Sensorion, Montpellier, France & Cambridge, Mass., September 3, 2026
Sensorion announced that it has received Clinical Trial Authorization (CTA) from France’s National Agency for Medicines and Health Products Safety (ANSM) to initiate HearConnex, a Phase I/II clinical trial evaluating SENS-601, the company’s investigational gene therapy for GJB2-related hearing loss. The authorization was granted on August 31, 2026, following ANSM’s Fast Track assessment process, allowing Sensorion to move forward with clinical site activities in France. The company is now preparing to activate the first French trial sites, with dosing of the first patient targeted for early 2027. Clinical data from the study are expected to be generated throughout 2027. The regulatory milestone represents an important step in bringing SENS-601 into clinical development for patients with congenital hearing loss caused by pathogenic variants in the GJB2 gene, for which there is currently no approved treatment addressing the underlying genetic cause.
HearConnex Advances SENS-601 Into Clinical Testing
The HearConnex Phase I/II trial is designed as a two-part, open-label study to evaluate the safety, tolerability and potential efficacy of SENS-601 in children with GJB2-related congenital hearing loss. In the first part of the study, participants will receive unilateral intracochlear administration of SENS-601 across two ascending-dose cohorts, allowing investigators to assess safety and tolerability at different dose levels. The second part will evaluate efficacy in an expansion cohort using bilateral intracochlear administration at the selected dose. The study will also assess the performance and usability of Sensorion’s injection system, an important component of the treatment approach. With the French CTA now approved, Sensorion has begun site start-up activities in France and is progressing toward patient enrollment. The company said the trial is intended to generate clinical information throughout 2027, providing the first opportunity to evaluate the investigational therapy in the targeted patient population.
Sensorion Expands Multi-Regional Regulatory Pathway
The French authorization is part of Sensorion’s broader plan to develop HearConnex as a multi-regional clinical trial. The company has already submitted a Clinical Trial Application to Health Canada in June 2026, with regulatory review continuing. Sensorion is also targeting a CTA submission in Australia and a U.S. Investigational New Drug (IND) application by the end of 2026. Dr. Sharon Cushing, Pediatric Otolaryngologist and Director of the Cochlear Implant Program at The Hospital for Sick Children in Toronto, serves as the Coordinating Investigator for HearConnex and is expected to lead the Canadian site subject to completion of the ongoing regulatory review. In France, Professor Natalie Loundon will serve as Principal Investigator. The multi-country development strategy is intended to support broader clinical evaluation of SENS-601 while building regulatory momentum across key markets..
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SENS-601 Program Moves Toward 2027 Clinical Milestones
Sensorion’s latest regulatory achievement follows extensive development work supporting the SENS-601 gene therapy program, including preclinical studies and manufacturing of the clinical-grade gene therapy product. The company developed SENS-601 in collaboration with researchers associated with Institut Pasteur–Institut de l’Audition/Institut reConnect, focusing on genetic hearing loss associated with GJB2 mutations. Sensorion is targeting first-patient dosing in France by early 2027, followed by clinical data generation throughout the year. The company will also host an online SENS-601 Program Day on September 22, 2026, featuring presentations on the scientific rationale, patient population and HearConnex trial design. The event will include Professor Christine Petit and Dr. Sharon Cushing alongside Sensorion’s management team. With French clinical trial authorization secured, regulatory activities continuing in Canada and additional submissions planned in Australia and the United States, Sensorion is positioning SENS-601 for a broader clinical development program focused on addressing the underlying cause of GJB2-related hearing loss.
Source: Dyne Therapeutics,press relese
