UK-based biotechnology company Autifony Therapeutics (Autifony) has completed its Phase I clinical trial of Kv3 modulator, AUT00206, to treat schizophrenia.
AUT00206 is an orally administered, active small molecule developed to selectively modulate Kv3 potassium channels.
The double blind, randomised, placebo controlled, single ascending dose and multiple ascending dose Phase I trial has evaluated the safety, tolerability and pharmacokinetics profile of AUT00206 in more than 60 healthy volunteers.
Autifony CEO Dr Charles Large said: “We are delighted that AUT00206 is showing such a promising profile.
“It is widely recognised 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.”
It has been suggested that modulation of Kv3 channels can result in an early treatment of schizophrenia with an improved safety profile, compared to the contemporary antipsychotic treatments.
Preclinical models inform that the new approach can treat cognitive and negative symptoms, as well as positive symptoms related to the disorder.
AUT00206 was also demonstrated as safe and well tolerated, with pharmacokinetics aligned to the required drug concentrations levels, resulting in a clinical effect.
The company is planning to conduct two Phase Ib clinical trials, a ketamine challenge study and a study in schizophrenia patients to determine clinical biomarkers of efficacy.
Image: fMRI displaying normal brain control and a schizophrenic brain. Photo: courtesy of Kim J, Matthews NL, Park S.