Decibel stock surges 18% as FDA clears hearing loss gene therapy to enter trial
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The U.S. Food and Drug Administration (FDA) granted clearance to Decibel Therapeutics' (NASDAQ:DBTX) investigational new drug (IND) application for starting a phase 1/2 trial of gene therapy DB-OTO to treat hearing loss in pediatric patients.
DB-OTO is aimed to provide durable hearing in individuals born with profound congenital hearing loss due to deficiency of a protein called otoferlin, according to the company.

Decibel said DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals (NASDAQ:REGN) and is an adeno-associated virus (AAV)-based gene therapy product candidate.
The company added that a one-time administration of DB-OTO had shown a production of otoferlin protein and durable auditory brainstem responses to sound in a congenitally deaf rodent disease model.
Decibel expects the first two participants in the U.S. portion of the phase 1/2 trial will be as young as seven years of age and afterwards will include children as young as two years of age, and infants below two years of age.
The company noted that DB-OTO is the second product candidate after DB-020 in its pipeline to advance into clinical testing.
DBTX +18.24% to $3.50 premarket Oct. 17