Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders announces the completion of enrollment of patients in the first cohort of the Audiogene Phase 1/2 gene therapy clinical trial.

Recruitment of the first cohort (three patients) was completed as planned, with the third patient receiving an injection of SENS-501 gene therapy product in December 2024. For all patients treated in the first cohort, the surgical procedure was well tolerated: the intra-cochlear administration of the gene therapy product was uneventful, and no serious adverse events were reported. Audiogene is the first gene therapy clinical trial addressing a unique homogeneous population of infants and toddlers (aged 6 to 31 months at the time of the injection) naïve of cochlear implants. Audiogene’s clinical trial design has been intended to assess SENS-501 gene therapy product capacity not only to restore hearing but also to allow the infants and toddlers to acquire and develop normal speech.

Nawal Ouzren, Chief Executive Officer of Sensorion, declared: “I am very pleased with the progress Sensorion has realised in its Phase 1/2 gene therapy clinical trial. The injection of the third and last patient of the first cohort, less than a year after the clinical trial application authorization, is a major accomplishment for Sensorion. The surgery of the infant was uneventful, and no serious adverse events were reported. I am very excited about the KOL event we plan in early 2025, with leading field experts, to present and comment on a fuller set of data measurements. I am looking forward to advancing SENS-501 and assessing its ability to restore hearing and enable normal speech acquisition and development in the treated toddlers and infants.”