Awakn Life Sciences initiates study of new formulation of (S)-ketamine to assess dissociative effect

Study has potential to lead to in-licensing agreement and accelerated path to Phase II

Toronto, Ontario–(Newsfile Corp. – January 24, 2023) – Awakn Life Sciences Corp . (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (“Awakn”), a biotechnology company developing therapies for the treatment of addiction with a short-term focus on Alcohol Use Disorder (AUD), today announces that it have initiated an exploratory study to determine the dissociative effect of a proprietary and patent-pending formulation of (S)-ketamine and optimized route of administration to support timely commercialization. Route.

Today’s news builds on Awakn’s August 2022 announcement of a 12-month option agreement with a leading drug development, manufacturing and delivery systems company to in-license a proprietary formulation of (S)-ketamine with an optimized route of administration.

Trial participants will consist of binge drinkers who will be administered a dose of (S)-ketamine delivered via a proprietary oral thin-film formulation. The study will evaluate the dissociative effect obtained from the formulation and look at alcohol cravings from the participants. The study will also assess mechanistic factors, including electroencephalographic (EEG) markers of increased neuroplasticity.

If the results of this study are positive, it will potentially lead to a global license agreement for Phase I data of the patent-pending oral thin-film (S)-ketamine formulation. This could result in Awakn advancing to a larger Phase II b study and having global exclusivity rights to use the thin film formulation in the treatment of all addictions.

The mass adoption of intravenously delivered ketamine-assisted therapy may be limited due to the requirement for specific infrastructure and clinicians to administer it. This underlines the need for a new administration route.

Professor Celia Morgan, who is leading the current study and led Awakn’s recent successful phase II b trial, which was hailed as one of the most important moments in psychedelic drugs in 2022 by several media outlets, commented: “This study is really exciting for the future of ketamine-assisted therapy in the treatment of alcohol problems. If we find a signal that this new formulation can work in alcohol abuse, this could open up ketamine-assisted therapy to a much wider range of clinicians, practitioners and patients. It may also be useful in rolling out this therapy in other indications. Our previous evidence has shown that ketamine-assisted therapy works in alcohol abuse, but this is somewhat limited due to the need to give the ketamine intravenously. This may then herald the emergence of ​​a much more widespread new treatment for people struggling with alcohol problems not currently served by existing treatments.”

Anthony Tennyson, Awakn CEO added, “This is an exciting development for Awakn that we believe will strengthen our innovative pipeline of therapeutics and corresponding IP. Critically, it also has the potential to improve treatment options and experiences for so many people suffering of alcohol use disorders. , with so few effective options available to them, the need has never been greater.”

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a biotech company developing therapies to treat addiction. Awakn has a short-term focus on Alcohol Use Disorder (AUD), a condition that affects 285 million people globally and for which the current standard of care is inadequate. Our goal is to deliver breakthrough treatments to addicts in desperate need, and our strategy is focused on commercializing our R&D pipeline across multiple channels.

www.AwaknLifeSciences.com | Twitter | LinkedIn | Facebook | www.AwaknClinics.com

Notice Regarding Forward-Looking Information

This news 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 company’s future performance. 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”, “anticipated”, “budget”, “planned”, “estimates”, “continues”, “forecasts”, “projects” , “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of or the negatives of such words and phrases or indicates that certain actions, events or results “may”, “could”, ” would”, “should”, “may” or “will” be taken, occur or be achieved, including statements relating to the Company’s business. All forward-looking statements, including those contained herein, are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future results 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 company’s business plans and strategies; the company’s ability to comply with all applicable government regulations in a highly regulated business; the inherent risks of investing in target companies or projects that have limited or no operating history and are engaged in activities that are currently considered illegal in some jurisdictions; changes in laws; limited operating history; dependence on management; requirements for additional funding; competition; fluctuations in the securities markets; inconsistent public opinion and perception of the medical use of psychedelics; expectations for the size of the addiction market; and legislative or policy changes. 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(s) specified in such statements.

Investors are cautioned that such statements are not guarantees of future performance and actual results or developments may differ materially from those anticipated in the forward-looking information. For more information about 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.

Investor inquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
[email protected]

Media Inquiries:
Gordo Whittaker, CMO, Awakn Life Sciences
[email protected]

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/152229

Awakn Life Sciences initiates study of new formulation of (S)-ketamine to assess dissociative effect

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