Sensorion has received authorisation from the French National Agency for Medicines and Health Products Safety (ANSM) for its clinical trial application to begin HearConnex, a Phase I/II study assessing its investigational gene therapy SENS-601 for hearing loss treatment related to gap junction beta-2 (GJB2) gene mutations.
The multi-regional trial will take place at sites in France.
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Its approval followed the conclusion of ANSM’s fast track assessment, which significantly shortens the typical review period.
The HearConnex trial will proceed in two parts. The first part will examine the safety and tolerability of unilateral intra-cochlear administration of SENS-601 across two increasing dosage groups.
HearConnex’s second part will evaluate the efficacy in an expansion cohort, who will receive bilateral intra-cochlear dosing at the selected dose level. The trial is also set to test the company’s injection system for safety, performance, and usability.
Sensorion plans to begin activities at French sites aiming to treat the first patient by early 2027, with clinical data expected throughout that year. Efforts to secure approvals are ongoing in other regions.
The Hospital for Sick Children in Toronto paediatric otolaryngologist and HearConnex Coordinating Investigator Dr Sharon Cushing will act as principal investigator for the Canadian site, subject to the ongoing review completion.
Health Canada’s assessment of the clinical trial application, submitted in June 2026, is progressing, while submissions for Australia and the US are planned for later in 2026.
Sensorion CEO Fred Chereau said: “Securing approval to initiate HearConnex marks a significant milestone for Sensorion and, above all, for the children and families affected by congenital DFNB1A hearing loss, for whom no treatment addressing the underlying biological cause of the disease exists today.
“It reflects the depth of the science built over many years with our partners at the Institut Pasteur-Institut de l’Audition/Institut reConnect, as well as the overall quality of the dossier assembled by our multidisciplinary teams.”
The company’s pipeline also includes SENS-401, a small molecule candidate in development for other hearing loss disorders.
In March 2026, Sensorion reported a six-month update from the Audiogene Phase I/II clinical trial’s cohort 2 assessing SENS-501, its gene therapy candidate for otoferlin-mediated congenital deafness.
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