Decibel Therapeutics Reports Third Quarter 2021 Financial Results and Corporate Update – GlobeNewswire
– Received Orphan Drug and Rare Pediatric Disease designations for DB-OTO for the treatment of otoferlin-related congenital hearing loss –
– On track for key 2022 milestones including submission of IND and/or CTA for DB-OTO and interim analysis of DB-020 Phase 1b trial for cisplatin-induced hearing loss –
– Announces AAV.104 gene therapy program for restoration of hearing in patients with congenital hearing impairment due to re…….
– Received Orphan Drug and Rare Pediatric Disease designations for DB-OTO for the treatment of otoferlin-related congenital hearing loss –
– On track for key 2022 milestones including submission of IND and/or CTA for DB-OTO and interim analysis of DB-020 Phase 1b trial for cisplatin-induced hearing loss –
– Announces AAV.104 gene therapy program for restoration of hearing in patients with congenital hearing impairment due to recessive mutations in the stereocilin gene –
BOSTON, Nov. 10, 2021 (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 third quarter ended September 30, 2021 and provided a corporate update.
“Decibel continues to work towards bringing transformative treatments to patients with hearing and balance disorders as we move to the end of a successful 2021 and look forward to 2022. We remain on track to initiate a Phase 1/2 clinical trial of DB-OTO in pediatric patients in 2022 and report the results of an interim analysis of our Phase 1b clinical trial of DB-020 in patients receiving cisplatin chemotherapy in the first half of 2022,” said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. “We are incredibly pleased to have received Orphan Drug and Rare Pediatric Disease designations for DB-OTO, reiterating the importance of our approach to gene therapies for congenital, monogenic hearing loss. Beyond DB-OTO, we have continued to leverage our precision gene therapy platform to advance our GJB2, stereocilin and regeneration gene therapy programs.”
Gene Therapies for Congenital, Monogenic Hearing Loss
- Received Orphan Drug and Rare Pediatric Disease Designations for DB-OTO: In September 2021, Decibel announced that the U.S. Food and Drug Administration (FDA) granted both Orphan Drug Designation and Rare Pediatric Disease Designation for DB-OTO for the treatment of otoferlin-related congenital hearing loss.
- On Track to Achieve DB-OTO Key Milestones in 2022: Decibel expects to submit an investigational new drug application (IND) with the FDA and/or a Clinical Trial Application (CTA) in Europe for DB-OTO and initiate a Phase 1/2 clinical trial of DB-OTO for pediatric patients with congenital hearing loss due to an otoferlin deficiency in 2022.
- Announces AAV.104 Gene Therapy Program for Restoration of Hearing in Patients with Congenital Hearing Impairment Due to Recessive Mutations in the Stereocilin (STRC) Gene: AAV.104 aims to restore hearing to individuals with a STRC deficiency, the second most common cause of autosomal recessive, non-syndromic, congenital hearing loss. The Company estimates that the prevalence of individuals with this form of hearing loss in the United States and the major markets in Europe is approximately 70,000. STRC is a large, extracellular, structural protein expressed in outer hair cells of the cochlea. Functional outer hair cells amplify sound …….
