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Sensorion Reports Independent Data Monitoring Committee Raises No Safety Concerns and Agrees to Continue SENS-501’s Audiogene Phase 1/2 Trial
MONTPELLIER, France, December 08, 2025--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced that the Data Monitoring Committee (DMC) supports the continuation of the Audiogene Phase 1/2 clinical trial of SENS-501, the Company’s gene therapy program being developed to treat a specific form of congenital deafness linked to mutation
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[{"type":"text","content":"MONTPELLIER, France, December 08, 2025--(BUSINESS WIRE)--Regulatory News:","length":73,"tagName":"p"},{"type":"text","content":"Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced that the Data Monitoring Committee (DMC) supports the continuation of the Audiogene Phase 1/2 clinical trial of SENS-501, the Company’s gene therapy program being developed to treat a specific form of congenital deafness linked to mutations in the OTOF (otoferlin) gene. Based on the DMC’s safety observations to date which include good procedural tolerance, the Committee has raised no safety concerns.","length":607,"tagName":"p"},{"type":"text","content":"The Audiogene trial is designed to evaluate the safety, tolerability and efficacy of intra-cochlear administration of SENS-501 for the treatment of OTOF gene-mediated hearing loss in paediatric patients aged 6 to 31 months at the time of treatment. By intervening during the critical early window of brain plasticity and enrolling infants who have not yet received a cochlear implant, the study aims to isolate the therapeutic effect of SENS-501 as monotherapy. The trial consists of two sequential dose-escalation cohorts, each involving unilateral injection to allow a clear assessment of the kinetics of hearing restoration. Moreover, Audiogene aims to evaluate the usability, the clinical and the technical performances of the injection system in development.","length":763,"tagName":"p"},{"type":"text","content":"On December 4th, the DMC reviewed the first part of the SENS-501 Audiogene Phase 1/2 clinical trial including cohort 2 which completed enrolment in July 2025. This cohort includes three patients aged between 6 and 31 months who received the dose 2 of SENS-501 (4.5E11 vg/vector/ear). Across both the first and second cohorts, the surgical procedure was well tolerated, and intra-cochlear administration of SENS-501 was uneventful, and no serious adverse events or serious side effects have been reported.","length":504,"tagName":"p"},{"type":"text","content":""The safety findings combined with the early efficacy signals observed so far in infants and toddlers support further clinical investigation of SENS-501," said Nawal Ouzren, Chief Executive ...