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Autifony Awarded £2.2 Million to Progress AUT00063 for Tinnitus into Phase IIa Study

Published: Wednesday, June 04, 2014
Last Updated: Wednesday, June 04, 2014
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Award follows successful completion of Phase I.

Autifony Therapeutics Limited has announced that it has been awarded funding of £2.2 million towards a Phase IIa clinical trial in tinnitus patients with its lead compound AUT00063, by the UK’s innovation agency, the Technology Strategy Board.

Autifony will be sponsor of the clinical study, 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.

AUT00063 is a first-in-class 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 award will now enable Autifony to initiate a randomized, placebo controlled Phase IIa study in patients with tinnitus in the UK, allowing Autifony to test the drug’s efficacy in this poorly served patient group.

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 randomized, placebo controlled Phase I study, 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. AUT00063 showed excellent pharmacokinetics, compatible with once/daily oral dosing.

The Phase I trial also 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 Officer of Autifony, commented: “There is a huge need for a drug to treat tinnitus, which is surprisingly common, affecting over 10% of the population. 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, commented: “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, who we have worked with closely from their inception, has secured funding to continue clinical testing on a potential new drug treatment that we hope will bring relief to tinnitus sufferers.”

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