Date: 2017-05-17
Type of
information: Initiation of the trial
phase: 1b
Announcement: initiation of the trial
Company: Autifony Therapeutics (UK)
Product: AUT00206
Action
mechanism: Kv3 potassium channel modulator
Disease: schizophrenia
Therapeutic
area: CNS diseases - Mental diseases
Country: UK
Trial
details: This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug. (NCT03164876)
Latest
news:
- • On May 18, 2017, Autifony Therapeutics announced the start of a Phase Ib biomarker study of the effect of AUT00206, a first-in-class Kv3 ion channel modulator, on patients with schizophrenia. The clinical trial is designed to test the safety, tolerability and pharmacokinetics of AUT00206 in patients with schizophrenia, and also explores the effects of AUT00206 on relevant central biomarkers. Twenty-four patients, diagnosed with schizophrenia within the last five years, will receive AUT00206 or placebo for 28 days. During that period, electrophysiological measures of central nervous function known to be impaired in schizophrenia will be investigated for signs of improvement. The subjects will also undergo brain imaging, tests of cognition and tests of auditory function, in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterise this range of biomarkers which will inform the future development of the drug.
- This project has been underpinned by a four-year collaboration with the Universities of Manchester and Newcastle, who have explored the effects of AUT00206 in preclinical models of brain pathophysiology relevant to schizophrenia. Another Phase Ib study of AUT00206 is already underway in healthy volunteers employing a ketamine challenge, in collaboration with Professor Bill Deakin at the University of Manchester.
- • On January 10, 2017, Autifony Therapeutics announced that a further Phase Ib study of AUT00206 in schizophrenia patients investigating clinical biomarkers of efficacy will soon be initiated, and 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.
Is
general: Yes
