Eli Lilly unit says participant in Phase 1/2 study had hearing restored

Akouos, a wholly owned subsidiary of Eli Lilly, announced “positive” initial clinical results from the Phase 1/2 AK-OTOF-101 study, which demonstrated pharmacologic hearing restoration within 30 days of AK-OTOF administration in the first participant, an individual with a decade-plus history of profound hearing loss. The first participant to receive AK-OTOF in the study, an 11-year-old at the time of AK-OTOF administration with profound hearing loss from birth, experienced restored hearing within 30 days of AK-OTOF administration, the company said in a statement. In this individual, hearing was restored across all tested frequencies, achieving thresholds of 65 to 20 dB HL, and within the normal hearing range at some frequencies at the day 30 visit. Both the surgical administration procedure and the investigational therapy were well tolerated, and no serious adverse events were reported, according to the company.