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Addex Pharmaceuticals New formulation of ADX10059 selected
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Geneva, Switzerland, 4 June 2008 - Addex Pharmaceuticals (SWX:ADXN) announced that it has started Study 105, a Phase I clinical trial evaluating the interaction of a new formulation of ADX10059 with proton pump inhibitors and food. A formulation of ADX10059 was selected at the end of May, upon completion of part one of Study 104, a separate ongoing Phase I trial.
In 2007 ADX10059, a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM), achieved clinical proof of concept demonstrating clinically and statistically significant effects in separate Phase IIa trials for gastroesophageal reflux disease (GERD) and migraine. In preparation for Phase IIb testing, starting later this year, Addex developed a more commercial formulation of ADX10059.
The objective for the new formulations is to reduce the rapid absorption and onset of action of ADX10059 while optimizing the exposure profile compared to the original form, the active pharmaceutical ingredient (API) in capsules, which was used in Phase IIa testing. In preclinical studies new formulations of ADX10059 reduced the rapid absorption and improved the exposure profile compared to API filled capsules.
Charlotte Keywood, chief medical officer, said: "In part one of Study 104 both of the new formulations of ADX10059 were well differentiated from the original API filled capsules. We have selected the best new formulation for further study. In addition to studying the interactions of ADX10059 with proton pump inhibitors and food in Study 105, our goal in part two of Study 104 is to show that we are able to achieve the optimized exposure profile in humans."
Study 105 is a Phase I three-way crossover study of a single-dose of ADX10059, to study potential interactions with proton-pump inhibitors and food. The primary objectives are pharmacokinetics, tolerability and safety. The study in 15 healthy volunteers is scheduled to report data in September 2008.
Study 104 is a two part trial in 36 healthy subjects, the first of which has been completed. Part one was a single-dose, three-way crossover trial in 12 subjects where the pharmacokinetics, safety and tolerability of two new formulations of ADX10059 were compared to the API filled capsule.
Part two of Study 104 is a multiple ascending-dose study of the pharmacokinetics, safety and tolerability of three different doses of the new formulation in 24 additional healthy subjects. Also, to support the selection of the optimal dose range for the Phase IIb studies, the pharmacodynamic efficacy of each dose will be assessed using a human model of GERD, which involves measuring reflux episodes with pH impedance monitoring following a high fat, large volume meal. Data from Study 104 are also scheduled to be reported in September 2008.
Phase IIb trials of ADX10059 are scheduled to start in the fourth quarter of 2008 in GERD and migraine prevention, two blockbuster indications.
About Addex
Addex Pharmaceuticals Ltd (www.addexpharma.com) discovers and develops allosteric modulators, an emerging class of small molecule therapeutic agents. Allosteric modulation may offer more sophisticated ways to normalize biological signaling compared to classical orthosteric agonist or antagonist drugs. Allosteric, literally translated from its Greek roots, means "other site". Thus, allosteric modulators bind receptors at sites that are distinct from the binding sites of classical small molecule orthosteric agonist and antagonist drugs.
The most advanced drug candidate, ADX10059, a negative allosteric modulator (NAM) of metabotropic glutamate receptor 5 (mGluR5), recently demonstrated clinically and statistically significant efficacy in separate Phase IIa clinical trials in gastroesophageal reflux disease (GERD) patients and migraine headache patients.
The Addex allosteric modulation discovery and development platform has been additionally validated through collaborations with Merck & Co., Inc. and Johnson & Johnson. Contacts
Chris Maggos Head of IR & Communications Addex Pharmaceuticals +41 22 884 15 11 chris.maggos@addexpharma.com
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 Pharmaceuticals Ltd, 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 Pharmaceuticals Ltd 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 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 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 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 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 Pharmaceuticals Ltd 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.
