The French biotechnology company Sensorion has announced that it has been given the go-ahead to launch a Phase I/II clinical trial of its gene therapy SENS-501 for gene-mediated hearing impairment in select European countries. .

The Phase I/II Audiogene trial is designed to evaluate the safety, tolerability, and efficacy of intra-cochlear injection of SENS-501. The trial will recruit two cohorts of paediatric patients aged six to 31 months at the time of treatment.

The gene therapy is aimed at treating patients with mutations in the gene coding for otoferlin protein, drastically increasing the likelihood of suffering severe to profound sensorineural prelingual non-syndromic hearing loss. While safety and tolerability are the primary endpoint of the trial, the auditory brainstem response will be the primary efficacy endpoint of the dose expansion cohort.

Nawal Ouzren, Sensorion’s CEO, said: “Securing approval to start the phase I/II clinical trial for SENS-501 marks a significant milestone for Sensorion and confirms our position as a leading company in the emerging field of gene therapies for hearing loss.

“Hearing loss caused by mutations of the gene encoding for otoferlin is a challenging disorder and there are no approved curative treatments for children with congenital deafness, so this is a significant unmet medical need,” they added.

According to the 19 January press release, the aim of the therapy in paediatric patients is to potentially allow young children with pre-lingual hearing loss to acquire normal speech and language faculties. Otoferlin is a protein expressed in the inner hair cells present in the cochlea and is needed for hearing by ensuring the transmission of acoustic signals to the auditory nerves.

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The news follow after the company’s reported positive safety data from the Phase IIa NOTOXIS trial (NCT05628233) of its treatment SENS-401 (arazasetron) in cisplatin-induced ototoxicity.

At the same time, German competitor Acousia Therapeutics was granted permission by the German Regulatory Authorities to launch its own Phase II trial for the treatment of patients with cisplatin-induced hearing loss.

With Sensorion acting as the trial sponsor, the Audiogene trial was developed alongside researchers at the Genetics and Physiology of Hearing Unit of the Institut Pasteur in Paris.

Christine Petit, Professor at the Institut Pasteur, added: “The SENS-501 program, which aims to correct the deficiency of a gene responsible for congenital deafness in order to restore hearing, is based on very solid pioneering research elucidating the role of otoferlin and the pathogenic processes elicited by otoferlin defect.”