Autifony Therapeutics Limited has announced the start of a Phase I clinical study of the novel, first-in-class Kv3 potassium channel modulator, AUT00063.
This is a randomized, placebo controlled Phase I study, conducted in the UK, to investigate the safety, tolerability and pharmacokinetics of orally administered single and multiple dose regimens of AUT00063 in around 60 young and elderly volunteers.
The study, which is also exploring a variety of novel pharmacodynamic endpoints and interactions, is expected to be completed in Q1 2014.
AUT00063 is being developed as a treatment for age-related hearing loss and tinnitus. Despite the fact that 50% of those aged over 60 suffer from age-related hearing loss and 10% of the population suffer from some form of tinnitus, there are currently no effective treatments for either condition.
AUT00063 is a novel pharmaceutical that targets auditory processing in the brain. Deficits in these central mechanisms are believed to contribute to hearing difficulties in the elderly as well as the emergence of tinnitus.
To fund this lead programme through to clinical Proof-of-Concept for at least one hearing disorder indication, Autifony has also announced that Pfizer Venture Investments, the venture capital arm of Pfizer Inc., has invested £5 million to join existing investors SV Life Sciences, Imperial Innovations plc and UCL Business plc (UCL-B) in the Series A financing round.
Dr Elaine Jones from Pfizer has joined the Autifony board. The International Biotechnology Trust PLC (IBT) has also invested, bringing the total funds raised to date to £15.75 million.
Dr Charles Large, Chief Scientific Officer of Autifony Therapeutics, commented: “We are delighted by the progress that has been made to bring AUT00063 into clinical development. Hearing loss and tinnitus affect the lives of a vast proportion of the population, yet there are no effective treatments available. AUT00063 has the potential to change that.
“We welcome the financial commitment from Pfizer and IBT, in addition to SV Life Sciences, Imperial Innovations, and UCL-B, which will allow us to explore the therapeutic potential of this first-in-class medicine. Our current intent is to partner the programme, for which we hold unencumbered global rights, once we have achieved clinical proof of concept and we are encouraged by the interest shown to date by pharmaceutical companies.”