Awakn Life Sciences Corp., a biotechnology company researching, developing and commercialising therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), has secured funding from Innovate UK to identify the quickest and most cost-effective route to market in both the UK and the US for Awakn’s lead program - ketamine-assisted therapy for treating AUD.
Key highlights:
- Awakn Life Sciences has secured funding from Innovate UK to move its Alcohol Use Disorder (AUD) treatment program, known as Project Kestrel, from Phase II to Phase III.
- Project Kestrel involves ketamine-assisted therapy to treat AUD in both the UK and the US with clear Intellectual Property (IP) surrounding the treatment.
- Securing funds from Innovate UK hopes to encourage new approaches to developing new and effective treatments for behavioural addictions.
- 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.
Innovate UK is the UK’s national innovation agency which provided the funding in an initiative delivered jointly by CPI and ABHI.
Awakn’s activities will be delivered in collaboration with Veristat, a global Clinical Research Organisation (CRO) that specialises in accelerating client therapies through the clinical development process into regulatory approval and commercialisation. Veristat supported marketing applications for 12% of all US Food and Drug Administration (FDA) Novel Drug Approvals in 2021.
Awakn’s chief scientific officer, 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.”
Anthony Tennyson, Awakn’s CEO, 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 program 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."
Project Kestrel
Awakn is also providing a business update on its lead program. Awakn has renamed its lead program to Project Kestrel. The project will aim to deliver marketing authorisation/regulatory approval for ketamine-assisted therapy to treat AUD in both the UK and the US with clear Intellectual Property (IP) surrounding the treatment.
Project Kestrel builds on Awakn’s successful Phase II a/b ‘KARE’ clinical trial and efficacy data released in January 2022, which demonstrated safety and efficacy as a new treatment option for AUD patients.
Awakn has 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 thereafter. 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 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 not only AUD but also a broad range of other behavioral addictions which Awakn is developing therapies for.