Awakn Life Sciences and the University of Exeter (UoE) are collaborating to put in place a framework for a Phase 3 trial exploring the use of ketamine-assisted therapy to treat severe alcohol use disorder (AUD).
The trial will be the largest ketamine-assisted psychological therapy clinical trial to date and the only Phase 3 psychedelic clinical trial to receive government funding.
Awakn will contribute GBP £800,000 towards the costs of the trial, with the National Institute for Health and Care Research (NIHR), the Medical Research Council (MRC), and the University of Exeter contributing the balance of the costs.
The trial will be a Phase 3, n=280, two-armed randomised placebo-controlled trial, and will be delivered in the UK across ten UK National Health Service (NHS) sites.
Anthony Tennyson, Awakn CEO, commented: “We are delighted to formalise an even stronger working collaboration and agreement with the University of Exeter particularly when this gives such a clear roadmap for our Phase 3.
“We have been working side by side for several years now and they are a world-leading institute for research and a partner we are very happy to work with. We share the same vision of providing a new more effective treatment for AUD available to the millions of people who are in such desperate need for it.”
Professor Celia Morgan, Professor of Psychopharmacology at UoE and Awakn’s Head of Ketamine-Assisted Therapy will lead the trial, which follows the impressive results of the Phase II a/b trial announced in January 2022, which resulted in participants experiencing on average 86% abstinence at six-months post-treatment, versus 2% pre-trial.
In February 2023 Awakn received an Innovation passport as part of the Innovative Licensing and Access Pathway (ILAP) from the Medicine’s Health and Regulatory Authority (MHRA) the UK regulatory body, which aims to accelerate time to market for research programmes, much like the FDA’s fast track designation.
ILAP will allow Awakn a working collaboration with access to specialist advice from the MHRA and its partners, including the National Institute of Health and Care Excellence (NICE).
If the results of the trial are positive, Awakn plans to apply for marketing authorisation for ketamine-assisted therapy to treat severe AUD.
