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MDMA treats PTSD + eating disorders simultaneously

MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD

Patients with PTSD often have eating disorders too. MDMA is known to improve self acceptance and emotional processing, so it may be the perfect treatment for both!

In MAPS’ Phase 3 trial on MDMA for PTSD, 42%* of patients scored in the “clinical” or “at-risk” range on an eating disorder scale prior to the treatment.

MDMA therapy was found to significantly reduce eating disorder symptoms in comparison to a placebo.

MAPS is commencing a multi-site Phase 2 trial this May to further examine MDMA therapy on both anorexia and binge eating.

*Patients with active purging were excluded as a precaution to avoid cardiac arrhythmias.

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NeonMind Announces Positive Preclinical Results Demonstrating the Efficacy of Psilocybin in Reducing Weight Gain in Obese Animal Subjects

NeonMind Announces Positive Preclinical Results Demonstrating the Efficacy of Psilocybin in Reducing Weight Gain in Obese Animal Subjects

ata Further Validates Psilocybin as a Drug Candidate for Obesity and Supports Development of NeonMind’s Drug Programs NEO-001 and NEO-002

OAKVILLE, ON / ACCESSWIRE / March 23, 2022 / NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBF)(FRA:6UF) (“NeonMind” or the “Company“), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, announced today it has released preclinical data demonstrating the efficacy of psilocybin in reducing weight gain in obese subjects. In previous preclinical studies, NeonMind has shown efficacy in reducing weight gain in healthy subjects with normal weight. This latest study suggests a broader therapeutic potential of psilocybin in weight management and supports the current development track of NeonMind’s drug candidates.

The data from NeonMind’s preclinical models revealed a novel finding for its drug candidates: the ability to target visceral fat. Increased visceral fat is linked to poorer cardiometabolic health and reduction in this type of fat is important in weight loss and better overall health outcomes. Additional findings from the preclinical models in obese subjects include:

  • Statistical significance compared to the control group for both absolute and relative weight gain;
  • Efficacy seen within days of administration;
  • Reduced food consumption compared to control group;
  • No safety signals.

The positive results further reinforce the drug development opportunity of NeonMind’s two lead psilocybin-based drug candidates targeting obesity. Moreover, the novel findings provide opportunities to enhance their commercial profiles. These candidates include NEO-001, which employs psilocybin as an agonist at the serotonin 5- HT2A receptor, and NEO-002, which utilizes low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.

“These latest findings show psilocybin’s ability to modulate weight gain, which is absolutely critical for any drug candidate targeting obesity and weight loss,” said Robert Tessarolo, President & CEO of NeonMind. “In two separate rodent studies, we have shown that psilocybin has efficacy in modulating weight in both obese and normal subjects. This is important given visceral fat is associated with increased comorbidities and poorer health outcomes. These findings show promise for the future development of psilocybin-based treatments for obesity, which may also lead to improved cardiovascular and metabolic health.”

Dr. Alasdair Barr, primary investigator of NeonMind’s preclinical study, commented, “These preclinical studies are bringing to light novel findings in an under-researched psychedelic modality: psilocybin-based weight management. We were able to explore key mechanisms that drive obese behavior and have come away with further evidence that psilocybin could potentially lead to a reduction in weight gain in various patient sub-types.”

The manuscript has been submitted to a leading industry peer-reviewed journal for publication.

About NeonMind Biosciences Inc.

NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.

In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind’s lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company’s second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.

NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.

Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101

Investor Relations:
KCSA Strategic Communications
Scott Eckstein/Tim Regan
neonmind@kcsa.com
Tel: 212-896-1210

The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind’s future performance. The use of any of the words “could”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind’s drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.

SOURCE: NeonMind Biosciences Inc.

