Autifony Therapeutics wins £2.2m of funding for a clinical trial of lead compound in tinnitus patients

Autifony Therapeutics, a UK developer of novel pharmaceutical treatments for hearing disorders, has been awarded funding of £2.2m towards a Phase IIa clinical trial in tinnitus patients with its lead compound AUT00063, by the UK’s Technology Strategy Board.

Autifony will sponsor the clinical study, with Professor Deborah Hall at The University of Nottingham and the National Institute for Health Research (NIHR) Nottingham Hearing Biomedical Research Unit (BRU) as the leading academic collaborator.

AUT00063 is a Kv3 potassium channel modulator in development for the treatment of age-related hearing loss, for which a Phase IIa clinical trial is expected to start later this year.

The Technology Strategy Board funding will enable Autifony to initiate a randomised, placebo controlled study in patients with tinnitus in the UK, allowing the company to test the drug’s efficacy in this poorly served patient group.

We are very hopeful that our pioneering Kv3 channel modulator approach may be able to bring some relief to patients with tinnitus

The award follows an application to the Biomedical Catalyst, jointly funded by the Technology Strategy Board and the Medical Research Council, and comes after the recent successful completion of a Phase I study, also conducted in the UK, which investigated the safety, tolerability and pharmacokinetics of orally administered single and multiple dose regimens of AUT00063 in more than 60 young and elderly healthy volunteers.

In the study the drug appeared safe and well tolerated, and no serious adverse events were recorded. The drug also showed excellent pharmacokinetics, compatible with once/daily oral dosing.

In addition the Phase I trial explored a variety of novel pharmacodynamic endpoints and interactions, which confirmed the engagement of the drug with the Kv3 ion channel target, and provided further supporting evidence for dose selection in the Phase II studies.

Dr Charles Large, Chief Executive of Autifony, said: 'Tinnitus seriously impacts quality of life for up to 1% of people, disrupting sleep and concentration, as well as affecting their hearing and emotional state. We are very hopeful that our pioneering Kv3 channel modulator approach may be able to bring some relief to patients with tinnitus, although there is clearly still a long development path ahead of us. The Technology Strategy Board funding will be very helpful in enabling us to test AUT00063 in this additional indication with such high unmet medical need.'

Dr Ralph Holme, Head of Biomedical Research at Action on Hearing Loss, the UK charity dedicated to hearing loss research, added: 'On a daily basis we are contacted by people who struggle to cope with their tinnitus and want to know if there are effective treatments for this condition. We are delighted that Autifony, with whom we have worked closely from its inception, has secured funding to continue clinical testing on a potential new drug treatment that we hope will bring relief to sufferers.'