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Project Kestrel

About Project Kestrel

Project Kestrel is the lead clinical development program of Awakn Life Sciences.  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 which means that study participants went from being sober on average 7 days a year to being sober on average 314 days a year.  Awakn is planning to initiate a Phase III trial in the UK in 2022 and plans to seek regulatory approval in the UK and the US in due course.

Phase II a/b (KARE) results:

THE RESEARCH QUESTION

Can Ketamine-Assisted Therapy increase abstinence rates in patients with Alcohol Use Disorder following detox?

Details of Phase II a/b (KARE)

  • Four armed Phase II a/b clinical trial for reducing relapse in Alcohol Use Disorder with the NMDA receptor antagonist Ketamine.
  • Funded by the UK State (Medical Research Council)
  • Conducted by University of Exeter
  • Led by Prof. Celia Morgan
  • Rights to KARE exclusively acquired by Awakn Life Sciences in February 2021
  • N=96
  • Published: December 2021 in the American Journal of Psychiatry
  • Full paper can be found here.
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Phase II a/b (KARE) Trial Design

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Phase II a/b (KARE) Treatment Protocol

The treatment protocol took place over 4 weeks and consisted of 7 therapy sessions of 1.5hrs long each, and three ketamine sessions.

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Results

Conclusions

Primary Outcomes


1. KARE therapy significantly increased abstinence over all other groups.
2. Odds ratio of relapse was reduced with the KARE therapy.

Secondary Outcomes


1. Ketamine groups showed increased liver function across several markers.
2. Ketamine groups saw reduced depression and anhedonia (inability to experience pleasure) at 3 months.

Exploratory Analysis 



Heavy drinking days were reduced in the KARE group compared to all other groups.

Safety


Ketamine was well tolerated and had a good safety profile, adverse events were predominantly mild and only  reported by 8/96 patients. No serious adverse events happened.

A Qualitative Study of Patients’ Experiences:
“This Is Something That Changed My Life”

In conjunction with the KARE study, a further study was conducted on the qualitative patient outcomes during the trial. This has also been published in Frontiers in Psychiatry, click here for the full paper.

Aim



The study aimed to examine participant experiences of ketamine infusions and how these relate to therapeutic mechanisms in a clinical trial setting.

Conclusion

Provided in a supportive and professional environment, ketamine treatment led to a significant change in their relationship with alcohol. Ketamine induced ego dissolution and dissociation were reported to be related to the transformational effects on relationship with alcohol.

PATIENT EXTRACTS

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