Sensorion Announces Preliminary Positive Data from the First Cohort of the Audiogene Phase 1/2 Gene Therapy Clinical Trial

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[{"type":"list","items":[{"val":[{"type":"text","content":"SENS-501, including the surgical delivery of the gene therapy, shows a good safety profile in all patients treated so far","length":121,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Three-month results from a SENS-501 treated toddler in the first cohort demonstrate early promising hearing improvement ","length":119,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"The second cohort assessing a higher dose of SENS-501 is ongoing and recruitment is close to being completed","length":108,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":348,"olType":false},{"type":"text","content":"MONTPELLIER, France, July 01, 2025--(BUSINESS WIRE)--Regulatory News:","length":69,"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 preliminary positive data from the first cohort of the Phase 1/2 Audiogene clinical trial evaluating the low dose of SENS-501, the Company’s gene therapy candidate being developed to treat a specific form of congenital deafness linked to mutations in the OTOF (otoferlin) gene. The second cohort at a higher dose is ongoing and recruitment is close to being completed.","length":572,"tagName":"p"},{"type":"text","content":"The results from all patients dosed to date (5) confirm that SENS-501 and the corresponding surgical procedure are well tolerated by all participating infants and toddlers (aged 6 to 31 months and naive of cochlear implants at the time of the injection, as per study protocol) having received a gene therapy injection. Intracochlear administration of SENS-501 was uneventful, and no serious adverse events or serious side effects were reported.","length":444,"tagName":"p"},{"type":"text","content":"Three patients were enrolled into Cohort 1 and received a low dose of SENS-501 of 1.5E11 vg/vector/ear, corresponding to the minimally effective dose in preclinical studies. The primary objective is to assess the safety and feasibility of the intra-cochlear administration of SENS-501. In Cohort 1, early signs of hearing improvement were observed in Patient 3, aged 11 months at the time of injection. The clinical response observed in Patien...

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