The UK’s national innovation agency – Innovate UK – has provided funding to Awakn Life Sciences to help bring its ketamine-assisted therapy to alcohol use disorder (AUD) patients.
The funding will help to identify the quickest and most cost-effective route to market in both the UK and the US for Awakn’s lead programme – proprietary ketamine-assisted therapy for treating AUD.
Current addiction care most often consists of counselling and rehabilitation programmes. In the UK, 132,124 adults entered into treatment for addiction from 2019 to 2020, according to Public Health England, with people who are in treatment for alcohol addiction making up the second largest group of all adults in treatment, at 28 per cent.
UK organisation, Alcohol Change, highlights that 82 per cent of dependant drinkers are not accessing treatment, and that alcohol misuse is the biggest risk factor for death and disability among 15 to 49-year-olds in the UK. It is also estimated that over 30 per cent of people who stop drinking relapse within the first year, highlighting the need for more effective treatments for alcohol addiction.
Awakn has formerly carried out the world’s first controlled study exploring the use of ketamine-assisted psychotherapy for the treatment of AUD – the ‘KARE’ clinical trial – which demonstrated 86 per cent abstinence for six months following treatment. This therapy has the potential to save lives, according to the study’s lead researcher, Professor Celia Morgan.
Innovate UK – which helps businesses to grow through the development and commercialisation of new products, processes, and services – will fund Awakn’s activities for this research that will be delivered in collaboration with Veristat, a global Clinical Research Organization (CRO) that specialises in accelerating client therapies through the clinical development process into regulatory approval and commercialisation.
Awakn’s CSO, Shaun McNulty commented: “Our Phase II a/b ‘KARE’ study, led by Professor Celia Morgan, showed that ketamine-assisted therapy has the potential to revolutionise the treatment of AUD.
“This funding enables Awakn, working closely with Veristat, to bring a much-needed effective treatment approach to the market as soon as possible.
“Delivering this innovative therapeutic approach as rapidly as possible to patients in the UK and the US is critical to address this major unmet medical need.”
Awakn CEO, Anthony Tennyson, added: “Securing these funds from Innovate UK is a major endorsement of our efforts and approach to developing new and effective treatments for addictions.
“Our lead programme has all the right components to make a lasting difference for the very significant number of people who are suffering from AUD.
“We are also delighted to be working with a partner of the calibre of Veristat and to have the ability to benefit from their significant expertise. The addiction treatment market opportunity is, unfortunately, large and growing, and Awakn is uniquely positioned to offer proven therapeutics supported by data to sufferers for whom the current standard of care is inadequate and relapse rates are unacceptably high.”
Awakn has now renamed its lead programme to Project Kestrel – which will aim to deliver marketing authorisation and regulatory approval for ketamine-assisted therapy to treat AUD in both the UK and the US.
The company has stated that Project Kestrel builds on the Phase II a/b ‘KARE’ clinical trial and efficacy data, and that it has now started planning and intends to initiate a Phase III trial in the UK in 2022 as a prelude to initiating a further Phase III trial in the US. Both are designed to provide the key data necessary to bring Project Kestrel to the market as soon as possible.
Awakn has also applied for a grant to the National Institute for Health and Care Research (NIHR) in the UK to cover two-thirds of the cost of the planned UK Phase III trial and a decision on this application is anticipated shortly.
The company has emphasised that outputs from Project Kestrel will benefit all of Awakn’s Research and Development project portfolio by defining a clear regulatory pathway for drug-assisted therapies to treat AUD and a broad range of other behavioural addictions.
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