Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 designed to address hearing loss caused by mutations in this specific gene.
DB-OTO is an adeno-associated virus (AAV) based gene therapy. It is designed to deliver a functional copy of the otoferlin gene to target cells, with the goal of restoring hearing in patients with congenital hearing loss due to biallelic OTOF mutations.
DB-OTO is being developed by Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN). The company is conducting clinical trials to evaluate the safety and efficacy of this gene therapy for congenital hearing loss.
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 recruiting participants to assess the therapy.
DB-OTO is being studied in a Phase 1 clinical trial (NCT05788536), which is currently recruiting. The trial is evaluating DB-OTO in children, infants, adolescents, and adults with hearing loss due to otoferlin mutations, with an enrollment target of 36 participants.
Yes, DB-OTO is an adeno-associated virus (AAV) based gene therapy. It uses an AAV vector to deliver the therapeutic gene, and it is being investigated for the treatment of congenital hearing loss caused by biallelic otoferlin gene mutations.