Awakn Life Sciences Corp. announced that it has signed a collaboration agreement with the University of Exeter (UoE) putting in place a framework for the upcoming Phase III trial exploring the use of ketamine-assisted therapy to treat Severe AUD. The agreement formalizes the design, budget, and Awakn's contribution to the cost of the trial.

The trial will be a Phase III, n=280, two-armed, randomized, placebo-controlled trial. It will be delivered in the UK across ten UK National Health Service (NHS) sites. 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 the largest ketamine-assisted psychological therapy clinical trial to date and the only Phase III psychedelic clinical trial to receive government funding. If the results of the Phase III are positive, Awakn plans in due course to apply for marketing authorization for ketamine-assisted therapy to treating severe AUD. Professor Celia Morgan, Professor of Psychopharmacology at UoE and Awakn's Head of Ketamine-Assisted Therapy, will lead the trial, which follows on from 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 programs, 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).