The ARENA-2 study, licensed in the United States and Canada, is expected to include approximately 40 patients. Eight centers are already open and the results are expected early 2021. They will be followed by the filing of a registration application in the United States, with marketing in this country expected from 2021. This study was initiated following the positive results of European study ARENA-1 after 24 months of treatment.
"The recruitment of the first patient in the United States is in line with our desire to make our product internationally accessible to patients with ATRd.Because of our good results in Europe, we are confident about the outcome of this study North- American, "comments Dr. Luc-André Granier, CEO of Advicenne.
In addition, Advicenne has applied for an orphan drug designation (DMO) for ADV7103 in the United States.