Awakn Life Sciences Corp. announced that it has received clinical trial authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) and ethical approval from the Health Research Authority in the UK for a phase III clinical trial for its lead program AWKN-P001 for the treatment of Severe Alcohol Use Disorder (SAUD). SAUD, the most acute type of alcohol use disorder, affecting approximately 12.5 million people in the US and the key European markets of Germany, UK, France, Italy, and Spain.

AWKN-P001 is a novel combined therapeutic of a N-methyl-D-aspartate receptor-modulating drug (ketamine) used in combination with psycho- social support to treat SAUD. Results from AWKN-P001 phase II study were very positive, achieving 86% abstinence in the 6 months post treatments vs. 2% abstinence pre-trial, and 25% abstinence in current standard of care.

The trial is being funded by Awakn, The University of Exeter, and a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC). The phase III trial will be a 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 approx. GBP PS800,000 towards the costs of the trial, with the NIHR, the MRC, and the University of Exeter contributing the balance of the costs. The MHRA and Health Research Authority's approval and continued support reflects their confidence in the rigorous research, ethical standards and promise of this trial.

Enrollment for the phase III is due to start in First Quarter 2024.