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AWKN-001
About AWKN-001
AWKN-001 is a novel medication-assisted treatment for severe Alcohol Use Disorder, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support for severe alcohol use disorder in the UK market only.
AWKN-001 is in phase 3 planning. The phase 3 trial (“More Kare”) will be run by the University of Exeter and is co-funded by the UK National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation Programme (NIHR150193) and Awakn.
AWKN-001 phase 2 was successful completed with efficacy proven, achieving on 86% abstinence on average over the 6 months post treatment versus 2% pre-trial and a 50% reduction in heavy drinking days versus placebo.
Phase 3 enrolment is due to start in Q3 2024.
AWKN-001
Goal:
- Develop AWKN-001 into a licensed therapeutic to treat SAUD in the UK and establish regulatory precedent for drug plus manualized relapse prevention CBT to treat addiction
Status:
- Ph2 complete
- N=280 ph3 approved
- Enrolment due to commence in Q1 2024
- Grant awarded by UK Department of Health for majority of ph3 costs, Awakn’s cost capped at approx. US$1m
- UK MHRA ILAP designation secured
AWKN-001 TIMELINE
AWKN-001 Ph3 Trial Design
- • N=280 two-armed placebo-controlled trial
- • Run by the University of Exeter
- • Co-funded by the UK National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation Programme (NIHR150193) and Awakn.
- • Nine NHS Trust Sites
- • Enrolment expected to commence Q3 2024
AWKN-001 Phase III Trial Design
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