Sensorion has secured authorization from French regulators to initiate a clinical trial of its experimental gene therapy for a rare form of inherited hearing loss. The company announced that the French National Agency for Medicines and Health Products Safety has approved the HearConnex study, a Phase I/II trial testing SENS-601 in patients with hearing loss linked to GJB2 gene mutations.
The HearConnex trial will evaluate SENS-601 in two sequential parts. The first phase aims to assess safety and tolerability by administering the therapy to one ear across two groups receiving different doses. If this stage proves successful, a second portion will test the treatment in both ears at a selected dose level. During the study, Sensorion also plans to evaluate its custom injection system.
The company aims to enroll patients at French clinical sites, with the goal of treating the first participant by early 2027. Full trial results are expected to emerge throughout that year.
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France is just one part of Sensorion’s international expansion plans. The company submitted its clinical trial application to Health Canada in June 2026, and that review is currently ongoing. Sensorion has also indicated plans to file regulatory submissions in Australia and the United States later in the year.
Dr Sharon Cushing, a pediatric otolaryngologist at the Hospital for Sick Children in Toronto, will serve as coordinating investigator for the Canadian portion of the trial, contingent on Health Canada completing its review. This multi-regional structure reflects Sensorion’s strategy of running parallel approval processes across different jurisdictions.
The French approval came through ANSM’s fast-track assessment pathway, which shortens the typical review timeline. Sensorion did not disclose specifics about the fast-track process or how long the standard review would have taken.
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SENS-601 is Sensorion’s lead gene therapy candidate for hearing loss. Credit: R Photography Background / Shutterstock.com. 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.
CEO Fred Chereau stated that the authorization marks a significant milestone for the company 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.
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.
