Sensorion receives authorization to initiate a clinical trial in France

Sensorion announced that it has received authorization from the French National Agency for Medicines and Health Products Safety (ANSM) to launch the Phase I/II clinical trial of SENS-601, its investigational gene therapy for GJB2-related hearing loss, in France. This authorization, obtained through the Fast Track process, allows the biotechnology company to begin the HearConnex trial. Preparations for administering SENS-601 to the first patient are expected to be completed in early 2027, with data available throughout the year.

HearConnex is a two-part open-label study, first evaluating the safety and then the efficacy of treatment with SENS-601. This project represents a significant step forward for children with congenital deafness, an area where few treatments address the underlying cause.