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Overview
How Awakn’s psychedelic Medication-Assisted Treatments work
Existing addiction medicines target drug receptors in the brain, to reduce symptoms such as cravings. These have low long-term success rates for substance addiction, and offer no solution to behavioural addiction.
Our approach is different, delivering profound and long lasting changes over a single course of treatment.
Addiction – like anxiety, depression, and PTSD – is based on patterns of behaviour established in the brain.
Our Medication-Assisted Treatments disrupt the brain circuits that underlie these unhelpful patterns. They weaken neural connections linked to harmful thought patterns, opening the door for clients to rewrite constructive alternatives. By focusing on circuit mechanisms, not receptors, our approach has potential to work in behavioural addictions such as gambling, and for mental health conditions.
Through inducing these conditions that allow relearning of emotional responses, our psychotherapists can engage clients with root causes of their addiction.
This is an entirely new paradigm for mental health, where we are moving from palliative care towards permanent cure.
Therapeutic Development Pipeline
AWKN-001
AWKN-001 - is a novel MAT consisting of racemic ketamine, delivered Intravenously (IV) and manualized relapse prevention cognitive behavioural therapy (CBT) to treat severe Alcohol Use Disorder (SAUD) in the UK.
Ph2 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.
Ph3 enrolment is due to start in Q1 2024.
AWKN-002
AWKN-002 is a novel MAT consisting of a patent pending proprietary S–ketamine oral thin film (OTF) and manualized relapse prevention CBT to treat AUD in the US.
Ph1 was successful completed by LTS Lohmann and in-licensed by Awakn with safety established.
MDMA/Zydis
MDMA, an investigational medicinal product (IMP), is an entactogen that acts as a releaser and reuptake inhibitor of serotonin, norepinephrine (NE), and dopamine. MDMA has demonstrated potential efficacy in clinical trials to treat AUD and Post Traumatic Stress Disorder (PTSD), However, challenge exists to the successful development of MDMA as a marketed drug: excessive treatment duration of 6 to 8 hours; variable pharmacokinetics due to gastrointestinal absorption; and first-pass metabolism negatively effecting bioavailability.
Awakn is addressing these challenges by developing a market-ready proprietary formulation and optimized delivery route for MDMA on the Zydis platform.
Patents
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