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news.Addex Pharmaceuticals, an allosteric modulation company, has reported promising Phase IIa data on ADX10059, an mGluR5 negative allosteric modulator, which shows efficacy in treating acute migraine attacks and provides evidence that inhibition of this glutamate receptor subtype could play a role in stopping migraine attacks before they start.
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In the Phase IIa trial of 129 migraine patients, significantly more patients taking ADX10059 than those taking placebo (16.7% versus 4.7%, respectively p = 0.039) were pain-free two hours after dosing.
According to Addex, ADX10059 administration yielded better pain improvement than placebo at all time points up to two hours after treatment of a migraine attack. In addition, there were trends to superiority for ADX10059 over placebo for migraine pain improvement at all time points up to two hours post-dosing.
In December 2008, Addex initiated a Phase IIb trial to study ADX10059 as a prophylactic agent in migraine. The 12-week trial will compare ADX10059 (25mg, 50mg or 100mg) versus placebo in migraine patients who suffer three or more attacks per month. Data from the migraine prevention trial are expected in the first half of 2010.
Charlotte Keywood, chief medical officer of Addex, said: “The clinical trial data for ADX10059, proved the concept that by terminating acute attacks in some patients, mGluR5 inhibition plays a role in migraine pathophysiology. Now we are looking forward to the data from our ongoing Phase IIb migraine prevention study in the first half of 2010.”