Sensorion announced today that it has received approval for its Phase 1/2 clinical trial for SENS-501 (OTOF-GT), its most advanced gene therapy candidate for hearing disorders.

The SENS-501 gene therapy program aims to restore hearing in patients with mutations in the gene coding for otoferlin and suffering from severe hearing loss. This program is being developed in partnership with the Institut Pasteur.

This clinical trial, called Audiogène, aims to assess the safety, tolerability and efficacy of SENS-501 in young children.

Nawal Ouzren, Chief Executive Officer of Sensorion, commented: "Obtaining authorization to start the Phase 1/2 clinical trial for SENS-501 marks an important milestone for Sensorion and confirms our position as one of the leading companies in the emerging field of gene therapies for hearing loss. Hearing loss caused by mutations in the gene coding for otoferlin is a complex disorder and represents a significant unmet medical need, as there is no approved cure for children with this congenital deafness'.

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