AWAKN Shares Data from Phase 2 Study for Treating Alcohol Abuse with Ketamine

6 min readPublished On: January 12th, 2022By

TORONTO–Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat addiction, is delighted to announce ground-breaking positive data from their Phase II A/B trial. It was the first controlled trial in the world to investigate Ketamine-Assisted Therapy for the treatment of Alcohol Use Disorder (AUD), the results have been published in the American Journal of Psychiatry. The trial was conducted by University of Exeter and led by Professor Celia Morgan, Awakn’s Head of Ketamine-Assisted Therapy for Addiction and Professor of Psychopharmacology at UoE. Awakn acquired the intellectual property to the therapy under license for use in further research, its clinics in Europe, and its partnerships globally.

The positive Phase II trial outcome and Awakn’s newly formed partnership with the UK National Healthcare Service (NHS) and UoE, pave the way to progress this trial into Phase III. With the ultimate aim of securing regulatory approval for Ketamine-Assisted Therapy to treat AUD in the UK through the NHS and potentially in other territories.

The double-blind placebo-controlled trial included 96 patients with severe AUD, who were randomized to one of four groups: 1) three ketamine infusions (0.8 mg/kg IV over 40 minutes) plus proprietary manualized therapy (KARE); 2) three saline infusions plus KARE therapy; 3) three ketamine infusions plus alcohol education; and 4) three saline infusions plus alcohol education.

The primary outcomes of the trial were 1) Days abstinent in the 6 months after treatment, 2) Relapse at 6 month follow up. The findings showed that ketamine combined with KARE therapy, resulted in total abstinence in 162 of 180 days in the following 6-month period, achieving an increase in abstinence from around 2% prior to the trial to 86% post trial. The results for relapse at 6 months, showed that the Ketamine plus KARE group’s risk of relapse, was 2.7 times less then the placebo plus alcohol education group.

“Alcohol Use Disorder is a pervasive and persistent public health issue, affecting at least 390 million people globally. Treatment rates are low and relapse rates post treatment tend to be high. We urgently need new and more effective treatments,” said Prof. Morgan. “We found that controlled, low doses of ketamine combined with manualized psychological therapy can significantly increase post treatment abstinence rates. This is extremely encouraging, as we normally see three out of four people returning to heavy drinking within twelve months of treatment. The data we’ve collected from this study paves the way for a paradigm shift in how AUD is treated”

The secondary outcomes of the study identified further encouraging results including improved liver function across several different markers, a statistically significant decrease in depression after 3 months and an increase in the ability to experience pleasure.

In addition to the primary and secondary endpoints, Prof. Morgan identified further significant results in the reduction in heavy drinking days. At six months post trial, there was an average of 12 heavy drinking days in the Ketamine plus KARE group, this is a large reduction compared to other trials in this area and it is widely believed the real-world data is far higher than this. Within the KARE group there was also a significant decrease in the risk of mortality, 1 in 8 patients would have died within 12 months without treatment, that number decreased to 1 in 80 following the treatment.

In total, the trial demonstrated that three subanaesthetic infusions of ketamine support abstinence from alcohol and that abstinence may be further enhanced when ketamine treatment is combined with therapy. No serious adverse events took place during the trial.

Anthony Tennyson, Awakn’s Chief Executive added, “We are so pleased to see such encouraging results in an area of treatment that has been stagnant for so long, leaving so many people with little or sub-par options available to them. We will continue to support this research and future clinical trials as we push to bring a radical shift in the alcohol addiction treatment industry

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”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those 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 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: whether conditions to the listing on NEO will be satisfied; 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; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; 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.

(This information is primarily sourced from AWAKN.  Highly Capitalized has neither approved nor disapproved the contents of this news release. Read our Disclaimer here).

About the Author: News Team

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