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Sensorion Completes Patient Enrollment of the Second Cohort in Audiogene Phase 1/2 Gene Therapy Clinical Trial
MONTPELLIER, France, July 29, 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 the completion of patient enrollment in the second cohort of its Phase 1/2 Audiogene clinical trial evaluating SENS-501, the Company’s gene therapy candidate being developed to treat a specific form of congenital deafness linked to mutations
About this update from Sensorion Sas
[{"type":"text","content":"MONTPELLIER, France, July 29, 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 the completion of patient enrollment in the second cohort of its Phase 1/2 Audiogene clinical trial evaluating 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.","length":476,"tagName":"p"},{"type":"text","content":"Recruitment of the second cohort, composed of three patients aged between 6 and 31 months, was recently completed with the injection of the third patient. Patients in this second cohort were administered, unilaterally, a dose of d4.5E11 vg/vector/ear of SENS-501 which was higher than the dose in the 1st cohort (1.5E11 vg/vector/ear). For all patients treated in the first and second cohorts, the surgical procedure was well tolerated: the intra-cochlear administration of the gene therapy product was uneventful. No serious adverse events and no serious side effects were reported. Early signs of hearing improvement have been observed in Patient 3, aged 11 months at the time of injection, three months after receiving the low dose.","length":735,"tagName":"p"},{"type":"text","content":"Nawal Ouzren, Chief Executive Officer of Sensorion, commented: "The completion of patient enrollment in the second cohort in Audiogene is an important milestone as it enables us to attest to the safety of the surgical approach, as no serious adverse events have been observed in all six patients injected, and of the good tolerability of SENS-501 to date. I look forward to advancing this innovative and unique program to its next steps, notably with the planned Data Monitoring Committee meeting, and to providing an update as soon as the data have sufficiently matured. On behalf of my colleagues, I would like to extend gratitude to the patients' families for their trust, as well as all the healthcare professionals involved in this clinical trial."","length":767,"tagName":"p"},{"type":"text","content":"Professor Natalie Loundon, M.D., Director of the Center for Research in Pediatric Audiology, Pediatr...