen Research & Development has dosed the first patient in a multicenter, double-blind, Phase 2 study of ADX71149 in adults with major depressive disorder who are also suffering anxiety symptoms. 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.
* On June 5, 2012, Addex Therapeutics has announced that Janssen Research & Development (previously Ortho-McNeil-Janssen Pharmaceuticals) is initiating a multicenter, double-blind, Phase 2 study of ADX71149 in adults with major depressive disorder who are also suffering anxiety symptoms.
ADX71149 is also being studied in a Phase 2 clinical trial for the treatment of positive and negative symptoms of schizophrenia.
The development of ADX71149 is part of a worldwide research collaboration and license agreement between Addex and Janssen Pharmaceuticals 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.
