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.