French biotech firm Sensorion says an independent review has found no safety concerns so far in a study testing a new treatment for babies and toddlers born deaf
Sensorion, a French biotechnology company that develops treatments for inner-ear disorders, has reported encouraging early news from a clinical trial of a gene therapy designed to treat a rare form of inherited deafness.
An independent safety committee has reviewed the first stages of the Audiogene Phase 1/2 trial and found no safety concerns, allowing the study to continue.
Sensorion is a clinical-stage biotech company based in France that focuses on treatments for hearing loss and balance disorders. Its work includes medicines and gene therapies aimed at conditions for which there are currently few or no effective treatments.
What the trial is testing
The Audiogene trial is testing SENS-501, an experimental gene therapy for children born with deafness caused by a faulty OTOF gene. This gene is essential for passing sound signals from the inner ear hair cells to the auditory nerve.
The study is enrolling infants and toddlers aged six months to just over two years. The treatment is delivered to only one ear, allowing doctors to compare treated and untreated ears while the brain is still highly adaptable.
Safety review passed
An independent data monitoring committee examined early data from the first two small groups of children in the study. Sensorion said the committee found that the procedure was well tolerated and that no serious side effects were reported. Based on that review, the committee supported continuing the trial as planned.
Early signs of hearing response
Sensorion has also shared early indications that the gene therapy may be having an effect. In the second group of children, two out of three showed improved responses to sound tests three months after the gene therapy was implemented.
The company stressed that these are early signals only. More time and data are needed to understand whether the changes are lasting and meaningful in everyday listening.
Why this matters
For families affected by congenital deafness linked to the OTOF gene, current options are limited. Management options such as hearing aids or cochlear implants help many children, but they do not address the underlying cause.
SENS-501 aims to treat hearing loss at its source by providing the inner ear with a working copy of the gene, thereby enabling more natural hearing.
Caution remains essential
“Any research involving very young children quite rightly moves slowly,” said Abigail Pillay, a Clinical Audiologist at Hearology®. “Seeing reassuring safety data is an important first step, but it will take time to know whether this kind of treatment can make a real difference for families.”
References
- Sensorion Reports Independent Data Monitoring Committee - Report on the monitoring committee’s verdict
- Sensorion Completes Patient Enrollment of the Second Cohort in Audiogene Phase 1/2 Gene Therapy Clinical Trial - Sensorion, a clinical-stage biotechnology company, announced the completion of patient enrollment for the second cohort in its Audiogene Phase 1/2 gene therapy clinical trial
- Sensorion Reports 2025 Half-Year Results - Sensorion reported its 2025 half-year results and provided a corporate update
