AWAKN LIFE SCIENCES RECEIVES UK STATE FUNDING TO IDENTIFY THE OPTIMAL ROUTE TO MARKET IN THE UK AND USA FOR ITS LEADING CLINICAL DEVELOPMENT PROGRAM – KETAMINE-ASSISTED THERAPY FOR THE DISORDER OF ALCOHOL CONSUMPTION
Awakn provides an update on the progress of its Lead program from phase II b to phase III
TORONTO, CANADA, July 05, 2022 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954), a revenue-generating biotechnology company that researches, develops and commercializes therapies to treat addiction with a near-term focus on alcohol use disorder ( AUD), is delighted to announce that it has secured funding from Innovate UK to identify the fastest and most cost-effective route to market in the UK and US for Awakn’s lead program – a proprietary ketamine-assisted therapy for the treatment of AUD. Innovate UK is the UK’s national innovation agency that funded an initiative jointly led by CPI and ABHI.
Awakn’s activities will be conducted in collaboration with Veristat, a global clinical research organization (CRO) specializing in accelerating client therapies through the clinical development process to regulatory approval and commercialization. Veristat supported marketing applications for 12% of all US Food and Drug Administration (FDA) new drug approvals in 2021.
Awakn Chief Scientific Officer Shaun McNulty said: “Our phase II a/b ‘KARE’ study, led by Professor Celia Morgan, has shown that ketamine-assisted therapy has the potential to revolutionize the treatment of the AUD. This funding enables Awakn, in close collaboration with Veristat, to bring an effective and much-needed treatment approach to market as soon as possible. Delivering this innovative therapeutic approach as quickly as possible to patients in the UK and US is essential to addressing this major unmet medical need.
Anthony Tennyson Awakn CEO added: “Receiving this funding from Innovate UK is a major endorsement of our efforts and our approach to developing effective new addiction treatments. Our Lead program has all the right components to make a lasting difference for the huge number of people who suffer from AUD. We are also delighted to work with a partner of the caliber of Veristat and to benefit from their significant expertise. The addiction treatment market opportunity is, unfortunately, large and growing, and Awakn is uniquely positioned to offer proven, data-backed therapies to patients for whom the current standard of care is inadequate and relapse rates are unacceptably high.
Awakn also provides a business update on its lead program. Awakn has renamed its main program Project Kestrel. The Kestrel project will aim to deliver marketing authorization/regulatory approval for ketamine-assisted therapy to treat AUD in the UK and US with clear intellectual property (IP) surrounding the treatment. The Kestrel project builds on the success of Awakn 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 patients with AUD.
Awakn has begun planning and intends to initiate a phase III trial in the UK in 2022 as a prelude to launching another phase III trial in the US thereafter. Both are designed to provide the key data needed to bring the Kestrel project to market as soon as possible. Awakn has also applied for a grant from the National Institute for Health and Care Research (NIHR) in the UK to cover two-thirds of the cost of the planned phase III trial in the UK and a decision on this application is expected shortly. .
The results of the Kestrel project will benefit Awakn’s entire portfolio of research and development projects by defining a clear regulatory path for drug-assisted therapies to treat not only AUD, but also a wide range of diseases. other behavioral addictions for which Awakn is developing therapies.
About Awakn Life Sciences Corp.
Awakn Life Sciences Corp. is a revenue-generating biotechnology company that researches, develops and commercializes therapeutic products to treat substance and behavioral addictions. Awakn’s short-term focus is on alcohol use disorder (AUD), a condition affecting 400 million people worldwide for which the current standard of care is inadequate. Our goal is to provide effective treatments to drug addicts who desperately need them and our strategy is focused on commercializing our R&D pipeline across multiple channels.
About the Kestrel Project
The Kestrel project is Awakn Life Sciences’ primary clinical development program. The Kestrel Project is supported by Awakn’s Phase II a/b “KARE” clinical trial which investigated ketamine-assisted therapy for the treatment of alcohol use disorder (AUD). The trial resulted in an average sobriety of 86% of patients 6 months after treatment compared to 2% before the trial, meaning that study participants went from sobriety on average 7 days per year to average sobriety 314 days a year. Awakn plans to initiate a phase III trial in the UK in 2022 and expects to seek regulatory approval in the UK and US in due course.
Veristat, a science-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies from clinical development to regulatory approval. With over 27 years of experience planning and executing clinical trials, Veristat is equipped to support any development program. The company has prepared nearly 100 marketing applications for approval with global regulatory authorities over the past 10 years.
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