Biotech psychedelics company Awakn Life Sciences Corp. AWKNF has been granted funding for 66% of the costs from its phase 3 clinical trial on ketamine therapy for alcohol use disorder (AUD) by U.K's National Institute for Health and Care Research.
The trial is currently estimated to cost approximately CA$3.75 million ($2.91 million). The remaining CA$1.25 million ($970,000) are to be covered by Awakn.
The trial would constitute the largest ketamine-assisted therapy clinical study to date, and the only phase 3 psychedelic clinical trial to receive state funding. Awakn will partner with the University of Exeter and the U.K.'s National Health Service to conduct the research across seven sites in the UK within the NHS infrastructure.
Designed to include 280 patients who would receive a medical follow-up over the course of 6-12 months while also having the possibility to participate in peer support groups post-treatment, the current trial follows on from the groundbreaking January results of Awakn's phase 2 a/b trial, with alcohol use disorder participants experiencing on average 86% abstinence at six-months post treatment versus 2% pre-trial.
This phase 3 study is aimed at establishing further definitive evidence of the efficacy of ketamine-assisted therapy for the treatment of AUD, and to move towards obtaining its license. Its principal investigator will be professor Celia Morgan, Awakn's head of ketamine-assisted therapy and professor of psychopharmacology at the University of Exeter.
Facing the phase 3 trial funding, professor Morgan shared her optimistic view: "The trial represents a huge leap forward in the treatment of AUD. The financial commitment by the UK Government emphasizes the promise of this treatment and the scientific rigor behind the trial. This, coupled with running the trial in the NHS settings and working closely with regulators throughout, means that the probability of quick adoption is very high, should the results of this trial fulfill their early promise."
The announcement certainly seems to consolidate an already positive relationship Awakn established with the UK’s public healthcare system. In CEO Anthony Tennyson’s words: "We are pleased with today's news for several reasons. A government showing such strong support for this new type of treatment is a global first. Secondly, working with the NHS to deliver the treatment in their existing infrastructure is a huge statement of intent, but most importantly, for so many millions of people around the world suffering from alcohol addiction, a new treatment hope has just got one big 'step' closer."
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