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DB-OTO gene therapy study in OTOF-related congenital hearing loss
2024-511342-40-00Phase 2Authorised
- Sponsor
- Regeneron Pharmaceuticals
- Start
- Mar 2024
- Modality
- Gene Therapies
- Countries
- 4
01
Overview
Phase 2, open-label trial of lunsotogene parvec in congenital hearing loss and sensorineural hearing loss (SNHL) (2 cohorts), sponsored by Regeneron Pharmaceuticals. Primary endpoints: Incidence and severity of treatment-emergent adverse events and Achievement of a hearing sensitivity threshold of ≤70 dB assessed by average pure tone audiometry. Planned start Mar 2024; status: authorised.
02
Drugs
lunsotogene parvec
03
Conditions
congenital hearing losssensorineural hearing loss (SNHL)
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