Autifony Therapeutics, which is pioneering the development of novel pharmaceutical treatments for hearing loss and other serious brain disorders, has started phase I clinical evaluation of its second Kv3 modulator, AUT00206.

The evaluation marks the first time that a Kv3 modulation mechanism has been applied to the treatment of schizophrenia. AUT00206 represents a novel class of Kv3 modulator that is being developed specifically for schizophrenia and related indications. 

Kv3 ion channels are implicated in brain circuits which are believed to be dysfunctional in schizophrenia. The serious psychiatric illness has seen diminishing investment in research in recent years, and yet remains an area of high unmet need, with existing treatments often not delivering the desired efficacy and safety. The condition continues to impose a major social and economic burden. 

The first-in-human phase I study initiated by Autifony is a randomized, placebo-controlled ascending dose group trial that is being conducted in the U.K. It will investigate the safety, tolerability and pharmacokinetics of orally administered single and multiple doses of AUT00206 in healthy volunteers in fed and fasted states. A variety of biomarkers will be evaluated to explore pharmacodynamic activity.

The study is expected to complete in Q2 2016 and will be followed by two experimental medicine studies in human volunteers and patients. The program is supported by the Biomedical Catalyst, jointly funded by Innovate U.K. and the Medical Research Council, which also contributed important enabling funding toward the preclinical stages of the program, in collaboration with the Universities of Manchester and Newcastle.

Dr. Charles Large, chief executive officer of Autifony Therapeutics, said, “We are delighted that Autifony now has a second program in clinical trials. We believe that AUT00206 has the potential to be a real breakthrough in the treatment of schizophrenia. Preclinical results relevant to aspects of the disease strongly support the potential efficacy of AUT00206 in patients with schizophrenia, with fewer side effects than the current standard of care. We aim to progress this new drug as quickly as we can, to meet the high level of patient need.”

Autifony Therapeutics is an independent U.K.-based biotechnology company formed in 2011 as a spin-out from GSK, which retains equity in the company. The company is funded by SV Life Sciences, Imperial Innovations, Pfizer Venture Investments, International Biotechnology Trust and UCL Business.