Autifony Therapeutics announces initiation of Phase IIa study for first-in-class drug to treat tinnitus
The study will be conducted in 12 key hospital sites across the UK. Professor Jaydip Ray, ENT Surgeon at Sheffield Teaching Hospitals and Sheffield Children’s Hospital, will be the national Coordinating Investigator, with Professor Deborah Hall at The University of Nottingham and National Institute for Health Research (NIHR) Nottingham Hearing Biomedical Research Unit (BRU) as lead academic collaborator. The study is co-funded by a UK government-backed Biomedical Catalyst award.
In the earlier Phase I study, AUT00063 showed a good safety and tolerability profile, and pharmacokinetics compatible with once daily oral dosing. The Phase IIa study will focus in particular on tinnitus associated with hearing loss following noise exposure or ageing. Subjects will undergo four weeks of once daily dosing.
AUT00063 is also in development for the treatment of age-related hearing loss and a Phase IIa clinical trial in this indication is expected to start soon in the US.
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