Addex initiates Ph IIa ADX10059 trial

Geneva, Switzerland-based Addex Pharmaceuticals has initiated a Phase IIa proof-of-concept study on its lead compound ADX10059 in patients with moderately severe dental anxiety. This is the third indication in a Phase IIa development program in which ADX10059 is also being evaluated for acute treatment of migraine and for prevention of acid reflux in patients with gastro-oesophageal reflux disease. The latter two studies are being conducted in the UK, France and Germany, with results expected in the first quarter of 2007.

Addex noted that the agent successfully completed three Phase I trials in over 100 healthy subjects during the first half of 2006. The latest multicenter study, being carried out at specialist dental research centers in the UK, is a double-blind, placebo-controlled comparison of a single dose of ADX10059, to treat patients with moderately severe dental anxiety who are undergoing standard dental treatment. Efficacy variables include patient rating of anxiety during the procedure, using visual analog scales and physiological measurements of stress. Effects on sedation will also be measured.

ADX10059 is intended as a non-sedating alternative to benzodiazepines for the short-term treatment of acute anxiety states, examples of which include acute stress disorder, fear of flying, acute social anxiety and fear of medical and dental procedures. Dental anxiety is an example of the latter condition and is a common disorder, affecting 7% to 10% of adult populations, Addex noted.