Awakn Life Sciences selects PRA Health Sciences as CRO for Phase II study of MDMA as a treatment for alcohol use disorder

Awakn Life Sciences selects PRA Health Sciences as CRO for Phase II study of MDMA as a treatment for alcohol use disorder

Preparation for Phase II Study Positions Awakn Life Sciences at the Forefront of Psychedelic Research for Addiction Treatment

 Dr. Ben Sessa, Chief Medical Officer, will be principal investigator for the Phase II trial

London, UK – January 18, 2021 - Awakn Life Sciences, a biotechnology company focused on the research, development, and delivery of psychedelic medicines for the treatment of addiction and CNS disorders, announced today the selection of contract research organization (‘CRO’), PRA Health Sciences, to conduct a Phase IIb trial studying the effectiveness of MDMA assisted psychotherapy as a treatment for patients with Non-Physically Dependent (‘Harmful Use’) Alcohol Use Disorder (“AUD”).

Awakn’s Phase IIb study will take place in the UK and will be a double-blind, placebo-controlled clinical trial designed to investigate the efficacy and safety of MDMA as a pharmacological treatment for Alcohol Use Disorder.

 Alcohol use disorder is the most prevalent substance use disorder, with alcohol use as one of the top five causes of disease and disability in almost all countries throughout Europe. In the UK, alcohol and related diseases are the leading cause of death in men aged between 16 and 54 years, accounting for over 20% of the total UK adult population.

 While there are current treatment methods available, which are effective for some of the population, relapse rates are high and there is a large unmet need for effective treatments.

 Principal investigator for the Phase II trial will be Dr. Ben Sessa, Chief Medical Officer of Awakn, who previously led the world’s only MDMA and AUD study. Dr Sessa commented, “The prevalence of AUD – and the poor outcomes from contemporary psychiatry at treating this massive public health problem - have always been worrying. But in this post-Covid world the situation has significantly worsened. With drinking habits increasing everywhere during lock-down, we are now facing an epidemic of increasing mental disorders and addictions to all substances, of which AUD is by far the most concerning. Now is the time for innovative, safe and effective approaches to tackle AUD. MDMA-assisted psychotherapy, as evidenced from our world’s-first pilot study on the subject, is well-placed to help patients with AUD tackle rigidly held narratives surrounding their history of trauma that maintains their harmful drinking. I am pleased that we at Awakn are spear-heading the global initiative to develop new efficacious strategies for tackling this devasting condition. Sadly, we were better at treating alcoholism in Victorian times than we are today. This situation has to change. Our worthy patients deserve the very best that cutting-edge psychopharmacology research can offer. I strongly believe – driven by emerging evidence – that MDMA-assisted psychotherapy will play a central part in our future of the management of AUD.”

The study team is chaired by Prof. David Nutt, Edmund J. Safra Professor of Neuropsychopharmacology in the Division of Brain Science, Dept of Medicine, Imperial College London and Chair of Awakn’s Scientific Advisory Board. Prof. Nutt stated, “I am pleased with what is an exciting opportunity to conduct regulatory-level trials that I hope will turn our discovery of MDMA as a treatment for alcoholism into a clinical therapy.”

 "We are incredibly pleased with this announcement and our rapid progress to date. Partnering with a CRO is a key step on our journey to be the leader in using psychedelic medicines to treat addiction and other mental health disorder indications. The data from this trial will be used for us to progress into our phase III study,” said Anthony Tennyson, CEO of Awakn.

About Awakn Life Sciences

Awakn Life Sciences is a biotechnology company focused on the research, development, and delivery of psychedelic medicines for the treatment of addiction and CNS disorders. Awakn is creating a paradigm shift in psychiatry by integrating psychedelic medicine into mainstream mental healthcare with a strategic focus on the treatment of Addiction, Anxiety, Depression, and PTSD across three business lines of Research, Clinics, and Platforms. For more information, please visit www.awaknlifesciences.com.

 About PRA Heath Sciences

PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, Africa, Australia and the Middle East and more than 17,500 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.com.

Company Contact:

Anthony Tennyson | CEO

anthony@awaknlifesciences.com

Dr. Ben Sessa | CMO

ben@awaknlifesciences.com