A new MoU will explore a partnership to utilise MDMA-assisted psychotherapy for the treatment of Alcohol Use Disorder (AUD) in Europe.
A data licensing agreement with the Multidisciplinary Association for Psychedelic Studies (MAPS) will be explored by Awakn under the terms of the MoU.
The agreement will look at the prospect of MAPS supporting Awakn’s Phase IIb and planned Phase III studies for MDMA-assisted therapy for AUD in Europe – a condition that affects 40 million people on the continent.
Awakn CEO, Anthony Tennyson, commented: “MAPS’ role in driving and advancing the use of psychedelics in the clinical setting over the last 35 years is second to none.
“We believe that by licensing MAPS’ pre-clinical data and exploring options for future ethical commercialisation, we will improve the timeline and path to market for these life-changing treatments for AUD, providing hope for those for whom the status quo is not working.”
The two leading psychedelic research companies will also assess a partnership to secure marketing authorisation/regulatory approval for ethical commercialisation.
“MAPS has been working with Awakn scientists for decades in the effort to initiate trials into a range of clinical uses of MDMA-assisted therapy,” added Rick Doblin, founder and executive director of MAPS.
“We’re delighted to be entering into this MoU with AWAKN which holds great promise for people suffering from AUD.”
Awakn announced the publication of the successful results of the BIMA Phase IIa study investigating MDMA-assisted therapy for the treatment of AUD in February 2021. The findings demonstrated a 21 per cent relapse rate at nine months compared to a significant 75 per cent relapse rate in a separate observational group.
Additionally, in May 2021, MAPS announced that it achieved successful results in its first of two Phase III trials for MDMA-assisted therapy for the treatment of severe chronic PTSD.
The results demonstrated that 88 per cent of participants who received three MDMA-assisted therapy sessions – along with twelve 90-minute, non-drug preparation and integration therapy sessions – experienced a clinically meaningful reduction in symptoms.
This amounted to a total of 67 per cent of participants no longer qualifying for a PTSD diagnosis afterwards.
Awakn is making strides in progressing psychedelic therapy in the UK and Europe. It has established the first network of psychedelic clinics in the UK, signed an MOU with an NHS Trust and the University of Exeter to increase access to psychedelic therapy in the UK in November 2021, and is currently leading a groundbreaking study into the use of ketamine-assisted psychotherapy for a number of addictions.
These include gambling disorder, binge eating disorder, compulsive sexual behaviour and internet gaming disorder.
The company also recently announced results from its Phase IIa/b ‘Ketamine for the Reduction of Alcoholic Relapse’ (KARE) clinical trial – the world’s first controlled study to investigate ketamine-assisted therapy for the treatment of AUD. The study was published in the American Journal of Psychiatry and was conducted by the University of Exeter.
Awakn CMO Dr Ben Sessa, commented: “This is another milestone in the advancement of successfully treating Alcohol Use Disorder.
“Currently there are millions suffering with very few promising lasting treatments and be it with MDMA or Ketamine-Assisted Therapy, we are exploring every promising avenue to treat a disease that not only impacts the individual, but also families and communities.”
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