Awakn Life Sciences Corp., a Toronto-based biotech firm, has received critical approvals to advance its pioneering treatment for Severe Alcohol Use Disorder (SAUD). The Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Health Research Authority have sanctioned a phase III clinical trial for AWKN-P001, a drug combining ketamine and psycho-social support.
This major development follows promising results from the phase II study, where abstinence rates among participants surged from 2% pre-trial to an impressive 86% following the treatments. The phase III trial is set to be the most comprehensive examination of ketamine-assisted therapy for alcohol addiction to date, with enrollment scheduled to commence in Q1 2024.
The trial will be a two-armed randomized placebo-controlled study involving 280 participants at ten UK National Health Service (NHS) sites. Funding for this significant research comes from a collaboration between Awakn, The University of Exeter, and a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC), with Awakn contributing approximately £800,000 towards the costs.
Prof. Celia Morgan, Head of Ketamine-Assisted Therapy at Awakn, highlighted the potential of AWKN-P001 to change the landscape of alcohol addiction treatment. CEO Anthony Tennyson expressed that the approval is a reflection of Awakn’s dedication to scientific rigor and improving patient well-being. The company’s overarching aim is to deliver innovative therapeutics to individuals grappling with addiction disorders, with a primary focus on AUD.
The endorsement by MHRA and ethical approval from the U.K.’s Health Research Authority underlines the significance of this phase III trial in Awakn’s commercial journey and its commitment to addressing the needs of nearly 12.5 million people affected by SAUD in the U.S. and key European markets.
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