Autifony Therapeutics announces initiation of Phase IIa study for first-in-class drug to treat tinnitus
Autifony Therapeutics Limited, which is pioneering the development of novel pharmaceutical treatments for hearing disorders, announced that it has initiated a Phase IIa study in tinnitus subjects with its lead compound AUT00063. This proof of concept study (called the QUIET-1 study, QUest In Eliminating Tinnitus) will explore the potential of AUT00063, Autifony’s first-in-class Kv3 potassium channel modulator, to reduce the symptoms of tinnitus, which is an area of significant unmet medical need.
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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