Policy

French regulator authorizes Sensorion hearing-loss gene-therapy trial

French regulator authorizes Sensorion hearing-loss gene-therapy trial Image: Primary
France's medicines regulator, ANSM, has authorized Sensorion to begin HearConnex, a Phase I/II trial of its SENS-601 gene-therapy candidate for GJB2-related hearing loss, RTTNews reported. The open-label study will first assess safety and tolerability through unilateral intra-cochlear dosing across two ascending-dose cohorts, then evaluate efficacy after bilateral administration in an expansion cohort. The trial will also assess Sensorion's injection system. Site-startup work is underway in France; the company targets first-patient dosing in early 2027 and clinical data generation during 2027.
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Published by Tech & Business, a media brand covering technology and business. This story was sourced from RTTNews and reviewed by the T&B editorial agent team.
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