Toronto, Ontario, January 7, 2024

Introduction: In a landmark step for addiction treatment, Awakn Life Sciences Corp. has received the green light to commence Phase III clinical trials for its pioneering treatment, AWKN-P001, targeting Severe Alcohol Use Disorder (SAUD).

The Innovation: AWKN-P001 combines a N-methyl-D-aspartate receptor-modulating drug, ketamine, with psycho-social support, demonstrating significant potential in treating SAUD. Phase II results were striking, showing an 86% abstinence rate post-treatment, a marked improvement over the 2% pre-trial rate and 25% in current standard care​​.

The Trial: Funded by Awakn, the University of Exeter, the National Institute for Health and Care Research (NIHR), and the Medical Research Council (MRC), the Phase III trial will be a randomized, placebo-controlled study across ten UK National Health Service (NHS) sites. The trial will enroll 280 participants, with Awakn contributing approximately GBP £800,000 toward its costs​​.

Expert Perspectives: Prof. Celia Morgan, Head of Ketamine-Assisted Therapy at Awakn, expressed enthusiasm about this "largest and most rigorous study of ketamine-assisted therapy for Alcohol addiction to date." Anthony Tennyson, Awakn CEO, emphasized the trial's significance in bridging cutting-edge science with commercially viable solutions for SAUD​​.

Conclusion: The MHRA and Health Research Authority's approval underlines their confidence in the trial's rigorous research and ethical standards, setting a new precedent in addiction therapy. Enrollment is expected to commence in Q1 2024, marking a critical step in addressing the challenges of SAUD