Clinical Trials

* On November 20, 2014, Autifony Therapeutics announced that it has initiated a Phase IIa study in tinnitus subjects with 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. 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.

* On June 4, 2013, Autifony Therapeutics has initiated Phase I trial of AUT00063 for treatment of hearing loss and tinnitus. The study, being conducted in the UK, will investigate the safety and optimal dosing regimens of AUT00063 in around 60 young and elderly volunteers, and is expected to complete in Q1 2014.