Addex To Terminate Migraine Prevention Study Prematurely

Addex Pharmaceuticals has decided to end prematurely the migraine prevention study 206.

Reportedly, the routine safety monitoring of blinded data in study 206, has revealed an incidence of abnormalities of liver function tests that is higher than expected in the population. The abnormalities were apparent from day 28 of dosing but the incidence and severity appear to increase progressively with increasing duration of participation in the study.

Despite the fact that the treatment allocation remains blinded, Addex is of the opinion that the risk to benefit profile of the drug observed in the study is not sufficiently favorable to justify continuation of the trial, and is terminating the study in the best interests of patient safety. The full benefit risk profile of ADX10059 in this indication will be evaluated once the study has been unblinded and all efficacy and safety data have been analysed, said the company.

Charlotte Keywood, chief medical officer of Addex, said: “No liver function abnormalities have been seen in any of the previously reported clinical trials, several of which explored higher doses, including the recently reported study ADX10059-204, a 2-week study of monotherapy in 103 Gerd patients. Study 205 a 4-week study of ADX10059 as an add-on therapy to PPIs in Gerd patients, is due to un-blind around the end of the year. The data from that study will also help in the determination of the overall safety profile of the drug.”

Vincent Mutel, chief executive officer of Addex, said: “This is an unfortunate and unexpected development. We are working to rapidly understand the relationship of the liver function abnormalities to the treatment and the implications for development of ADX10059 in migraine prevention and other indications.”