![]() ![]() “Spain is an important country within our DB-OTO clinical development strategy, and our trial will leverage the collaborations and natural history work that we have pursued there over the past several years,” said Laurence Reid, Ph.D., Chief Executive Officer at Decibel. The Company anticipates reporting the initial safety and tolerability data and preliminary efficacy data, as measured by ABR, from the first patients in the Phase 1/2 clinical trial in the first quarter of 2024. and Spain will be infants two years of age and younger. Decibel expects that clinical trial participants in the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) in January 2023. The CTA in Spain is part of an international regulatory strategy for clinical development of DB-OTO, which also includes a regulatory clearance for an Investigational New Drug (IND) application in the United States in October 2022 and a CTA approval by the U.K. and is a cell-selective, adeno-associated virus (AAV) gene therapy product candidate designed to provide durable, physiological hearing in individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals, Inc. ![]() PDF Version CTA authorization provides approval for the Company to expand its planned CHORD™ Phase 1/2 clinical trial of DB-OTO to patients in Spain aged two years and youngerīOSTON, (GLOBE NEWSWIRE) - Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced approval of its Clinical Trial Application (CTA) by the Spanish Agency of Medicines and Medical Devices (AEMPS) to initiate a Phase 1/2 clinical trial in pediatric patients of DB-OTO, its lead gene therapy product candidate. ![]()
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