Research & Development - Awakn Life Sciences

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Overview

Therapeutic Development Pipeline

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.

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AWKN-002

AWKN-002 is a novel MAT consisting of a patent pending proprietary esketamine oral thin film (OTF) and manualized psycho-social support for alcohol use disorder in the US.

Ph1 was successful completed by LTS Lohmann and in-licensed by Awakn.

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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.

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Aminoindane NCEs

Aminoindanes are a class of molecules that offer an alternative source of medical empathogens to MDMA for use alongside psycho-social support in the treatment of trauma related mental health disorders.

Aminoindanes have similar pharmacological properties to MDMA, they promote serotonin dopamine and noradrenaline release and block their reuptake. This combination of effects is believed to underpin the empathogenic activity. They offer a novel patentable approach to the treatment of trauma-related disorders.

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