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.

Kestrel Project

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. | Twitter | LinkedIn | Facebook

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.

About Veristat

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. Twitter LinkedIn Facebook

Notice Regarding Forward-Looking Information

This press release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the future performance of the Company. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is planned”, “budget”, “expected”, “estimates”, “continues “, “expects”, “plans”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, these words and expressions or declare that certain actions, events or results “may”, “could”, “will”, “should”, “could” or “will” be taken, occur or be carried out, including statements relating to the activities of the Company. All forward-looking statements, including those contained herein, are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in these statements are based on reasonable assumptions, these statements are not guarantees of future performance and actual results or developments may differ materially from those indicated in the statements. Certain factors could cause actual results to differ materially from those indicated in the forward-looking information. These include, but are not limited to: COVID-19; fluctuations in general macroeconomic conditions; the Company’s business plans and strategies; the Company’s ability to comply with all applicable governmental regulations in a highly regulated business; the risks inherent in investing in target companies or projects that have limited or no operating history and that are engaged in activities currently considered illegal in certain jurisdictions; changes in laws; limited operating history; dependence on management; additional funding requirements; competition; fluctuations in the securities markets; inconsistent public opinion and perception regarding the medical use of psychedelic drugs; expectations regarding the size of the drug addiction market; and regulatory or policy change. Readers are cautioned that the foregoing list of factors is not exhaustive of factors that could affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements contained in this press release speak only as of the date of this press release or as of the date or dates specified in such statements.

Investors are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those projected in the forward-looking information. For further information on the Company, investors are invited to consult the public documents filed by the Company on SEDAR at 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, except as required by law.

This press release does not constitute an offer to sell or a solicitation of an offer to buy securities in the United States. The securities of the Company and Awakn have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Law”) or any state securities law and may not be offered or sold in the United States or to US persons unless registered under United States securities law and applicable state securities laws. securities or an exemption from such registration.

Comments are closed.