Sensorion Reports Data in the Audiogene Phase 1/2 Gene Therapy Clinical Trial

In This Article:

  • SENS-501 gene therapy product and surgical procedure are well tolerated by the first two treated patients and encouraging behavioural changes are observed in both toddlers

  • Sensorion plans on hosting a KOL event in early 2025 to further comment and discuss the first cohort safety data, qualitative and quantitative efficacy measurements, and next steps for Audiogene Phase 1/2 clinical trial, including planned interactions with the U.S. Food and Drug Administration.

MONTPELLIER, France, December 18, 2024--(BUSINESS WIRE)--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, announced today latest data updates confirming the safety of SENS-501 in the two first patients injected in the Company’s Audiogene study. This is a Phase 1/2 clinical trial evaluating SENS-501 in patients aged 6 to 31 months and naïve of cochlear implant, who are suffering from a specific form of congenital deafness linked to mutations in the OTOF (otoferlin) gene.

The Audiogene clinical trial assesses, as primary endpoint in the first part of the dose escalation study, the safety of an intra-cochlear injection of SENS-501 in infants and toddlers aged 6 to 31 months at the time of gene therapy treatment. Sensorion’s objective in targeting the first years of life, when brain plasticity is optimal, is to maximize the chances of these young children with pre-linguistic hearing loss to acquire normal speech and language, thus, potentially transforming these toddlers’ lives. For the first two toddlers treated in the first cohort, SENS-501 gene therapy product and surgical procedure were well tolerated: the intra-cochlear administration of the gene therapy product was uneventful, and no serious adverse events were reported. In addition, encouraging behavioural improvements were observed in both toddlers. Sensorion plans on hosting a KOL event in early 2025 to further comment and discuss the first cohort safety data, qualitative and quantitative efficacy measurements, and next steps for Audiogene Phase 1/2 clinical trial, including planned interactions with the U.S. Food and Drug Administration. Further details regarding the event shall be disclosed in due course.

The Company continues to anticipate the completion of the first cohort enrollment by the end of the year and the recruitment of the second cohort by the end of H1 2025.

Géraldine Honnet, M.D., Chief Medical Officer of Sensorion, said: "I’m very pleased with the progress made in the Audiogene Phase 1/2 clinical trial evaluating SENS-501, a potentially game changing hearing loss therapeutic being developed in collaboration with the Institut Pasteur. Today’s data results confirm an excellent safety profile for the first toddlers treated with SENS-501 and I am happy to report early signs of encouraging behavioural changes in both patients. We look forward to treating the third patient of the first cohort imminently, thus achieving an important development milestone for Sensorion. We will host a KOL call in early 2025 and I am looking forward to presenting further safety and efficacy data for patients included in our first cohort.