Awakn intends to run a Phase III trial for ‘Ketamine-Assisted Psychotherapy for Alcohol Use Disorder’

Awakn announced today 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 form 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, who recently announced results of the world’s first ‘MDMA in Alcohol Use Disorder’ clinical trial 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."

Awakn announces today the publication of results from its CMO Dr. Ben Sessa's Bristol Imperial MDMA in Alcoholism (BIMA) trial, an open-label safety, tolerability and proof-of-concept study investigating the potential role for MDMA-Assisted Psychotherapy in treating patients with alcohol use disorder (AUD).

Results published today in the Journal of Psychopharmacology, show that MDMA-Assisted Psychotherapy (3,4-methylenedioxymethamphetamine) was well tolerated by all participants. No unexpected adverse events were observed, and psychosocial functioning improved across the cohort.

Over an eight-week course of therapy, participants received two sessions with MDMA (187.5 mg each session). Psychological support was provided before, during and after each session. Significantly, at nine months post detox, the average units of alcohol consumption by participants was 18.7 units per week compared to 130.6 units per week before the detox. This compares favourably to a previous observational study (the 'Outcomes' study) by the same team with a similar population of people with AUD.

Dr Ben Sessa, Awakn's Chief Medical Officer, commented, "This is the first clinical study into the potential effectiveness of MDMA-Assisted Psychotherapy as a treatment for Alcohol Use Disorder. It provides preliminary support for the safety and tolerability of MDMA post-detox. Awakn is now designing further trials to examine better the therapeutic potential of MDMA. I am very grateful for the inspirational work of my research colleagues, Dr. Laurie Higbed, Prof. David Nutt, and Steven O'Brien."

Alcohol use disorder is the most prevalent substance use disorder, with alcohol use one of the top five causes of disease and disability in almost all countries throughout Europe [i]. 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 [ii]. These figures are also predicted to rise as a result of the COVID pandemic. While there are current treatment methods available, which are effective for some segments of the population, relapse rates are high.

The study team was chaired by Awakn's Chair of the Scientific Advisory Board, Prof. David Nutt, Dept of Medicine, Imperial College London. He added, "This clinical study supports the practical experience of many thought leaders in psychiatry that psychedelic-assisted treatments, including MDMA for mental health disorders, have the potential to deliver significantly better outcomes for many patient groups."

Awakn is bringing this research forward into a Phase IIb study in the United Kingdom and will be a double-blind, placebo-controlled clinical trial designed to investigate further, the safety and efficacy of MDMA-assisted psychotherapy for Alcohol Use Disorder.

Awakn's CEO Anthony Tennyson said, "Today's publication of our CMO's BIMA study is an important milestone. This was the world's first clinical research study exploring MDMA-Assisted Psychotherapy as a treatment for any addiction, and the results are promising. We look forward to advancing this research into Phase IIb in 2021 with our goal being MDMA-Assisted Psychotherapy approved as a treatment for AUD."

Today Awakn announces the appointment of James Collins as Chief Operating Officer, effective January 2021.

Collins joins from Accenture Strategy where he was a Managing Director (London) for several years, responsible for client relationship development, sales, delivery, and European & Global practise management. He is an industry thought leader with several publications on digital innovation and the transformation of industries, including major studies in collaboration with the World Economic Forum.

He will be responsible for executing corporate strategy and refining the operating model of the business. Whilst at Accenture, James was a champion for Inclusion, Diversity & Mental Health driving awareness and structural change to address inequality in the workplace. James holds a BSc and MPhil in Psychology from University College London (UCL).

“This is the perfect time to join Awakn as it begins to realise its potential to reshape the landscape in addiction and mental health treatment,” said Collins.

“The application of psychedelic medicine in the treatment of addictions and other mental health issues has the potential to transform the lives of millions of people struggling with mental health disorders, and addictions.”

Anthony Tennyson, Awakn CEO, said, “We are delighted to welcome James to Awakn. He is passionate about changing the paradigm of how addiction and mental health conditions are treated in the UK, EU, and US. This passion in addition to his experience and expertise will help us as we build and scale our business.”

