January 15th, 2021
Awakn Life Sciences announced today the selection of contract research organization (‘CRO’), PRA Health Sciences (NASDAQ: PRAH), 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 United Kingdom and will be a double-blind, placebo-controlled clinical trial designed to investigate the safety and efficacy 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 segments of the population, relapse rates are high.
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 significant public health problem, have always been worrying. This situation has significantly worsened during Covid. With drinking habits increasing during lock-down, we are now facing a significant increase in 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 condition. Our patients deserve the best that cutting-edge psychopharmacology research can offer.”
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.”
Anthony Tennyson, CEO of Awakn also stated, “We are incredibly pleased with 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 to progress into our phase III study.”
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 mental health conditions. 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 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.
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