Awakn Life Sciences Corp. AWKNF reported it secured funding from Innovate UK to identify the quickest and most cost-effective route to market in both the U.K. and the U.S. for its lead program — Project Kestrel, proprietary ketamine-assisted therapy for treating Alcohol Use Disorder (AUD).
Awakn is a key player in the psychedelic-therapeutics space. The company researches, develops and commercializes psychedelic drugs for the treatment of addiction. Other companies in the sector include Mind Medicine Inc. MNMD and Atai Life Sciences N.V. ATAI.
Awakn recently completed its Phase II b study, stating that it showed promising potential for ketamine-assisted therapy to revolutionize the treatment of AUD. The company also has a patent pending that will make it the first with exclusive rights to use ketamine or ketamine -assisted therapy for the treatment of behavioral addictions. This development might be significant, as there are currently no effective pharmacological treatments available for behavioral addictions.
The ‘route to market’ strategy will be delivered in collaboration with Veristat, a global clinical research organization (CRO) that specializes in accelerating client therapies through the clinical development process into regulatory approval and commercialization.
Veristat says it enables sponsors to solve unique and complex challenges associated with accelerating therapies from clinical development to regulatory approval. Veristat supported marketing applications for 12% of all U.S. Food and Drug Administration (FDA) novel drug approvals in 2021.
Awakn Chief Scientific Officer Shaun McNulty said, “Our Phase II a/b ‘KARE’ study, led by professor Celia Morgan, showed that ketamine-assisted therapy has the potential to revolutionize 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 U.K. and the U.S. 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 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 caliber 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 also reported that it is planning and intends to initiate a Phase III trial in the U.K. in 2022 as a prelude to initiating a further Phase III trial in the U.S. 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 from the National Institute for Health and Care Research (NIHR) in the U.K. to cover two-thirds of a CA$3.75 million ($2.9 million) planned U.K. Phase III trial, an announcement on this is expected soon
The outputs from Project Kestrel are meant to 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 Awakn is developing therapies for.
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