On track to report top line results end of Q1 2014
Geneva, Switzerland, 29 October 2013 - Addex Therapeutics (ADXN.SW), a leading company pioneering allosteric modulation-based drug discovery and development announced today 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.
"The completion of enrolment in this second Phase 2 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 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 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.
About mGlu2 Activation and ADX71149
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 2 clinical trial of ADX71149 in schizophrenia patients, ADX71149 demonstrated positive effects in schizophrenia patients suffering from residual negative symptoms.
About Anxious Depression
Unipolar depression is the leading cause of disability worldwide (2008 WHO Global Burden of Disease Report) and anxiety symptoms are commonly reported in major depressive disorder (MDD) patients. 85% of adults with MDD exhibit significant anxiety symptoms (Gorman, 1996); and approximately 50% of outpatients with MDD have a comorbid anxiety disorder, 58% lifetime (Fava et al., 2000; Kessler et al., 1996). Comorbid anxiety results in more severe depressive symptoms, increased suicide risk, more chronic course, poorer and slower treatment response, greater functional and occupational impairment, increased societal burden/socioeconomic costs, and increased health care utilization. The first line treatments for MDD patients with comorbid anxiety are SSRIs and SNRIs, however, this subpopulation is less responsive and continues to demonstrate a great unmet need. Adjunctive treatments to SSRIs/SNRIs for anxious depression result in significant added side effect burden and are often poorly tolerated in long term treatment. The STAR*D clinical study, the largest effectiveness study evaluating next-step therapies in real-world patients with major depressive disorder, showed that patients with anxious depression were less likely to achieve remission or respond to treatment than those with non-anxious depression (Fava et al. 2008).
About Addex Therapeutics
Addex Therapeutics (www.addextherapeutics.com) is a development stage company focused on advancing innovative oral small molecules against rare diseases utilizing its pioneering allosteric modulation-based drug discovery platform. The Company`s two lead products are being investigated in Phase 2 clinical testing: dipraglurant (an mGlu5 negative allosteric modulator or NAM) is being developed by Addex to treat Parkinson`s disease levodopa-induced dyskinesia (PD-LID) and rare forms of dystonia; and ADX71149 (mGlu2 positive allosteric modulator or PAM) is being developed in collaboration with Janssen Pharmaceuticals, Inc., to treat both schizophrenia and anxiety as seen in patients suffering from major depressive disorder. Addex also has several preclinical programs including: GABAB receptor positive allosteric modulator (PAM) for Charcot-Marie-Tooth (type 1a) disease, spasticity in patients with multiple sclerosis (MS), pain, overactive bladder and other disorders; and mGlu4 PAM for MS, Parkinson`s disease, anxiety and other diseases. Allosteric modulators are an emerging class of small molecule drugs 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 target receptors and other proteins that are recognized as essential for the therapeutic modulation of important diseases with unmet medical needs.
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Disclaimer: The foregoing release may contain forward-looking statements that can be identified by terminology such as "seek", "not pursue", "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, 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 factors may in particular cause actual results with allosteric modulators of mGlu2, mGlu4, mGlu5, GABA-BR 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 Addex Therapeutics will complete the restructuring and reduction of its liabilities or any financing nor that allosteric modulators of mGlu2, mGlu4, mGlu5, GABA-BR 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 mGlu2, mGlu4, mGlu5, GABA-BR 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 mGlu2, mGlu4, mGlu5, GABA-BR 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.
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