Awakn Life Sciences Completes World's First Ketamine Treatment Study for a Range of Behavioral Addictions

Awakn Life Sciences Completes World's First Ketamine Treatment Study for a Range of Behavioral Addictions

Promising Results Merit Larger Study Which Awakn is Initiating

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company, researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced today the completion of the world's first ketamine treatment study for behavioral addictions. The behavioral addictions included in the study were Gambling Disorder, Internet Gaming Disorder, Binge Eating Disorder and Compulsive Sexual Behavior.

The study was led by Prof. Celia Morgan, Awakn's Head of Ketamine-Assisted Therapy, Professor of Psychopharmacology at the University of Exeter, U.K., and an internationally respected expert in the therapeutic use of ketamine. The study investigated ketamine as a new treatment approach for these behavioral addictions by opening a window in which the brain can make new connections to change behavior.

The results from the study indicate the desired effects via potentially novel mechanisms and these results merit a larger study and further exploration, which Awakn is now initiating. The study also supports Awakn's Intellectual Property (IP) strategy and existing filed patent applications, positioning Awakn as a leading company in the behavioral-addiction therapeutic research and development industry. The company expects to update investors further on its IP strategy in the coming weeks.

Prof. Celia Morgan, Awakn's Head of Ketamine-Assisted Therapy, commented, "These promising early findings may suggest a new treatment solution in behavioral addictions, which are growing rapidly across the globe, and as yet, are a completely unmet treatment need. The team are excited to be starting these new significant studies which promise to bring considerable innovation to the field".

Awakn CEO, Anthony Tennyson commented, "This study is hugely encouraging and gave us all the data we could have hoped for. Critically, it also showed us that a larger study is merited, and we will now pursue this. For such a huge cohort of over a billion people to be suffering with no pharmacological treatment available to them, is unacceptable and we will strive to deliver therapies to patients who are in desperate need".

Gambling Disorder, Internet Gaming Disorder, and Binge Eating Order, all recognised in the DSM-5, affect up to 450 million[1], 235 million[2] and 100 million[3] people respectively, while Compulsive Sexual Behavior, which is included in the ICD-11, affects up to 350 million[4] people. Current standard of care for these conditions is poor.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company researching, developing, and commercializing combined therapeutics to treat addiction, with a focus on Alcohol Use Disorder. Awakn's team consists of renowned research experts, world leading chemists, scientists, psychiatrists, and psychologists. Addiction is one of the biggest unmet medical needs of our time, affecting over 20% of the global population and is an industry valued at over $100bn per annum. Awakn is working to disrupt this underperforming industry by advancing the next generation of drugs and therapies to be used in combination, through preclinical research and clinical stage trials.

www.awaknlifesciences.com | Twitter | LinkedIn | Facebook

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 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, 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.

Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awknlifesciences.com

Media Enquiries:
America and Canada: KCSA Strategic Communications
Anne Donohoe
Adonohoe@KCSA.com

Rest of World: ROAD Communications
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk


[1] Problem gambling worldwide: An update and systematic review of empirical research (2000-2015). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5370365

[2] The prevalence and correlates of binge eating disorder in the World Health Organization World Mental Health Surveys
https://pubmed.ncbi.nlm.nih.gov/23290497/

[3] Global prevalence of gaming disorder: A systematic review and meta-analysis. https://pubmed.ncbi.nlm.nih.gov/33028074/

[4] Epidemiology, Prevalence, and Natural History of Compulsive Sexual Behavior.
https://www.sciencedirect.com/science/article/abs/pii/S0193953X08000725

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/124630

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Seelos Therapeutics Announces Receipt of Minutes from its End of Phase II Meeting with the United States Food and Drug Administration Highlighting Modifications to the Primary and Secondary Endpoints of its Phase II Study of SLS-002

  • Company plans to continue its previously announced potential partnership discussions and expects to proceed to Phase III with SLS-002 in Adults with Major Depressive Disorder (MDD) at Imminent Risk of Suicide

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced the receipt of minutes from its End of Phase II Meeting with the FDA.

