Addex Partner to Initiate Phase 2 Clinical Trial of ADX71149 for the Treatment of Major Depressive Disorder with Anxiety Symptoms
Geneva, Switzerland, 5 June 2012 – Addex Therapeutics Ltd (SIX:ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, announced today that Janssen Research & Development, LLC, on behalf of Janssen Pharmaceuticals, Inc., 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 a positive allosteric modulator (PAM) of metabotropic glutamate receptor 2 (mGluR2), a Family C class of G Protein Coupled Receptor (GPCR) that is being jointly developed by Addex and Janssen Pharmaceuticals, Inc., formerly known as Ortho-McNeil-Janssen Pharmaceuticals, Inc. ADX71149 is also being studied in a Phase 2 clinical trial for the treatment of positive and negative symptoms of schizophrenia.
“The initiation of this second Phase 2 study is an indication of the potential for ADX71149 to treat more than one psychiatric disorder. We are delighted by our partner Janssen’s continued commitment towards advancing ADX71149 in multiple indications,” noted Bharatt Chowrira, CEO of Addex Therapeutics. “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 multicenter, 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 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.
Addex Therapeutics (www.addextherapeutics.com) 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. The Company uses its proprietary discovery platform to address receptors and other proteins that are recognized as attractive targets for modulation of important diseases with unmet medical needs. The Company’s two lead products are being investigated in Phase 2 clinical testing: dipraglurant (ADX48621, an mGluR5 negative allosteric modulator or NAM) is being developed by Addex to treat Parkinson’s disease levodopa-induced dyskinesia (PD-LID); and ADX71149 (mGluR2 positive allosteric modulator or PAM) is being developed by our partner Janssen Pharmaceuticals, Inc. to treat schizophrenia, anxiety and other undisclosed indications. Addex also is advancing several preclinical programs including: GABA-BR PAM for overactive bladder, pain and other disorders; mGluR4 PAM for Parkinson's, anxiety and other diseases; GLP1R PAM for type 2 diabetes; and mGluR2 NAM for treating Alzheimer's disease and depression. In addition, Addex has discovery programs to identify allosteric modulators of: receptor tyrosine kinase (RTK) superfamily, including TrkB PAM for treating neurodegenerative diseases (e.g. Alzheimer’s, Parkinson’s and Huntington’s diseases); and TNF receptor superfamily, including TNFR1 NAM for inflammation (e.g. rheumatoid arthritis) and other diseases.
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Disclaimer: The foregoing release may contain forward-looking statements that can be identified by terminology such as "not approvable", "continue", "believes", "believe", "will", "remained open to exploring", "would", "could", or similar expressions, or by express or implied discussions regarding Addex Therapeutics, formerly known as, Addex Pharmaceuticals, its business, the potential approval of its products by regulatory authorities, or regarding potential future revenues from such products. Such forward-looking statements reflect the current views of Addex Therapeutics regarding future events, future economic performance or prospects, and, by their very nature, involve inherent risks and uncertainties, both general and specific, whether known or unknown, and/or any other factor that may materially differ from the plans, objectives, expectations, estimates and intentions expressed or implied in such forward-looking statements. Such may in particular cause actual results with allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7, GABABR, GLP1R, TNFR1, TrkB or other therapeutic targets to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7, GABABR, GLP1R, TNFR1, TrkB or other therapeutics targets will be approved for sale in any market or by any regulatory authority. Nor can there be any guarantee that allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7, GABABR, GLP1R, TNFR1, , TrkB or other therapeutic targets will achieve any particular levels of revenue (if any) in the future. In particular, management's expectations regarding allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7, GABABR, GLP1R, TNFR1 , TrkB or other therapeutic targets could be affected by, among other things, unexpected actions by our partners, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Addex Therapeutics is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise, except as may be required by applicable laws.