Awakn Life Sciences Corp. AWKNF, a revenue-generating biotech company researching, developing and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced that its upcoming Phase 3 clinical trial assessing ketamine-assisted therapy for treating severe AUD will be delivered across seven National Health Service (NHS) sites in the UK.
The trial will receive funding for 66% of total costs (forecasted at almost $2.8 million) by another UK government agency, the National Institute for Health and Care Research (NIHR.) Awakn would invest slightly less than $1 million.
“For this Phase 3 to have the support and funding from the NIHR and for it to be delivered in the NHS is a great endorsement of this treatment’s potential and a sign of how badly a new more effective treatment is needed to help the millions of people suffering from alcohol addiction in the UK,” Awakn’s CEO Anthony Tennyson said.
The trial will be conducted by the University of Exeter (UoE) with professor of psychopharmacology and Awakn’s head of ketamine-assisted therapy, Dr. Celia Morgan.
280 people with severe AUD will be recruited and participants will be randomly divided into two groups. One will be given ketamine in conjunction with Awakn’s proprietary psychological therapy developed for the Phase 2 trial and the other a low dose of ketamine and a seven-session education package about alcohol’s harmful effects.
This Phase 3 trial, expected to be the largest ketamine-assisted therapy clinical trial to date and the only Phase 3 psychedelic clinical trial ever to receive government funding, intends to be a pivotal trial, following Phase 2 a/b trial’s strongly positive results: participants experienced an average 86% abstinence at six-months post treatment versus 2% pre-trial.
The new study will then focus on establishing further definitive evidence and move towards licensing of the treatment for this specific indication. Awakn, UoE and the NHS will work with the UK Dept. of Health and Social Care as well as other key stakeholders throughout the trial to facilitate the uptake within the NHS post trial if results show positive.
“More than two million UK adults have serious alcohol problems, yet only one in five of those get treatment. Unfortunately, three out of four people who quit alcohol will be back drinking heavily after a year. Alcohol-related harm is estimated to cost the NHS around $4.3 (£3.5 billion) each year, and wider UK society around £40 billion. Alcohol problems affect not only the individual but families, friends and communities, and related deaths have increased still further since the pandemic. We urgently need new treatments. If this trial definitively establishes that ketamine and therapy works, we hope we can begin to see it used in NHS settings,” concluded Dr. Morgan.
Photo courtesy of Andrea Piacquadio on Pexels and DanielTahar on Wikimedia Commons.
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