Decibel Therapeutics receives European ODD for DB-OTO

Decibel Therapeutics announced that the European Medicines Agency, EMA, Committee on Orphan Medicinal Products, COMP, has issued a positive opinion on orphan drug designation, ODD, for DB-OTO, Decibel’s lead gene therapy product candidate designed to provide durable, high quality, physiological hearing to individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. This opinion was adopted by the European Commission, EC. "We are pleased to receive this important designation from the EC, which supports our conviction that innovative treatments for congenital hearing loss are urgently needed," said Laurence Reid, Ph.D., Chief Executive Officer at Decibel. "Decibel has generated compelling preclinical data showing DB-OTO’s potential, and we are on track to initiate CHORD(TM), our global Phase 1/2 clinical trial of DB-OTO, in the first half of this year."