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Project Kestrel

About Project Kestrel

Project Kestrel is the lead clinical development program of Awakn Life Sciences and is focused on repurposing ketamine in combination with therapy to treat alcohol and behavioral addictions.

Ketamine is an N-methyl-d-Asparate (NMDA) receptor agonist with well-established safety and efficacy as an analgesic and anaesthetic. At sub-anaesthetic doses ketamine produces alterations in consciousness, disrupts memory reconsolidation, and delivers downstream neuroplasticity, which when combined with therapy has been proven by Awakn to significantly reduce the probability of relapse for Alcohol Use Disorder. 

Project Kestrel builds on Awakn’s successful phase II a/b clinical trial for ketamine-assisted therapy for Severe AUD in which participants in the active arm achieved 86% abstinence at 6 months post treatment versus 2% pre-trial and 25% in current standard of care.

 Project Kestrel consistent of three work streams:  
• Repurposing racemic ketamine delivered IV in combination with therapy to treat Severe AUD.
• Repurposing (S)-ketamine delivered sub-lingually via Oral Thin Film (OTF) in combination with therapy to treat Mild & Moderate AUD.
• Repurposing (S)-ketamine delivered sub-lingually via OTF in combination with therapy to treat behavioral addictions.

Project Kestrel is supported by Awakn’s Phase II a/b ‘KARE’ clinical trial which examined ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD).  The trial resulted in patients experiencing on average 86% abstinence at 6 months post treatment versus 2% before the trial and 25% in the current standard of care.

Phase II a/b results

Ketamine-assisted therapy to treat Severe AUD

Repurposing ketamine in combination with therapy to treat Severe AUD

Goal: Repurpose and develop racemic ketamine as a marketed combined therapeutic to treat Severe AUD, initially in the UK.

Status: Phase II a/b successfully completed, 86% abstinence at 6 months post treatment achieved versus 2% pre-trial and 25% in current standard of care.

Next steps: Planned phase III trial to be initiated in H2 2023. N=280 two armed randomised control trail, delivered in the UK’s National Health Service (NHS) and has been granted 66% funding from the National Institute of Health and Research and the Medical Research Council. Total cost for the trial is CA$3.7 with Awakn funding CA$1.25m.

RACEMIC KETAMINE TO TREAT SEVERE AUD IN THE UK

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(S)-ketamine-assisted therapy (via OTF) to treat Mild and Moderate AUD

Awakn believes that a sub-lingual route of administration may be more suitable for treatment of Mild and Moderate AUD from the patient and practitioner perspective.

Goal: Repurpose and develop (S)-ketamine in a sub-lingual OTF as a marketed combined therapeutic to treat Mild and Moderate AUD.

Status: Awakn has signed 12-month exclusive agreement with a European pharmaceutical company to test the suitability of a proprietary and patent pending (S)-ketamine sub-lingual OTF with phase I completed. Awakn is running an investigative study to establish the dissociative effect of the OTF. 

Next steps: Potential global licensing agreement for phase I data of the patented oral thin film (S)-ketamine formulation and potential for Awakn advancing to a larger phase II study.

(S)-KETAMINE TO TREAT AUD

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(S)-ketamine-assisted therapy (via OTF) to treat behavioral addictions.

Behavioral addictions are defined as an intense desire to repeat actions that are pleasurable despite awareness that such an action may have negative consequences.

Most prevalent: Gambling Disorder (3% of adults), Binge Eating Disorder (2%), Compulsive Sexual Behavior Disorder (3–6%); Internet Gaming Disorder (3%).

Awakn believes (S)-ketamine delivered via OTF has the potential to be a successful treatment for behavioral addictions.

Goal: Repurpose and develop (S)-ketamine delivered via OTF as a marketed combined therapeutic to treat one or more behavioral addiction. 

Status:
Awakn also filed a Patent Cooperation Treaty (PCT) application for racemic ketamine, (S)-ketamine and (R)-ketamine as a treatment for behavioral addictions.

Next steps: Potential global licensing agreement for phase I data of patent pending (S)-ketamine OTF and potential for Awakn advancing to a larger phase II study.

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