Awakn Life Sciences Begins Patient Screening in MORE-KARE Phase 3 Trial

Awakn Life Sciences begins patient screening in MORE-KARE phase 3 trial of AWKN-001 for severe alcohol use disorder

Overview

Awakn Life Sciences Corp. (Awakn), a clinical-stage biotechnology company, announces that the first patient has been screened in the landmark ‘MORE-KARE’ phase 3 trial of AWKN-001 for severe alcohol use disorder (AUD).

About AWKN-001

AWKN-001 is an investigational, novel medication-assisted treatment for severe AUD, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support for severe AUD.

The MORE-KARE Study

The MORE-KARE study, or the multicentre investigation of ketamine for reduction of alcohol relapse, is co-funded by a partnership between the UK’s Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR), and Awakn Life Sciences Corp.?It is managed by the Exeter Clinical Trials Unit.

Trial Details 

• The phase 3 trial aims to evaluate the effectiveness of a single treatment cycle of AWKN-001.
• Participants will be randomly allocated into a trial arm, receiving different doses of ketamine infusion along with psycho-social support sessions from a trial therapist. 
• The specific dose and type of psychological support for each participant will be randomly assigned by a computer. 
• Both participants and the research team will be blinded to the assigned dose/support.

Primary Endpoint

• The primary endpoint is the reduction in heavy drinking days (HDD) over a six-month period post-treatment. 
• Secondary endpoints include continuous abstinence and the percentage of HDD at the six-month follow-up. 
• The effectiveness of the treatment will be assessed using drink diaries and daily self-administered breathalyser tests, with follow-up visits at three and six months.

This study is the largest of its kind investigating ketamine-assisted therapy for AUD. The total trial cost is estimated at £2.4 million/CAD 4.2 million, with Awakn contributing £0.8 million/CAD 1.4 million. The trial is being conducted at eight National Health Service (NHS) sites across the UK.

From the University of Exeter

• Trial lead Professor Celia Morgan, from the University of Exeter, said: “More than half a million UK adults have serious alcohol problems that require help, yet only one in five of those get treatment. Current treatments have low success rates - we know that three out of four people who quit alcohol will be back drinking heavily after a year.
• This new trial is helping to fill the gap in the urgent search for new treatments. We’re excited that the NIHR and Awakn Life Sciences have funded this study, which is the largest study of ketamine combined with psychological therapy to take place anywhere in the world.

CSO: Awakn

Awakn's chief scientific officer, Professor David Nutt, added: ""This trial could potentially revolutionize the treatment landscape for severe AUD, offering hope to those who currently have limited options. We're excited to see the impact of combining ketamine with structured psychological support.""

AWKN-001 is an investigational, novel medication-assisted treatment for severe AUD, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support in the UK market only.

About Phase 2 Trial

A phase 2 trial was successfully completed with efficacy proven, achieving 86% abstinence on average over the 6 months post-treatment versus 2% pre-trial and a 50% reduction in HDD versus placebo.

Phase 3 Trial Site

• A phase 3 clinical trial (MORE KARE) is being run by the University of Exeter with participant recruitment due to start in Q3 2024. 
• This trial is co-funded by the Efficacy and Mechanism Evaluation (EME) Programme - a partnership between the UK’s National Institute for Health Research (NIHR) and the Medical Research Council (MRC) - and Awakn Life Sciences Corp.

About AUD

• AUD is a chronic, relapsing brain health disorder characterised by compulsive alcohol use, loss of control over drinking, and negative emotional states when not using alcohol. 
• AUD affects approximately 29 million adults in the US and approximately 40 million in the US and key European markets. 
• Despite this high prevalence treatment success rates are very low with up to 75% of patients with AUD returning to harmful drinking within 12 months of treatment. 
• This creates a significant unmet medical need and a substantial public health concern, with enormous economic cost of approximately $249 billion in the US, rising to approximately US$ 472 billion when including key European markets.

Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting substance use and mental health disorders.

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