France's drug regulator has cleared Sensorion to begin human testing of SENS-601, its adeno-associated virus (AAV)-based gene therapy for GJB2-related hearing loss — the most common genetic cause of congenital deafness. The French National Agency for Medicines and Health Products Safety (ANSM) granted authorization on August 31, 2026, under its Fast Track assessment procedure, allowing the Montpellier-based company to open sites and enroll patients into the HearConnex Phase I/II trial. First dosing is targeted for early 2027, with clinical data expected throughout the year.
GJB2 encodes connexin 26, a gap junction protein in cochlear supporting cells that maintains the potassium recycling required for hair cell depolarization and sound transduction. Loss-of-function mutations abolish this process, causing severe-to-profound hearing loss from birth. According to Sensorion, GJB2 mutations account for approximately 50% of autosomal recessive non-syndromic hearing loss. No approved pharmacological or gene therapy treatment targeting the underlying cause currently exists.
HearConnex is a two-part, open-label study. Part 1 will evaluate safety and tolerability of SENS-601 via unilateral intra-cochlear administration across two ascending-dose cohorts. Part 2 will assess efficacy in an expansion cohort using bilateral administration at the selected dose. The trial will also evaluate Sensorion's proprietary injection system. Dr. Sharon Cushing of The Hospital for Sick Children (SickKids) in Toronto serves as coordinating investigator, with Health Canada's review of the Canadian clinical trial application (CTA) described as on track. Sensorion is also targeting CTA submission in Australia and an investigational new drug (IND) application with the US FDA by year-end 2026.
The ANSM approval follows regulatory filings in Canada and France announced in June 2026, when Sensorion also discontinued its earlier OTOF-targeted gene therapy program, SENS-501, to concentrate resources on SENS-601. The preclinical basis for HearConnex was developed over several years in collaboration with Prof. Christine Petit's team at Institut Pasteur–Institut de l'Audition/Institut reConnect, with animal model data demonstrating hearing restoration following SENS-601 administration, according to the company.