Sensorion has secured approval from the French National Agency for Medicines and Health Products Safety to begin its HearConnex Phase I/II study, which will assess the company’s investigational gene therapy SENS-601 for hearing loss treatment related to GJB2 gene mutations.
The trial will take place at sites in France and will proceed in two parts, with the first part examining the safety and tolerability of unilateral intra-cochlear administration of SENS-601 across two increasing dosage groups.
The second part of the trial will evaluate the efficacy in an expansion cohort, who will receive bilateral intra-cochlear dosing at the selected dose level, and will also 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.
They are making efforts to secure approvals in other regions, including Canada, Australia, and the US, where submissions are planned for later in 2026.
Health Canada’s assessment of the clinical trial application, submitted in June 2026, is progressing, while the Hospital for Sick Children in Toronto’s Dr Sharon Cushing will act as principal investigator for the Canadian site, subject to the ongoing review completion.
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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.
Fred Chereau added that it reflects the depth of the science built over many years with their partners at the Institut Pasteur, as well as the overall quality of the dossier assembled by their multidisciplinary teams.
The company’s pipeline also includes SENS-401, a small molecule candidate in development for other hearing loss disorders, and 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.
Sensorion is expected to provide updates on the trial’s progress.
In the coming months, it will include the number of patients enrolled and any preliminary data on the safety and efficacy of SENS-601.
