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AWKN-P001
About AWKN-P001
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-P001 into a licensed therapeutic to treat SAUD and establish regulatory precedent for drug plus psycho-social support to treat addiction
Status:
- Phase II complete. Phase III trial in planning.Awakn awarded an ILAP innovation passport from the MHRA
- Grant awarded by UK Dept. for majority of the trial’s costs. Awakn’s cost capped at approx. US$1m
Near-term Catalysts:
- Regulatory and ethical approval H2 2023.
- Phase III first participant forecast for Q4 2023/Q1 2024.
AWKN-P001 TIMELINE
AWKN-P001 Phase III Trial Design
- • Tripartite partnership: Awakn, University of Exeter, UK Dept. of Health (NIHR & NHS)
- • n=280 two-armed placebo-controlled trial
- • Nine NHS Trust Sites
- • Program initiation March 2023
- • First participant forecast Dec 2023
AWKN-P001 Phase III Trial Design
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