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Regeneron Presents P-I/II (CHORD) Trial Data of DB-OTO for Profound Genetic Hearing Loss at Association for Research in Otolaryngology 2025

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  • Ongoing P-I/II (CHORD) trial assessed DB-OTO (intracochlear) in 12 pts (10mos.-16yrs.) with hearing loss due to variation in OTOF gene, where 9 pts received it in 1 ear, while 3 received it in both; pts enrolment (<18yrs.) ongoing in the US, UK & Spain
  • At 48 wks., first subject (10mos. old) showed improved hearing to near-normal levels (0.25–2.0 kHz) & depicted positive ABRs. Speech perception was also improved, with correct word recognition at 48–72wks.
  • 10/11 pts showed improved hearing at various dBHL in ≥1 post-therapy test. At 24wks., 3/5 pts improved to nearly normal (n=1, ≤40 dBHL) or normal (n=2, ≤25 dBHL) hearing levels with ABR aligning to PTA data, while 1/5 showed no change

Ref: Regeneron | Image: Regeneron

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