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Also known as Otarmeni™, Otoferlin
DB-OTO · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| DB-OTO - Part A | EXPERIMENTAL | Unilateral intracochlear dosing |
| DB-OTO - Part B | EXPERIMENTAL | Bilateral intracochlear dosing using the dose selected based on safety and efficacy data from Part A |
| DB-OTO - Part C | EXPERIMENTAL | Unilateral or bilateral intracochlear dosing |
| Name | Type | Description |
|---|---|---|
| DB-OTO | GENETIC | Administered per the protocol |
Key Inclusion Criteria: 1. Willingness to provide written informed consent (by at least one parent/legal guardian for pediatric participants, and with participant to provide assent, when applicable, or by the adult participant) and willingness to comply with trial protocol 2. Willingness to consent...
DB-OTO is an investigational gene therapy being developed for congenital hearing loss secondary to biallelic mutations of the otoferlin gene (OTOF). It is intended for children, infants, adolescents, and adults with hearing loss caused by these specific genetic mutations.
DB-OTO targets the OTOF gene, which encodes otoferlin, a protein essential for normal hearing. The therapy is designed to address hearing loss caused by biallelic mutations in this gene by delivering a functional copy of the gene.
DB-OTO is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN.
DB-OTO is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants.
DB-OTO is being studied in a Phase 1 clinical trial with the identifier NCT05788536. This trial is recruiting an estimated 36 participants across the United States, Germany, Japan, Spain, and the United Kingdom.
Yes, DB-OTO is an adeno-associated virus (AAV) based gene therapy. It is designed to deliver a functional OTOF gene to address hearing loss caused by mutations in that gene.