Phase III Trial will Assess Ketamine-Assisted Therapy for The Treatment of Severe Alcohol Use Disorder
TORONTO, CANADA, 18 April, 2023 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company developing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces 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 treat 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).
Anthony Tennyson Awakn CEO added “We are delighted to formalize an even stronger working collaboration and agreement with the University of Exeter particularly when this gives such a clear roadmap for our Phase III. 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.”
About Awakn Life Sciences Corp.
Awakn Life Sciences Corp. is a biotechnology company developing therapeutics to treat addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 285m people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels.
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Anthony Tennyson, CEO, Awakn Life Sciences
Gordo Whittaker, CMO, Awakn Life Sciences