UK biotechnology company Autifony Thereputics has been awarded £2.2 million by the government’s innovation agency to develop a new tinnitus drug.
Autifony Therapeutics, a UK-based biotechnology company, has announced that it has been awarded funding of £2.2 million by the UK government’s innovation agency, the Technology Strategy Board (TSB), to support a Phase 2 clinical trial in tinnitus patients of its new lead compound AUT00063. The clinical trial which is planned to start later in the year, will be carried out in the UK in collaboration with The University of Nottingham and National Institute for Health Research (NIHR) Nottingham Hearing Biomedical Research Unit (BRU).
Tinnitus can be caused by several different events (loud noise, toxins, infection) and the nature of the tinnitus can be very different between individuals. Research is on-going to increase our understanding of the biological mechanisms of different types of tinnitus so that new treatments can be developed, but it is thought that tinnitus caused by trauma to the ear (such as loud noise) starts with damage to the sensory cells and nerves in the inner ear (cochlea). This ear damage causes a loss of signal to the auditory system and the brain tries to compensate for this by increasing the electrical activity of certain nerves in order to ‘turn up the volume’. This change in nerve activity is thought to result in the ‘phantom noise’ of tinnitus.
The new drug being developed aims to reverse this change in tinnitus-related nerve activity. AUT00063 acts on channels, called Kv3 channels, in the cell membranes of particular types of nerve cells. Kv3 channels allow potassium ions to enter cells, and they are essential for the very rapid and accurate electrical firing of a specific type of neuron in the auditory system of the brain. Altered activity of these types of neurons has been implicated in the generation of tinnitus caused by noise exposure. By using AUT00063 to correct the activity of these neurons, the clinical researchers hope to reverse this early stage of tinnitus development and prevent longer term tinnitus-related changes in the brain.
Before a drug can be made available to the public it has to go through different stages (called Phases) of clinical trials in people to test whether it is safe and effective. Clinicians use clinical trials to see if the new treatment really does work better than a dummy treatment, if it has any dangerous side-effects and if it can be safely used over a long period and alongside other medications.
AUT00063 has already successfully completed Phase I clinical trials where the drug was tested for the first time in a small number of people – more than 60 young and elderly healthy volunteers. In this study the drug appeared safe and well tolerated by the volunteers, and no serious adverse events were recorded. The Phase 1 results together with the TSB funding award have paved the way for AUT00063 to be tested for the first time in tinnitus patients in a Phase 2 study planned to start later in the year.