Sensorion Receives Approval for SENS-601 Trial in France

Sensorion has obtained clinical trial authorization from the French ANSM for its gene therapy, SENS-601, targeting GJB2-related hearing loss. This approval, dated August 31, 2026, allows the initiation of the HearConnex Phase I/II trial in France. SENS-601 is designed to address genetic deafness caused by GJB2 gene variants. Currently, no approved therapies target this underlying cause.

The HearConnex trial will first assess safety and tolerability, followed by efficacy. The first patient dosage is planned for early 2027, with results expected throughout the year. The trial connects Sensorion's years of research in collaboration with Prof. Christine Petit's team and successful preclinical findings.

HearConnex is multi-regional, involving a Canadian site pending Health Canada's review, with further submissions planned for Australia and the U.S. Sensorion plans to host an online event on September 22, 2026, to discuss the SENS-601 program.