Awakn announces today the appointment of Dr. Shaun McNulty, formerly at GlaxoSmithKline (GSK), as Chief Science Officer and Prof. Celia Morgan, from Exeter University, as Head of Ketamine-Assisted Psychotherapy for the company’s Alcohol Use Disorder (AUD) Practice; both effective January 2021.

Dr. McNulty joins as an experienced biotechnology executive with over 20 years’ experience in drug development having previously held positions at Pfizer, GSK, Syntaxin, ImmBio, Biosceptre and Inflection Biosciences. He will be responsible at leadership level for executing Awakn’s research programmes and clinical trials.

“I am delighted to join Awakn at this exciting time in its expansion. The company has established a world class team to develop psychedelics for the treatment of patients. This highly innovative proven approach has the potential to address poorly met medical needs to improve the lives of millions of patients and their families,” said Dr. McNulty. 

Prof. Morgan will be responsible for leading Awakn’s newly established Ketamine-Assisted Psychotherapy for AUD Practice. Prof. Morgan is a Professor of Psychopharmacology at the University of Exeter in the United Kingdom, where she led the Ketamine for Reduction of Alcoholic Relapse (KARE) clinical trial, one of the world’s leading trials assessing Ketamine as a pharmacological treatment for Alcohol Use Disorder.

“I’m extremely excited to work with Awakn to take our Ketamine-Assisted therapy forward. We have shown potential to help the huge numbers of people struggling with alcohol problems in our first Medical Research Council funded phase II trial and now it is time to take it forward to the next stage,” said Prof. Morgan.

Anthony Tennyson, Awakn CEO, said, “We are delighted to welcome professionals of the calibre of Shaun and Celia to Awakn. Their experience and expertise will help us accelerate as we build and scale our business across our three divisions of Research, Clinics, and Platforms”.

PRA Health Sciences selected for the study which will position Awakn at the Forefront of Psychedelic Research for Addiction Treatment

Awakn announces 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."

1169082 B.C. Ltd. is pleased to announce that it has entered into a non-binding letter of intent with Awakn Life Sciences Inc., whereby 1169082 B.C. Ltd. and Awakn have agreed to negotiate exclusively in respect of a transaction to combine their respective businesses. The Proposed Transaction will be structured following the review and consideration by the parties of applicable tax, securities, corporate law, and other relevant considerations and shall be subject to standard closing conditions, including receipt of any required regulatory or shareholder approvals.

In conjunction with the Proposed Transaction, 1169082 B.C. Ltd. and Awakn intend to jointly apply to the NEO Exchange for the listing of the common shares of the resulting issuer. Such a listing would be subject to the approval of the NEO Exchange and the satisfaction by the resulting issuer of the NEO Exchange's listing conditions.

The appointment continues to strengthen Awakn's industry leading Scientific Advisory Board

Awakn is pleased to announce the appointment of Professor Celia Morgan to its Scientific Advisory Board (SAB).

Celia Morgan is a Professor of Psychopharmacology at the University of Exeter in the United Kingdom. She is one Europe's leading Ketamine researchers & investigators and the academic lead for the Exeter Translational Addiction Partnership. Prof. Morgan's research focuses on examining both the benefits and side effects of recreational drugs on cognition, mental health and neurobiology and includes leading the ground-breaking Ketamine for reduction of Alcoholic Relapse clinical trial.

Awakn's SAB provides strategic scientific counsel as the company implements its vision and strategy across three business lines of clinical research, therapeutic clinics and practitioner training.

Prof. Morgan stated, "I'm very excited to join such a distinguished team with a unique breadth of expertise across the spectrum of psychedelic assisted therapies. Through this synergy, and their vision, Awakn have the potential to rapidly transform the field, and to oversee the realisation of these compounds as the medicines they richly deserve to be. It's a great privilege to be a part of this."

Dr. Ben Sessa, Awakn CMO, commented, "Celia Morgan has been a long-time friend and colleague whom I respect and admire; from her earliest days when she conducted highly unique and creative research observing real-life ketamine users in their homes in London, to her latest project; spearheading the UK's largest clinical trial with ketamine psychotherapy for the treatment of alcoholism. Her interests align perfectly with those of us at Awakn; using psychedelics not purely as pharmacological agents or for managing wellness issues in non-clinical populations; but rather using these important drugs in combination with psychotherapy to develop the best therapies for our worthy patients. She will be a valuable addition to our team, and we are grateful to have her aboard. Welcome Celia!"

