Autifony Therapeutics Limited (“Autifony”), which is pioneering the development of novel pharmaceutical treatments for hearing disorders and other serious disorders of the central nervous system, today announced successful completion of a Phase I clinical evaluation of its Kv3 modulator, AUT00206.
There have been few new approaches to treating schizophrenia in recent years, and with existing treatments often not delivering the desired efficacy and safety, there is strong interest in new mechanisms from both industry and academia. Modulation of Kv3 channels has the potential to treat schizophrenia patients early in the course of the disorder, with a much improved safety profile compared to current antipsychotic treatments. Evidence from preclinical models suggests that this novel approach may have the potential to treat cognitive and negative symptoms, as well as positive symptoms, which would represent a major breakthrough for patients. AUT00206 is a first-in-class Kv3 modulator that Autifony is progressing specifically for schizophrenia.
The Phase I study assessed the safety, tolerability and pharmacokinetics of AUT00206 in relation to dose in over 60 healthy volunteers. Double blind, randomised, placebo controlled single ascending dose and multiple ascending dose studies in fed and fasted states were conducted in the UK. AUT00206 was shown to be safe and very well tolerated, with pharmacokinetics confirming drug concentrations at levels required to generate a clinical effect, as predicted by preclinical models.
The next steps are two important Phase Ib clinical trials: a ketamine challenge study to be carried out by Professor Bill Deakin at the University of Manchester, which will translate an approach that demonstrated positive results in a preclinical model; and a study in schizophrenia patients investigating clinical biomarkers of efficacy, to be conducted in collaboration with Dr Oliver Howes at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) Kings College London. The programme is supported by the Biomedical Catalyst, jointly funded by Innovate UK and the Medical Research Council, who also contributed important enabling funding towards the preclinical stages of the programme, in collaboration with the Universities of Manchester and Newcastle.
Dr Charles Large, Chief Executive Officer of Autifony Therapeutics, commented:
“We are delighted that AUT00206 is showing such a promising profile. It’s widely recognized that there is a huge unmet need for new, more efficacious and safer treatments for schizophrenia. We believe AUT00206 has the potential to be a breakthrough for patients, and we will therefore continue to seek collaborative ways to expedite development of this exciting new drug.”