REGNRegeneron PharmaceuticalsSigning up patients
A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
5Calmworry score, out of 100
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
- +4.8
5 insiders sold shares within a month
Since Nov 4, 2026 · was worth 5, fading over time
Worry score5
Score over time
- Stage
- Phase 1/2
- Patients
- 36 (planned)
- Started
- Jun 27, 2023
- Main results expected
- Feb 26, 2029
- Fully finished
- Feb 25, 2032
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Measured over: Up to week 104
Achievement of a hearing sensitivity threshold of ≤70 dB assessed by average Pure Tone Audiometry (PTA)
Measured over: Up to week 104
Changes Tremor has spotted
No changes since Tremor started watching this trial.
Show details (technical version)
Score inputs
- insider_selling_cluster: base 5, now 4.8, since 2026-11-04, fades (half-life)
Raw record changes
- none yet
Trial ID NCT05788536 · record last updated 2026-08-05 · checked 2026-11-09 15:47 UTC