Sensorion (Euronext Growth Paris:ALSEN), a clinical-stage biotechnology company that specialises in hearing loss therapies, said on Thursday that it has received authorisation from France's National Agency for Medicines and Health Products Safety (ANSM) to initiate HearConnex, a Phase I/II clinical trial of its investigational gene therapy SENS-601 for GJB2-related hearing loss.

This authorisation was granted under ANSM's Fast Track assessment process, which provides a shorter review period than the standard pathway.

HearConnex will evaluate SENS-601's safety and tolerability in two ascending-dose cohorts before assessing efficacy in an expansion cohort at the selected dose, while also evaluating Sensorion's injection system. Sensorion is beginning site start-up activities in France and targets dosing the first patient by early 2027, with clinical data expected throughout 2027.

The company said the authorisation follows extensive preclinical work demonstrating hearing restoration in relevant animal models, along with toxicology studies and successful GMP manufacturing of the clinical-trial drug product.

HearConnex is planned as a multi-regional study, with Dr. Sharon Cushing serving as coordinating investigator and principal investigator for the Canadian site, subject to ongoing Health Canada review.

Sensorion said the Canadian regulatory review remains on track and it plans to submit clinical trial applications in Australia and an Investigational New Drug application in the United States by the end of 2026.