Sensorion: ANSM Authorizes HearConnex Clinical Trial for Its Gene Therapy
The Montpellier biotech company is advancing to the clinical phase with its lead candidate, a gene therapy targeting a form of genetic deafness for which no treatment addressing the underlying cause currently exists. The authorization paves the way for the launch of the HearConnex trial in France.
Phase I/II Trial Authorized Through Accelerated Procedure
Sensorion announced on September 3, 2026, that it received authorization from the National Agency for the Safety of Medicines and Health Products (ANSM) on August 31, 2026, to initiate HearConnex, the Phase I/II clinical trial of SENS-601 in France. This candidate is presented as the company's lead gene therapy program, intended to treat hearing loss linked to the GJB2 gene.
The authorization was obtained through the ANSM's accelerated evaluation procedure (Fast Track), which provides a reduced examination timeframe compared to the standard pathway. Pathogenic variants of the GJB2 gene are among the most frequent causes of genetic deafness.
First Patient Targeted for Early 2027 and International Submissions
HearConnex is designed as an open-label study in two parts. The first will evaluate the safety and tolerability of SENS-601 following unilateral intra-cochlear administration across two cohorts at escalating doses, and the second will evaluate efficacy following bilateral administration at the selected dose.
Site activation activities in France are underway, with the first patient treatment targeted for early 2027 and clinical data expected throughout 2027. The trial is multi-regional: Health Canada's review of the application submitted in June 2026 is ongoing, and the company aims to submit an application in Australia and an IND application in the United States by the end of 2026.
Sensorion will also hold an online event, the SENS-601 Program Day, on September 22, 2026, with the participation of Professor Christine Petit and Dr. Sharon Cushing.
