Groundbreaking Phase 3 Trial for AWKN-001 Marks Major Milestone in Alcohol Use Disorder Treatment

Awakn Life Sciences has reached a significant checkpoint in its clinical development program, with the first patient now enrolled in the MORE-KARE Phase 3 trial investigating AWKN-001 as a treatment for severe alcohol use disorder (AUD). This represents a critical advancement in addressing a substantial gap in addiction medicine, where existing therapies demonstrate limited long-term effectiveness.

Understanding the Clinical Challenge

Approximately 29 million adults in the United States struggle with AUD, with comparable figures of around 40 million across North American and major European markets. Despite the high prevalence, current treatment approaches show disappointing outcomes: roughly 75% of patients return to harmful drinking patterns within 12 months of completing treatment. The direct economic burden in the US alone reaches approximately $249 billion annually, expanding to an estimated $472 billion when accounting for impacts across key European nations. This treatment gap has created an urgent need for innovative therapeutic approaches.

AWKN-001: A Dual-Action Approach

AWKN-001 represents a medication-assisted treatment combining ketamine—an N-methyl-D-aspartate receptor-modulating agent administered intravenously—with structured psychosocial support. Rather than relying solely on pharmaceutical intervention, the treatment protocol emphasizes integrating evidence-based psychological therapy with pharmacological support. This combined methodology distinguishes AWKN-001 from conventional addiction treatments that typically address either the biological or psychological dimensions in isolation.

Previous Phase 2 data provided compelling evidence for this approach, demonstrating an 86% abstinence rate at the six-month mark post-treatment, compared to only 2% before trial enrollment. Participants also showed a 50% reduction in heavy drinking days relative to placebo control groups—a meaningful clinical indicator for recovery outcomes.

The MORE-KARE Trial Design and Scope

The Multicentre Investigation of Ketamine for Reduction of Alcohol Relapse (MORE-KARE) stands as the largest ketamine-assisted therapy trial for AUD ever conducted globally. The research unfolds across eight National Health Service sites throughout the United Kingdom, with participant assignment to treatment arms determined by computer-randomized protocols. Both participants and clinical staff remain blinded to dose allocation and psychological support type throughout the study.

The trial’s primary assessment focuses on reduction in heavy drinking days during the six-month period following treatment completion. Secondary measures include continuous abstinence rates and the proportion of days with heavy alcohol consumption at the six-month follow-up. Researchers will employ drink diaries and daily breathalyzer self-assessments, with clinical evaluations scheduled at three and six months post-treatment.

Funding and Institutional Support

The trial carries a projected cost of £2.4 million (approximately CAD 4.2 million), with Awakn Life Sciences contributing £0.8 million (CAD 1.4 million). Funding partnership involves the UK’s Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) through their Efficacy and Mechanism Evaluation Programme. The University of Exeter serves as trial sponsor, with the Exeter Clinical Trials Unit managing overall coordination, data management, and statistical analysis.

Clinical and Scientific Perspective

According to Professor Celia Morgan from the University of Exeter, who leads the trial: “More than half a million UK adults require treatment for serious alcohol problems, yet only one in five actually receive it. Current standard interventions demonstrate low success rates—approximately three in four individuals who achieve sobriety resume heavy drinking within a year. This investigation addresses a critical therapeutic void in our quest for more effective interventions. The collaborative support from NIHR and Awakn Life Sciences enables what represents the largest international study examining ketamine combined with psychological therapy.”

Awakn’s Chief Scientific Officer, Professor David Nutt, added: “This clinical investigation has potential to reshape how we treat severe AUD, offering meaningful hope to patients with currently limited alternatives. The combination of ketamine with structured psychological support represents a promising direction for the field.”

About the Organizations

Awakn Life Sciences Corp. is a clinical-stage biotechnology enterprise developing therapies targeting substance use and mental health conditions, with near-term emphasis on AUD treatment. The company operates across Canadian Securities Exchange (CSE: AWKN), over-the-counter markets (OTCQB: AWKNF), and Frankfurt Stock Exchange (FSE: 954).

University of Exeter combines educational excellence with world-class research infrastructure, maintaining membership in the Russell Group of research-intensive institutions.

National Institute for Health and Care Research (NIHR) advances health outcomes through rigorous research funding, infrastructure investment, workforce development, and international collaboration to address complex healthcare challenges.