CAMBRIDGE, Mass. — Sensorion has received authorization from French regulators to begin a Phase I/II clinical trial of SENS-601, its investigational gene therapy for GJB2-related hearing loss.
The French National Agency for Medicines and Health Products Safety approved the HearConnex trial on Aug. 31 through its Fast Track assessment process.
Sensorion said site activation activities are underway in France, with dosing of the first patient targeted for early 2027. Clinical data are expected to be generated throughout 2027.
SENS-601 is Sensorion’s lead gene therapy candidate for hearing loss caused by pathogenic variants in the GJB2 gene, one of the most common causes of genetic deafness. There is currently no approved treatment that addresses the underlying genetic cause of the condition.
HearConnex will be conducted as a two-part, open-label study. The first portion will evaluate the safety and tolerability of SENS-601 following administration into one cochlea across two ascending-dose groups.
The second portion will assess efficacy in an expansion cohort using bilateral intra-cochlear administration at the selected dose. The study will also evaluate the safety, performance and usability of Sensorion’s injection system.
Sensorion said the clinical program follows years of research conducted with Christine Petit’s team at Institut Pasteur–Institut de l’Audition/Institut reConnect. Preclinical studies showed significant hearing restoration in animal models, according to the company.
“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,” said Fred Chereau, Chief Executive Officer of Sensorion.
The company is designing HearConnex as a multi-regional trial. Sharon Cushing, M.D., Pediatric Otolaryngologist and Director of the Cochlear Implant Program at The Hospital for Sick Children in Toronto, will serve as Coordinating Investigator and is expected to serve as Principal Investigator for the Canadian site, subject to regulatory approval.
Health Canada is reviewing a clinical trial application submitted in June. Sensorion also plans to submit a clinical trial application in Australia and an Investigational New Drug application in the United States by the end of 2026.
“Children born with GJB2-related hearing loss, and their families, hope for additional therapeutic options that address the underlying cause of the condition,” said Natalie Loundon, M.D., Director of the Center for Research in Pediatric Audiology at Necker Enfants Malades in Paris and Principal Investigator for the French study.
Sensorion will also hold an online SENS-601 Program Day on Sept. 22 to discuss the science behind the therapy, the target patient population and the design and endpoints of the HearConnex trial.
