June 10, 2026 —
Sensorion announced that it has selected SENS-601, also known as GJB2-GT, as its lead gene therapy program for hearing loss and has filed clinical trial applications in Canada and France. The program is designed to treat GJB2-related hearing loss, the most common cause of genetic deafness.
The company also announced that the French regulatory agency, ANSM, has granted SENS-601 a Fast Track procedure, which provides a shorter assessment timeline compared with the standard review pathway. Sensorion said it remains on track to submit an IND application in the United States and a clinical trial submission in Australia by the end of 2026.
SENS-601 is an AAV-based gene therapy developed in collaboration with Professor Christine Petit’s team at the Institut Pasteur, Institut reConnect, Institut de l’Audition, Inserm, and CNRS. The therapy is intended to treat hearing loss caused by mutations in the GJB2 gene, which plays a critical role in maintaining the ionic balance required for sound transduction in the inner ear.
GJB2 mutations are responsible for approximately 50% of autosomal recessive non-syndromic hearing loss, making the target substantially broader than many ultra-rare genetic hearing loss indications. Sensorion said SENS-601 may have potential across three patient groups: pediatric congenital deafness, progressive hearing loss in children, and early-onset severe presbycusis in adults where GJB2 mutations are implicated.
The planned Hearconnex trial will evaluate the safety, tolerability, and efficacy of intra-cochlear administration of SENS-601 in pediatric patients with GJB2 gene-mediated hearing loss. The study will also assess the clinical safety, performance, and ease of use of Sensorion’s delivery system.
As part of its strategic pipeline review, Sensorion has discontinued clinical development of SENS-501, its OTOF-related hearing loss gene therapy, and has ended recruitment in the Audiogene trial. The company cited changes in the OTOF development landscape, including the recent availability of a gene therapy demonstrating meaningful clinical efficacy in that indication. Sensorion said it will continue long-term follow-up for patients already enrolled in Audiogene.
The decision allows Sensorion to focus resources on SENS-601, where the company believes the unmet need is significantly larger and no approved gene therapy is currently available. The scientific and operational experience gained from SENS-501 and the Audiogene trial is expected to support the clinical advancement of SENS-601.
Sensorion said its cash runway has been extended through the end of 2027, supporting clinical execution and generation of first-in-human data for SENS-601. If successful, SENS-601 could become one of the leading AAV gene therapy programs entering clinical development for GJB2-related hearing loss.
