Awakn intends to run a Phase III trial for ‘Ketamine-Assisted Psychotherapy for Alcohol Use Disorder’
London, United Kingdom–(Newsfile Corp. – March 2, 2021) – Awakn Life Sciences Inc., a clinical-biotech company researching, developing, and delivering psychedelic medicine to treat addiction and other mental health conditions, today announced an exclusive license to use and deliver the ‘Ketamine in the Reduction of Alcoholic Relapse’ (KARE) psychotherapy intervention, as validated in a Phase II clinical trial led by the University of Exeter.
The KARE clinical research study, led by Prof. Celia Morgan of the University of Exeter, was a Phase II a/b, four-armed, placebo-controlled trial assessing ketamine combined with the KARE psychotherapy in the treatment for alcohol use disorder (AUD). The study started in 2016, finished in 2020 and included 96 participants, funded by the Medical Research Council. The primary endpoints of the Phase II trial were percentage days abstinent and relapse at 6 months, with secondary endpoints including depressive symptoms, craving, and quality of life.
The combined therapy arm, compared to other arms, demonstrated a clear capacity to improve the lives of people struggling with alcohol problems by reducing drinking over a six-month period.
Awakn also today announced that Prof. Celia Morgan will support Awakn’s activity in bringing the KARE research forward from Phase II to Phase III (subject to regulatory approval) and introducing evidence-based Ketamine-Assisted Psychotherapy for AUD into Awakn’s clinics as they open throughout the UK and EU.
Prof. Celia Morgan stated “It is a great milestone in Ketamine-Assisted Psychotherapy to take this novel evidence-based treatment forward both into the clinic and to a fully definitive Phase III trial. The Phase III study of Ketamine-Assisted Psychological therapy would be a world first in any patient group, and the first Phase III trial of ketamine in Alcohol Use Disorder.”
Dr. Ben Sessa, Awakn Chief Medical Officer, stated “Psychotherapy forms the bedrock of the way we use ketamine at Awakn, Celia Morgan’s cutting-edge research is the world’s first evidence-based approach combining ketamine with psychotherapy to treat Alcohol Use Disorder. In this post-COVID era there is no better time to be bringing this effective treatment approach to our patients struggling with alcohol use disorder.”
About Awakn Life Sciences Inc.
Awakn Life Sciences is a clinical-biotech company researching, developing, and delivering psychedelic medicine to treat Addiction and other mental health conditions. Awakn is integrating psychedelic medicine into mainstream healthcare through Research, Clinics, and Ecosystems.
About the University of Exeter
The University of Exeter is a Russell Group university that combines world-class research with very high levels of student satisfaction. Exeter has over 21,000 students and is in the top one per cent of universities worldwide. Exeter is also ranked 10th in the Guardian University Guide 2020 and 14th in The Times and The Sunday Times Good University Guide 2018. In the 2014 Research Excellence Framework (REF), the University ranked 16th nationally, with 98% of its research rated as being of international quality, while in 2017, Exeter was awarded a Gold rating in the Teaching Excellence Framework (TEF) assessment. Exeter was named The Times and The Sunday Times Sports University of the Year 2015-16, in recognition of excellence in performance, education and research. Exeter was The Sunday Times University of the Year 2012-13.
The University launched its flagship Global Systems Institute in 2018, a world-class, interdisciplinary community of researchers, students, citizens and partners that will solve global challenges through transformative research and education. This follows recent investments of more than £350 million worth of new facilities across its campuses in recent years; including the Living Systems Institute in 2016 in Exeter, and the Environment and Sustainability Institute on the Penryn Campus in Cornwall, together with new student services hubs, and new facilities for Biosciences, the Business School and Renewable Energy.
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