Anthony Tennyson, Awakn CEO, stated, "I am also very pleased that we are adding an advisor with such a deep level of relevant psychedelic experience and pedigree to our Scientific Advisory Board. Celia is working at the leading edge of ketamine research and I am looking forward to working with her and seeking her guidance and counsel on our continued journey."

Appointment of two leaders from the Multidisciplinary Association of Psychedelic Studies further strengthens AWAKN's industry leading scientific advisory team

Awakn is pleased to announce the appointment of Dr. Michael Mithoefer and Ann Mithoefer to its Scientific Advisory Board (SAB).

Dr. Mithoefer, Senior Medical Director for Medical Affairs, Training and Supervision at MAPS Public Benefit Corporation (MPBC), has, has worked with MAPS since 2000, while Ann Mithoefer, a registered Nurse and Lead MDMA-Assisted Psychotherapy PTSD Investigator at MAPS, has worked with MAPS since 2004. Together Dr. Michael Mithoefer and Ann Mithoefer are two of the world's leading MDMA-assisted psychotherapy investigators and trainers. Michael and Ann have completed: two of the six MAPS-sponsored Phase II clinical trials testing MDMA-assisted psychotherapy for PTSD; as well as a pilot study treating couples with MDMA-assisted psychotherapy combined with Cognitive Behavioral Conjoint Therapy; and a study providing MDMA-assisted sessions for therapists who have completed the MAPS Therapist Training.

Awakn's SAB provides strategic scientific counsel as the company implements its vision and strategy across three business lines of clinical research, therapeutic clinics and practitioner training.

Dr. Michael Mithoefer stated: "Annie and I are delighted to join the Awakn SAB for a combination of reasons. Their mission, in response to the urgent need for more effective treatments, is to develop and support further clinical research and training programs for psychedelic therapists, with the aim of providing access to affordable treatments using psychedelic-assisted therapy as these compounds become legal for clinical use. This is very much in alignment with the goals we've all been working toward at MAPS and Maps Public Benefit Corporation for many years. The other draw for us is that we've known David Nutt and Ben Sessa for a long time, and we have confidence in the expertise and integrity they bring to the project. And they're inspiring and fun to work with."

Dr. Ben Sessa, Awakn Chief Medical Officer, commented on the appointments: "For me, my first introduction to modern psychedelic research started in the early 2000's when I discovered the work of the Multidisciplinary Association for Psychedelic Studies (MAPS) and the ongoing MDMA-for-PTSD study being run by Michael and Annie Mithoefer. I subsequently met Michael in 2007 at a conference in Vienna, where we discussed bringing clinical MDMA assisted psychotherapy to the UK. It took another ten years to achieve that goal."

"During that time, I got to know Annie and Michael well; having them stay at my house in Somerset and I stayed with them in South Carolina, receiving formal MDMA therapy, delivered by the Mithoefers, in a clinical setting as part of my training to become an MDMA psychotherapist. So I am pleased to know that Annie and Michael have joined AWAKN's SAB. Annie, as the one of world's most experienced MDMA therapy nurses, brings multidisciplinary approach to the AWAKN board; especially in our design of clinical protocols, which put our patients' care at the centre of their bespoke clinical care plans. Michael, undoubtedly the most experienced MDMA doctor anywhere, will provide invaluable scientific advice; not only to AWAKN's MDMA protocols, but to all psychedelic projects going forward. And, given their roles as MAPS trainers, both Annie and Michael will of course be essential in the development of our therapist training courses; helping to achieve the aim of training hundreds of new psychedelic therapists in the next few years. Welcome on board, the pair of you!"

Finally, Prof. David Nutt, Chair of AWAKN's Scientific Advisory Board, stated: "I am delighted to have the great pioneers of MDMA treatment of PTSD join our research team. They will provide outstanding clinical insights."

