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Development

Intellectual Property Approach

We are creating a highly commercialisable IP portfolio of therapeutics for treating addiction.

To do so we are conducting ongoing clinical research programmes on ketamine and MDMA-assisted therapies, as well as creating and trialling a pipeline of novel patentable drugs with improved properties for treating addiction.

Our Therapy and Drug Development Pipeline

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Therapeutics Development Strategy

NEAR TERM

Ketamine

Ketamine-Assisted Psychotherapy for substance and behavioral addictions

MEDIUM TERM

MDMA

MDMA-Assisted Psychotherapy for Alcohol Use Disorder

LONG TERM

New Chemical
Entities

Substance and behavioral
addictions

Ketamine

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Our clinical trials show that ketamine is highly effective for treating Alcohol Use Disorder. Ketamine is currently the only licenced psychedelic in the UK. With this treatment programme, we will become the first company in the world to deliver clinically-tested psychedelic-assisted treatment outside of a clinical trial.

Our KARE (Ketamine in the Reduction of Alcoholic Relapse) clinical trials – the only Phase II trials to fully test ketamine-assisted therapy for Alcohol Use Disorder in the world – showed a far less chance of relapsing compared to a placebo treatment and a big reduction in alcohol use compared to the best therapies available. This paper and its detailed findings will be published in the American Journal of Psychiatry this year. Anecdotally, many participants reported sudden profound changes (‘like taking off my alcoholic jacket and hanging it up forever’) and the ease of giving up after struggling for years.

The therapies and dosing regimens in these trials will now be delivered through our network of clinics.

Ketamine changes the brain circuitry associated with addiction, allowing the person to be more flexible and open to new learning. Our trained therapists can harness this flexibility to help our clients weaken negative thought patterns and relearn positive ones.

We have also secured ethics approval in the UK to study how our ketamine-assisted treatment could treat Gambling Disorder, a behavioural addiction that affects more than 2.5% of American adults, that's almost 10 million Americans and it has no licensed pharmacological treatments. We will continue to study optimal conditions for effectiveness, treatments for other addictions, and how the treatment works at a neurobiological level.

MDMA

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We are researching MDMA to treat Alcohol Use Disorder.

Awakn has conducted the world’s only Phase IIa study of MDMA for Alcohol Use Disorder, BIMA (Bristol Imperial MDMA in Alcoholism Study), which is progressing into Phase IIb. The trial proved safety and showed high efficacy in a small group with three quarters showing continued improvement nine months later, compared to just 21% in a control group receiving current standard addiction treatment. The study was published in the Journal of Psychopharmacology.

MDMA works differently to ketamine. Brain scans show that it supresses activity in the amygdala and hippocampus, the areas that encode emotions, learning and memory. It is believed that MDMA supresses chemicals released in response to negative stimuli (such as revisiting trauma) thereby allowing clients to engage these painful memories without being overwhelmed. It also creates temporary changes in brain functioning that support the learning of new behavioural responses.

This is thought to explain why we see such a powerful effect from MDMA-assisted therapy, where clients can confront and overcome traumatic events, which lie at the root of their addiction, and engage with therapy to quickly develop new healthy ways of processing these memories.

We expect MDMA to be approved for treating PTSD by 2023, and addiction by 2025.

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New Chemical Entities (NCE)

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We are undertaking pre-clinical drug discovery to generate new molecules with even better properties than those presented by ketamine and MDMA, to treat both substance and behavioural addictions.

These include novel MDMA-like compounds to offer more rapid onset of activity and a shorter half-life. This would allow shorter therapy sessions and treatment of more patients at reduced costs. We also hope to increase efficacy and the range of disorders we can treat.

We have filed patents for multiple compounds with considerably more in development, and plan to start human trials in 2024. Our aim is to have a licensable product that’s even better than MDMA and Ketamine.

Our NCE programme builds on significant proprietary research and know-how on next generation MDMA molecules acquired from Professor David Nutt’s Equasy Enterprises. From this research We have new insights into how MDMA works that no one else has, and due to these, we believe we can deliver new molecules to improve the quality of MDMA-assisted therapy.

We have partnered with Evotec to develop our new molecules, they are one of the world’s leading drug discovery contract research companies. We have identified compound series that provide the basis of future development activities and are a key milestone on the pathway to taking NCE’s into clinical trials.

The Competitive Landscape

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