Awakn Expands Phase 3 Trial of AWKN-001 for Severe Alcohol Use Disorder with New Sites
Key Insights
Awakn Life Sciences has broadened its Phase 3 trial for AWKN-001, a treatment for severe Alcohol Use Disorder (search) (AUD), by adding four new clinical trial sites in the UK.
The MORE-KARE trial will assess the efficacy of AWKN-001, which combines intravenous ketamine with psychosocial support, aiming to reduce alcohol relapse in severe AUD patients.
This pivotal study, co-funded by the UK's Medical Research Council and Awakn, is the largest of its kind to investigate ketamine-assisted therapy for AUD.
Awakn Life Sciences Corp. (search) has announced the opening of four additional clinical trial sites in the UK for its Phase 3 'MORE-KARE' trial of AWKN-001, an investigational treatment for severe Alcohol Use Disorder (search) (AUD). The expansion aims to accelerate the evaluation of AWKN-001's efficacy in reducing alcohol relapse, potentially offering a novel treatment pathway for individuals suffering from severe AUD.
The newly added trial sites include University Hospitals Sussex NHS Foundation Trust, South London and Maudsley NHS Foundation Trust, Greater Manchester Mental Health NHS Foundation Trust, and University Hospitals Plymouth NHS Trust. This brings the total number of active trial sites to seven across the UK.
AWKN-001: A Novel Approach to AUD Treatment
AWKN-001 is a medication-assisted treatment that combines intravenous (IV) ketamine, an N-methyl-D-aspartate (NMDA) receptor-modulating drug, with manualized psycho-social support. This dual approach aims to address both the physiological and psychological aspects of severe AUD.
The MORE-KARE study, short for Multicentre Investigation of Ketamine for Reduction of Alcohol Relapse, is co-funded by a partnership between the UK's Medical Research Council (MRC), the National Institute for Health and Care Research (NIHR), and Awakn Life Sciences Corp. (search) The Exeter Clinical Trials Unit at the University of Exeter manages the trial.
Trial Design and Objectives
The Phase 3 trial is designed to evaluate the efficacy of a single treatment cycle of AWKN-001. Participants are randomly assigned to different trial arms, receiving varying doses of ketamine infusion alongside psycho-social support sessions from a therapist. The specific dose and type of psychological support are randomly assigned by a computer, and both participants and the research team are blinded to the assigned dose/support.
Anthony Tennyson, CEO of Awakn, stated, "The expansion of trial sites marks a significant milestone in our mission to address the pressing need for innovative treatments for AUD...offering them a novel, more effective treatment pathway."
Prof. David Nutt, Chief Research Officer of Awakn, added, "The opening of these additional sites accelerates our ability to gather robust clinical data, essential for bringing this groundbreaking treatment to more patients."
Prior Efficacy Data
AWKN-001 has demonstrated promising results in a Phase 2 trial, achieving 86% abstinence on average over the 6 months post-treatment versus 2% pre-trial. The trial also showed a 50% reduction in Heavy Drinking Days versus placebo.
The total cost of the MORE-KARE trial 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.