Professor of Psychiatry and Behavioural Sciences at Johns Hopkins Appointed as Member of Scientific Advisory Board

Awkan is pleased to announce the appointment of Dr. Matthew Johnson, Ph.D, to its Scientific Advisory Board (SAB).

Dr. Johnson is one of the world's most published scientists on the human effects of psychedelics. He has conducted seminal research in the behavioral economics of drug use, addiction, and risk behavior through his role of Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University.

Dr. Johnson published psychedelic safety guidelines in 2008, helping to resurrect psychedelic research; he developed and published the first research on psychedelic treatment of tobacco addiction in 2014; published the largest study of psilocybin in treating cancer distress in 2016; and his 2018 psilocybin abuse liability review recommended the placement in Schedule-IV upon potential medical approval. He also published in 2017 the first data indicating that MDMA pill testing services may reduce harm, specifically by reducing drug consumption of unknown or undesired adulterants.

Awakn's SAB provides strategic scientific counsel as the company implements its vision and strategy across three business lines of clinical research, therapeutic clinics and practitioner training.

Dr. Ben Sessa, Awakn Chief Medical Officer, stated: "Dr. Matthew W. Johnson, Ph.D., is Professor of Psychiatry and Behavioural Sciences at Johns Hopkins University, Baltimore, USA. His career and CV in the field of psychedelic research is as impressive as his personal connections and networks within the field. Since the early 2000's, working alongside Professor Roland Griffiths, the Johns Hopkins team have set the standard for contemporary psilocybin research. And Matt has since gone on to carve his own path through this ever-emerging space. His special area of interest is addictions. He carried out the world's first psilocybin therapy study exploring a treatment for nicotine addiction and is now exploring psilocybin as a treatment for opiate dependence. But Matt's depth of knowledge goes far beyond that of simply the neurobiology of psychedelics. Matt's personality is that of an open-minded, compassionate scientist, which informs his extensive work around the social, cultural and psychological aspects of drug misuse; making him equally comfortable and informed carrying out studies amongst recreational users as he is with clinical patients."

"It is exactly this kind of multidisciplinary, world-leading and pioneering approach to all aspects of psychedelic research and practice that makes him perfectly suited for the Awakn scientific advisory board. Under Matt's guidance, Awakn can push in even further innovative directions in our quest for essential future applications of psychedelics for much-needed major public concerns. We warmly welcome him to Awakn. Above all else, beyond the academic heroism, he is a great pleasure to be around."

Anthony Tennyson, Awakn CEO, stated, "Dr. Johnson is at the forefront of international research and thought leadership in the psychedelic field. His experience and knowledge will be invaluable to Awakn on our journey to becoming the leader in European psychedelic assisted psychotherapy. I am extremely pleased that Dr. Matthew Johnson has agreed to join Professor David Nutt, Dr. Ben Sessa, Dr. Dawn DeCunha and Dr. Mike Hart on our scientific team."

Science-led Drugs Charity Invites AWAKN to Join Its Working Group on Psychedelics

Awakn announces today the new partnership to coincide with Drug Science's inaugural Psychedelics Working Group meeting that took place this week on 14th July 2020.

Founded in 2010 by Professor David Nutt, Drug Science works to provide evidence for widespread application of psychedelic drugs within public health models. Its aim is to break the barriers of 50 years of medical censorship by creating a rational and enlightened approach to psychedelic research and clinical treatment.

AWAKN's Chief Medical Officer, Psychedelic Psychiatrist Dr. Ben Sessa will be the representative for the company alongside patient representatives, policy makers, scientists and healthcare professionals. The group shall be designing campaigns that will ultimately lead to the rescheduling of all psychedelic drugs for research and medical purposes.

Dr. Ben Sessa said of the new partnership, "A systematic overhaul of the current scheduling of psychedelic compounds is required so these medicines can be used to heal, not harm. We must reverse the nonsensical censorship of psychedelics so that life changing medicines and medical pathways can be realised. Working with Drug Science will exponentially assist progress."

The invite to join Drug Science comes following the recent appointment of Drug Science founder, Professor David Nutt, as chairman of AWAKN's Scientific Advisory Board.