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AWKN-001
About AWKN-001
AWKN-P001 - is a novel combined therapeutic consisting of racemic ketamine, delivered IV, and specifically designed psycho-social support to treat Severe Alcohol Use Disorder.
Ketamine is an N-methyl-d-Asparate (NMDA) receptor antagonist with well-established safety and efficacy as an analgesic and anaesthetic. At sub-anaesthetic doses ketamine produces alterations in consciousness, disrupts memory reconsolidation, and delivers downstream neuroplasticity, which when combined with therapy has been proven by Awakn to significantly reduce the probability of relapse for Alcohol Use Disorder.
AWKN-P001 builds on Awakn’s successful phase II a/b clinical trial for ketamine-assisted therapy for Severe AUD in which participants in the active arm achieved 86% abstinence at 6 months post treatment versus 2% pre-trial and 25% in current standard of care.
AWKN-P001
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
- • Tripartite partnership: Awakn, University of Exeter, UK Dept. of Health (NIHR & NHS)
- • Jointly funded by Awakn and the NIHR Efficacy and Mechanism Evaluation (EME) Programme (NIHR150193), an MRC and NIHR
- • n=280 two-armed placebo-controlled trial
- • Nine NHS Trust Sites
- • Enrolment expected top commence Q1 2024
AWKN-001 Phase III Trial Design
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