Date: 2017-01-10
Type of
information: Results
phase: 1a
Announcement: results
Company: Autifony Therapeutics (UK)
Product: AUT00206
Action
mechanism: Kv3 potassium channel modulator.
Disease: schizophrenia
Therapeutic
area: CNS diseases - Mental diseases
Country: UK
Trial
details:
Latest
news:
- • On January 10, 2017, Autifony Therapeutics announced positive findings from a Phase Ia clinical trial of AUT00206, a first-in-class Kv3 modulator in development for the treatment of schizophrenia, as well as the start of the first of two Phase Ib studies with the molecule. The results of the Phase 1a study provide encouraging confirmation of human target engagement, and support progression of AUT00206 in schizophrenia. In particular, these biomarker findings provide the first clinical evidence for the hypothesis that modulating Kv3 channels has the potential to treat schizophrenia.
- The Phase Ia study in healthy volunteers assessed the effects of AUT00206 on Mismatch Negativity (MMN) latency. MMN latency increases have been associated with cognitive deficits in patients with schizophrenia and mild cognitive impairment. AUT00206 was associated with a significant reduction in MMN latency eight hours after dosing on Day 1. There was also a correlation between individual Cmax values (maximum concentration of AUT00206 in blood plasma) and MMN latency, which approached statistical significance. The biomarker evaluation was part of a Phase I study designed to assess the safety, tolerability and pharmacokinetics of AUT00206 in relation to dose in over 60 healthy volunteers, as reported on 1 August 2016. Single and multiple ascending oral doses of AUT00206 were evaluated in a double blind, randomised, placebo controlled clinical trial in the UK. AUT00206 was shown to be safe and very well tolerated, with plasma pharmacokinetics confirming drug concentrations at levels required to generate a clinical effect, as predicted by preclinical models. MMN and other measures of brain activity were evaluated in a subset of 32 healthy volunteers. The MMN latency changes were seen at doses and plasma concentrations that were shown to be safe and well tolerated.
- • On August 1, 2016, Autifony Therapeutics announced successful completion of a Phase I clinical evaluation of its Kv3 modulator, AUT00206. 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.
- • On November 24, 2015, Autifony Therapeutics announced the start of Phase I clinical evaluation of its second Kv3 modulator, AUT00206. This is the first time that a Kv3 modulation mechanism has been applied to the treatment of schizophrenia. 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 UK. 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 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
