Addex initiates Phase I formulation study of GERD drug

The Phase I trial (study 104) in 30 healthy volunteers has two parts: A Single-dose, three-way crossover study in 12 healthy volunteers measuring pharmacokinetics, safety and tolerability of two formulations of ADX10059 and the active pharmaceutical ingredient in capsule, which was used in Phase IIa testing, and a multiple ascending-dose pharmacokinetics, safety and tolerability study in 18 healthy volunteers.

In addition, to support the selection of the optimal dose range for the Phase IIb studies, the pharmacodynamic efficacy of three different doses will be studied using a gastroesophageal reflux disease (GERD) provocation test which involves measuring reflux episodes with pH impedance monitoring following a high fat, large volume meal.

The selection of the formulation to be used in Phase IIb testing will be made after the first part of the trial, and is expected by the end of the second quarter of 2008. Tolerability, efficacy and safety data from the study will be reported in the third quarter of 2008. The ADX10059 Phase IIb trials are scheduled to start in the fourth quarter of 2008.

Charlotte Keywood, chief medical officer of Addex, said: “This Phase I testing will enable us to identify the optimal formulation to take into Phase IIb and could provide important additional efficacy data for ADX10059 in the indication of GERD.”