Decibel Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Update – BioSpace

– Key anticipated catalysts in 2022 include submission of IND and/or CTA for DB-OTO and results from interim analysis from Phase 1b trial of DB-020 for cisplatin-induced hearing loss –

– Research term extended under strategic collaboration with Regeneron to discover and develop gene therapies for hearing loss –

– Announced AAV.104 gene therapy program for restoration of hearing in patients with stereocilin-related hearing loss –

– Presented new preclinical data supporting continued progress of DB-OTO and importance of cell-selective transgene expression across gene therapy pipeline at the 45^th Annual Association for Research in Otolaryngology Conference (ARO) –

BOSTON, March 18, 2022 (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 reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update.

“In 2021, Decibel made significant progress across our pipeline and towards our goal to bring transformative treatments to patients with hearing and balance disorders. We are on track to meet a number of important milestones in 2022, including the initiation of the first clinical trial of our lead gene therapy candidate, DB-OTO, designed to treat congenital hearing loss resulting from an otoferlin deficiency,” said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. “Among the milestones expected in 2022, we look forward to reporting the results of the interim analysis of our Phase 1b clinical trial of DB-020 in patients receiving cisplatin chemotherapy. We were also pleased that our gene therapy research and development collaboration with Regeneron was extended, that we expanded our preclinical gene therapy pipeline, and that we augmented our excellent Board of Directors.”

Pipeline Highlights and Upcoming Milestones:

Gene Therapies for Congenital, Monogenic Hearing Loss        

• On Track to Achieve DB-OTO Key Milestones in 2022: Decibel expects to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration and/or a Clinical Trial Application (CTA) in Europe for DB-OTO in 2022. Decibel also anticipates initiating a Phase 1/2 clinical trial of DB-OTO for pediatric patients with congenital hearing loss due to an otoferlin deficiency in 2022.
• Presented New Preclinical Data at the 45^th Annual Association for Research in Otolaryngology Conference (ARO) for DB-OTO and AAV.104 Programs: In February 2022, Decibel presented preclinical DB-OTO data as well as preclinical data highlighting the identification of proprietary, cell-selective promoters for three of its gene therapy pipeline programs at ARO. New DB-OTO data further characterized expression of otoferlin over time following DB-OTO administration in mice and …….

  Source: https://www.biospace.com/article/releases/decibel-therapeutics-reports-fourth-quarter-and-full-year-2021-financial-results-and-corporate-update/

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