Sensorion has announced that the Data Monitoring Committee (DMC) recommended 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.
PeopleImages.com - Yuri A Shutterstock
clinical trial concept.
Nawal Ouzren, chief executive officer of Sensorion, said: “On behalf of the Sensorion team, I wish to thank the DMC members for their review of Audiogene’s safety data generated to date and I am pleased with the Committee’s recommendation to proceed with the trial without modifications.”
The recommendation made by the DMC confirms the favourable safety profile of SENS-501 at the first dose level in children aged 6 to 31 months at the time of administration while the intra-cochlear administration was well tolerated. The Committee recommended that Audiogene proceeds as planned with the assessment of the second dose which is the escalation part of the trial. Sensorion announced the completion of recruitment of the first cohort of three patients (toddlers and infants aged 6 to 31 months) on December 27, 2024. Recruitment of the second cohort (three patients) is due to be completed by the end of the first half of 2025.
The Audiogene trial is designed to evaluate the safety, tolerability and efficacy of intra-cochlear injection of SENS-501 for the treatment of OTOF gene-mediated hearing loss in paediatric patients aged between 6 and 31 months at the time of gene therapy treatment. By targeting the first years of life, when brain plasticity is at its peak, the chances of these young children with pre-linguistic hearing loss of acquiring normal speech and language are maximised. The trial is comprised of two cohorts of two doses followed by an expansion cohort at the selected dose.