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Addex Reports Positive Results in Phase IIa Clinical Trial With,ADX10059 in Migraine

GENEVA, April 20, 2007 /PRNewswire/ -- Addex Pharmaceuticals announced today the successful completion of a Phase IIa proof of concept trial with its lead compound ADX10059 in patients with migraine. The study achieved its primary objective, the absence of pain at 2 hours after dosing, with statistical significance, and also showed trends towards improvement in pain-free status and improvement of migraine pain at other time points. ADX10059 has already recently demonstrated a potential therapeutic benefit in a Phase IIa study in gastro-esophageal reflux disease (GERD), and is currently completing a Phase IIa study in anxiety.

ADX10059 is a potent, selective, negative allosteric modulator of metabotropic glutamate receptor 5 (mGluR5 NAM). Various pre-clinical pharmacology experiments have shown that glutamate is largely responsible for signal transmission in the neural circuit involved in migraine, and mGluR5 receptors are found at strategic points along the pathway. Inhibition of mGluR5 might therefore prevent the initiation of the migraine circuit, or interrupt it once established. For this initial exploratory study on the utility of an mGluR5 NAM in the management of migraine, an acute treatment paradigm was used.

The study was conducted in 129 migraine patients at opinion leader sites in the UK and Germany, according to the gold-standard design used for acute treatment of migraine. It comprised a multi-centre, double-blind, placebo-controlled comparison of a single dose of ADX10059 with placebo, to treat a single moderate or severe (IHS Grade 2 or 3) migraine headache, in an outpatient setting. Standard efficacy outcomes were used, with the primary efficacy variable being the proportion of patients pain-free (IHS Grade 0) 2 hours after dosing.

ADX10059 met the primary endpoint, showing a statistically significant higher number of patients pain-free 2 hours after dosing compared to placeb
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