Addex Parkinson’s Product Progressing in Early Clinical Trials
Geneva, Switzerland – Addex Pharmaceuticals (SWX:ADXN) announced that it has completed the first part of a two-part Phase I clinical trial to evaluate the newly developed modified release formulation of ADX48621. ADX48621 is scheduled to start a Phase IIa proof of concept study for the treatment of levodopa associated dyskinesia in Parkinson’s disease during the first half of 2009.
Chief Medical Officer Charlotte Keywood said: “we are pleased by the progress of ADX48621 and are preparing to start the Phase IIa proof of concept trial to study its utility in Parkinson’s disease dyskinesia next year.”
Part One was a randomized two-way crossover comparison study in 12 healthy subjects to test the pharmacokinetics, safety and tolerability of the original active pharmaceutical ingredient (API) in capsule with the modified release capsule. The modified release formulation achieved the predefined pharmacokinetic criteria required to continue into Part Two. Tolerability and safety monitoring parameters also supported continuing the trial.
Part Two is a double-blind, placebo-controlled, multiple ascending, repeat dose study in 24 healthy subjects to test the safety, tolerability and pharmacokinetics of three different doses of the modified release formulation.
Addex also has initiated a separate Phase I crossover trial to study ADX48621 interactions with gender and food in about 15 older healthy male and female subjects.
Top-line data from both trials are expected by year-end.
ADX48621 is a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM). Published studies by others using mGluR5 inhibitors have shown that this mechanism has efficacy in rodent and primate models of Parkinson’s disease – both to reduce Parkinson’s disease dyskinesia and as a levodopa sparing agent.
Dyskinesias in Parkinson’s disease patients are motor fluctuations that often result from chronic levodopa therapy. Although levodopa is widely regarded as the best available treatment for Parkinson’s disease, dyskinesias occur in more than half of patients after 5 to 10 years of levodopa therapy, with the percentage of affected patients increasing over time*. To date attempts to moderate dyskinesias via pharmaceutical treatments have been largely unsuccessful.
* Obeso JA, et al. The evolution and origin of motor complications in Parkinson’s disease. Neurology. 2000;55 (suppl 4):S13-S20.
Addex Pharmaceuticals (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), has demonstrated clinically and statistically significant efficacy in separate Phase IIa clinical trials in gastroesophageal reflux disease (GERD) patients and migraine headache patients and will start Phase IIb testing in both indications during the fourth quarter of 2008.
The Addex allosteric modulation discovery and development platform have been additionally validated through three separate product license agreements with Merck & Co., Inc. and Johnson & Johnson as well as investments by Roche Ventures and SR One, the venture investment arm of GlaxoSmithKline.
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.
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