Addex begins Ph II ADX10059 migraine study

Switzerland's Addex Pharmaceuticals, a specialist in the discovery of therapeutics for central nervous system disorders, says it has begun a Phase II trial program of its lead developmental drug, ADX10059. The firm added that the product, a selective allosteric modulator of the metabotropic glutamate receptor 5 (mGluR5), has already demonstrated its safety and tolerability across a broad range of doses in three Phase I assessments in healthy volunteers.

The first Phase IIa trial, which is being carried out in Germany, is designed to evaluate the agent's use in the treatment of migraine, in comparison with placebo. Efficacy will be assessed in terms of the proportion of patients who are pain-free two hours after dosing.

Addex said that it plans to initiate two additional Phase II assessments of the drug in acute anticipatory anxiety, its main target indication, as well as in the treatment of acid reflux in patients with gastro-oesphageal reflux disease (GERD), in which mGluR5 is also thought to play a role.