Agreement Provides 12-Month Exclusive Period to Agree in-Licensing Deal for Proprietary Formulation of Ketamine
Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced today it has signed a twelve month option agreement with a leading drug development, manufacturing, and delivery systems company to in-license a proprietary formulation and route of administration for ketamine. The formulation and route of administration will be optimized for commercialization and has the potential to deepen the intellectual property (IP) moat for Awakn's lead clinical development program Project Kestrel, which targets AUD.
AUD is a chronic disease with a poor current standard of care. AUD affects 400 million1 people globally with an approximate 25% abstinence rate within 12 months of treatment2. Despite this poor efficacy, the AUD treatment market in Awakn's two core territories of the U.S. & U.K. is significant. The U.S. AUD treatment market is valued at CA$45 billion3, while the U.K. state spends more than CA$5.5 billion a year4 on AUD related illness.
Awakn's Phase II b clinical trial, which was part of Project Kestrel, delivered 86% abstinence at 6 months post treatment compared to the standard 25% abstinence rate. Awakn is now progressing this program into Phase III in the U.K. Awakn also signed a Memorandum of Understanding with the U.K. public healthcare system, the NHS, in December 2021 to establish a partnership to assess NHS organizational readiness for ketamine-assisted therapy and to collaborate on how to accelerate the on-label use of ketamine-assisted therapy to treat AUD within the NHS' existing infrastructure.
The proprietary formulation of ketamine and optimized route of administration in scope for this agreement has the potential to provide the best possible patient experience and outcomes in addition to deepening Awakn's IP moat. Awakn is planning for the new formulation to be evaluated in its Phase III clinical trial.
Anthony Tennyson, Awakn's CEO commented, "We are very happy to sign this agreement which is a key milestone in our strategy to bring our proprietary ketamine-assisted therapy for the treatment of AUD to market and to be able to help such a large cohort of people who are in such desperate need of an effective treatment and unfortunately do not currently have one."
About Awakn Life Sciences Corp.
Awakn Life Sciences Corp. is a revenue-generating biotechnology company researching, developing, and commercialising therapeutics to treat substance and behavioral addictions. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 400m people globally for which the current standard of care is inadequate. Our goal is to provide effective therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels.
About Project Kestrel
Project Kestrel is the lead clinical development program of Awakn Life Sciences. Project Kestrel is supported by Awakn's Phase II a/b 'KARE' clinical trial which examined ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD). The trial resulted in patients experiencing on average 86% abstinence at 6 months post treatment versus 2% before the trial which means that study participants went from being sober on average 7 days a year to being sober on average 314 days a year. Awakn is planning to initiate a Phase III trial in the UK in 2022 and plans to seek regulatory approval in the UK and the US in due course.
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Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.
This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company's and Awakn's securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
Anthony Tennyson, CEO, Awakn Life Sciences
America and Canada: KCSA Strategic Communications
Rest of World:
Gordo Whittaker, CMO, Awakn Life Sciences
1: Global Burden of Alcohol Use Disorders and Alcohol Liver Disease. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6966598
2: "Treatment rates for alcohol use disorders: a systematic review and meta-analysis" by Tesfa Mekonen
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