Autifony is a company that was formed when a drug program was spun out of GlaxoSmithKline a few years ago and it has now announced positive results for a Phase 1 Clinical Trial on a new medication for schizophrenia. While its still very early in the drug development process, its always good to hear about new potential treatments for schizophrenia. Details below:
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.
More information:
http://www.autifonytherapeutics.com/autifony-science.asp#schizophrenia
Pfizer-backed GSK spinout advances schizophrenia drug following PhI success
London, U.K.-based Autifony spun out of GlaxoSmithKline ($GSK) in 2011 to develop an age-related hearing loss program, before branching out into schizophrenia in response to evidence that Kv3 voltage-gated potassium channels play a role in the disease. Pfizer’s ($PFE) VC wing, SV Life Sciences and other investors handed Autifony £8 million ($10.5 million) to explore this idea last year, giving the company the financial means to push AUT00206 through the Phase I trial.
The single-site, double-blind, randomized, placebo-controlled study featured two parts. In the first stage, participants, who were either fasting or fed, received up to 5 single doses of AUT00206 or a placebo. The second stage was a multiple ascending dose study.
Autifony has exited the Phase I trial with data it thinks show AUT00206 is safe, well tolerated and has pharmacokinetics capable of supporting clinically effective concentrations of the drug. Armed with the data, Autifony is pushing ahead with a pair of Phase Ib trials designed to give it a clearer picture of whether the effects it has seen in preclinical translate into the clinic.