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

o. At 2 hours post-dose, 16.1% of patients taking ADX10059 were pain-free compared to 4.5% taking placebo (p = 0.039). A benefit of ADX10059 on migraine pain could be seen from 1 hour after dosing, with the compound being numerically superior to placebo at 1.0 and 1.5 hours post-dose. The magnitude of active versus placebo response at 2 hours (3.6 fold for pain-free and 1.6-fold for mild/no pain) was similar to that seen in the acute treatment migraine trials for the triptans (see ref. 1 below). In addition, there were trends to superiority for ADX10059 over placebo for migraine pain improvement (mild or no pain) at all time points up to two hours post-dosing. For other secondary efficacy endpoints there were no statistically significant differences between the two dose groups.

"The study results show an important and novel principle in the treatment of migraine with the positive outcome using an mGluR5 receptor modulator. The data offer the real prospect of development of a completely new class of medicines that modulate the effects of glutamate and thus offer a neural - nerve-based - therapy for migraine sufferers," commented Professor Peter Goadsby, Institute of Neurology, Queen Square London, and Department of Neurology, University of San Francisco, California.

"These results are the first demonstration of the involvement of mGluR5 in the migraine process," said Dr Vincent Mutel, CEO of Addex. "We believe that ADX10059 could play a significant role in the long term management of this disease, and have given the green light to initiate a Phase IIb trial."

About Migraine

Migraine is a condition characterized by recurrent episodes of headache accompanied by a variety of other symptoms such as nausea, light and sound sensitivity, and fatigue. Attacks may be preceded by aura (usually visual phenomena such as flashing lights, zigzag lines and loss of visual fields) in about 40% of patients. An average migraine patient suffers 12 attacks a y
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