(PRNewsfoto/Seelos Therapeutics, Inc.)

In the meeting minutes, the FDA agreed that the primary endpoint in a Phase III trial could be the change from baseline in the Montgomery -Åsberg Depression Rating Scale (MADRS) total score at Day 16, rather than the 24-hour timepoint that was selected in the Phase II SLS-002-201 study. The key secondary endpoint could be the change from baseline at 24 hours on the suicidality scale. This agreement with the FDA gives Seelos further confidence for its Phase III development of SLS-002 as data in the Phase II study showed clinically significant treatment differences from placebo on both the Day 16 MADRS (p-value: 0.012) and the 24-hour Sheehan- Suicidality Tracking Scale (S-STS) (p-value: 0.008).

"We are very excited about the potential that SLS-002 has to address the unmet need of acute suicidality. We are working to design one robust Phase III trial that has the potential to demonstrate a statistically persuasive effect utilizing agreed FDA endpoints," said Raj Mehra, Ph.D., Chairman and Chief Executive Officer of Seelos.

"We want to thank the FDA for this collaborative discussion and look forward to future discussions on the modifications for the Phase III protocol that align with what SLS-002 previously demonstrated in the Phase II study," said Tim Whitaker , M.D., Chief Medical Officer of Seelos. "We also want to again thank all of the study participants and study sites who helped us gather important data in the Phase II study. This will help us refine the potential Phase III study. We also look forward to participating in the U.S. Department of Defense's (DOD) adaptive platform trial to evaluate treatments for post-traumatic stress disorder (PTSD)."

In 2022 there were 49,449 suicides in the U.S. and unfortunately, the medical community still lacks an FDA-approved therapeutic to treat the symptoms of suicidality. According to the Centers for Disease Control and Prevention (CDC) , in 2020, suicides and non-fatal self-harm cost the U.S. over $500 billion in medical and work-loss costs, value of statistical life, and quality of life costs. Suicidal patients who present suicidal ideation and behavior symptoms at an emergency department can be held in the emergency department for several days while awaiting an inpatient psychiatric bed.

If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the Suicide and Crisis Lifeline at 988 or 1-800-273-8255 (TALK).

About SLS-002

SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior in Major Depressive Disorder and in Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. Seelos looks to address an unmet need for a therapy to treat suicidality in the U.S. with SLS-002. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for refractory depression and suicidality.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in MDD, PTSD, amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

For more information, please visit our website: http://seelostherapeutics.com , the content of which is not incorporated herein by reference.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the Phase II study of SLS-002, statements regarding SLS-002's prospects and potential, statements regarding any potential market opportunity for SLS-002, statements regarding any planned meetings and discussions with the FDA, statements regarding any potential partnerships and discussions related thereto, statements regarding the Company's expectations to proceed to a Phase III trial for SLS-002 in adults with MDD and the protocol, trial design and endpoints for any such trial and the Company's participation in the DOD's PTSD platform trial. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, not being able to move forward with the development of SLS-002 after the anticipated end of Phase II meeting with the FDA, and not gaining marketing approvals for SLS-002 and/or its other product candidates; the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the results from the prior studies of SLS-002 may not be replicated or may be materially different from the results of Part 2 of the Phase II study of SLS-002); the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; the risks associated with the implementation of Seelos' business strategy; the risks related to raising capital to fund its development plans and ongoing operations; the risks related to Seelos' current stock price; as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York, NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-announces-receipt-of-minutes-from-its-end-of-phase-ii-meeting-with-the-united-states-food-and-drug-administration-fda-highlighting-modifications-to-the-primary-and-secondary-endpoints-of-its-phase-ii-study-of-302039967.html

SOURCE Seelos Therapeutics, Inc.

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