Addex Starts ADX10059 Phase I Formulation Selection Study
Geneva, Switzerland, 24 April 2008 – Addex Pharmaceuticals (SWX:ADXN) announced that it has begun Phase I testing of two formulations of ADX10059 and that it will elaborate on ADX10059 development and its pipeline during today’s R&D day.
Charlotte Keywood, chief medical officer, said: “This Phase I testing will enables us to identify the optimal formulation to take into Phase IIb and could provide important additional efficacy data for ADX10059 in the indication of GERD.”
Vincent Mutel, CEO, added: “We believe data from this program will support future Phase IIb testing of ADX10059 and significantly add to its attractiveness for our potential partners.”
The Phase I trial (study 104) in 30 healthy volunteers has two parts: 1) Single-dose, three-way crossover study in 12 healthy volunteers measuring pharmacokinetics, safety and tolerability of two formulations of ADX10059 and the active pharmaceutical ingredient (API) in capsule, which was used in Phase IIa testing; 2) a multiple ascending-dose pharmacokinetics, safety and tolerability study in 18 healthy volunteers. Also, in this part of the study to support the selection of the optimal dose range for the Phase IIb studies, the pharmacodynamic efficacy of three different doses will be studied using a GERD provocation test which involves measuring reflux episodes with pH impedance monitoring following a high fat, large volume meal. The selection of the formulation to be used in Phase IIb testing will be made after the first part of the trial, and is expected by the end of the second quarter of 2008. Tolerability, efficacy and safety data from the study will be reported in the third quarter of 2008. The ADX10059 Phase IIb trials are scheduled to start in the fourth quarter of 2008.
A second Phase I trial of ADX10059, a three-way crossover study of a single-dose of ADX10059, to study potential interactions with proton-pump inhibitors and food is planned. The primary objectives are pharmacokinetics and safety. The study in 15 healthy volunteers is slated to start at the end of the second quarter and report data in the third quarter of 2008.
Slides are available at the Addex website describing the Phase IIb trial designs for GERD and migraine.
The R&D day webcast and related slides can be viewed at www.addexpharma.com.
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.
Head of IR & Communications
+41 22 884 15 11
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.