Regeneron, Decibel's hearing loss gene therapy trial application gets approval in Spain
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- Decibel Therapeutics' (NASDAQ:DBTX) application to start a trial of its gene therapy DB-OTO to treat children with a type of hearing loss was approved in Spain.
- Spanish Agency of Medicines and Medical Devices approved the clinical trial application for DB-OTO, which is being developed with Regeneron Pharmaceuticals (NASDAQ:REGN) to provide durable, hearing in individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene.
- The drug has already received clearance to start a trial in the U.S. and the U.K.
- Decibel expects the trial participants in the U.K. and Spain will be infants two years of age and younger.
- The company hopes to report initial safety and efficacy data from the phase 1/2 trial, dubbed CHORD, in Q1 2024.
- DB-OTO has already received orphan drug and rare pediatric disease designations in the U.S., and orphan drug status in the EU.