View source version on accesswire.com:
https://www.accesswire.com/694257/NeonMind-Announces-Positive-Preclinical-Results-Demonstrating-the-Efficacy-of-Psilocybin-in-Reducing-Weight-Gain-in-Obese-Animal-Subjects

Released March 23, 2022

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Tryp Therapeutics Initiates Enrollment for Binge Eating Disorder Study in Partnership with University of Florida

Tryp Therapeutics Initiates Enrollment for Binge Eating Disorder Study in Partnership with University of Florida

Tryp Therapeutics (TRYP) began enrolling patients for a Phase 2 trial on psilocybin for binge eating. The company is using non-proprietary synthetic psilocybin to generate data quickly while developing a proprietary formulation.

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Can psilocybin treat the deadliest mental health disorder?

Recruitment for an upcoming trial – Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Anorexia has a higher mortality rate than any other psychiatric condition, as patients have a high risk of death by both suicide and organ failure.

Current treatments work for less than half of patients, which is why Imperial College London is preparing to study psilocybin therapy as an alternative. 

The school is recruiting female patients who have had a diagnosis for at least 3 years and have tried other forms of treatment without success. They’ll each receive 3 doses of psilocybin, and researchers will use several MRIs and EEG scans to understand the effects of the treatment.

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Awakn Life Sciences Expands World’s First Ketamine Study Beyond Gambling Disorder To Include Additional Behavioral Addictions

Awakn Life Sciences Expands World’s First Ketamine Study Beyond Gambling Disorder To Include Additional Behavioral Addictions

GROUNDBREAKING PSYCHEDLIC STUDY WILL INVESTIGATE BINGE EATING DISORDER, COMPULSIVE SEXUAL BEHAVIOR, AND INTERNET GAMING DISORDER

TORONTO, CANADA, 05 January 2022 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE:954) (Awakn), a biotechnology company developing and delivering psychedelic medicines to better treat addiction, announced today that it has received ethical committee approval to expand its existing ketamine study beyond Gambling Disorder to include three other behavioral addictions including Binge Eating Disorder, Compulsive Sexual Behaviour and Internet Gaming Disorder.

The basket study, which will be another world’s first, is led by Prof. Celia Morgan, Awakn’s Head of Ketamine-Assisted Therapy for Addiction, Professor of Psychopharmacology at the University of Exeter, U.K., and an internationally respected expert in the therapeutic use of ketamine. Professor Morgan’s work will investigate a new treatment approach for these behavioral addictions, trying to harness a window in which the brain is able to make new connections. The study will explore and monitor whether the ketamine can increase neuroplasticity using EEG (Electroencephalogram).

Professor Morgan commented, “We are delighted to expand this research and to make further inroads into a treatment area that has had no material pharmacological advancements in far too long, all the while the number of people suffering has steadily increased. We hope this will give us valuable insights to push our ketamine program forward and help these people as quickly as possible.”

There are currently no licensed pharmacological treatments for behavioral addictions or disorders available, and the need to find new and effective treatment options has never been more important. Behavioural addictions have devastating consequences for individuals and their families, affecting physical and mental health, and increasing mortality from suicide. The global populations affected by behavioural addictions are massive with Binge Eating Disorder affecting up to 110 million people; Internet Gaming Disorder affecting 238 million; Sexual Compulsive Behaviour affecting up to 350 million; and Gambling Disorder up to 450 million people.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company, researching, developing, and delivering psychedelic medicine to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat addiction. Awakn will also deliver evidence backed psychedelic therapies for addiction in clinics in the UK and Europe and through licencing partnerships globally. 

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 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.

Investor Enquiries:
KCSA Strategic Communications
Valter Pinto / Tim Regan
Phone: +1 (212) 896-1254
Awakn@KCSA.com

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

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

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How psilocybin treats eating disorders

Tryp Therapeutics: An Interview with Jim Gilligan Ph.D.

Over-eating disorders occur when the brain is not providing the patient with a signal to feel full. 

According the the Chief Scientific Officer of Tryp Therapeutics (TRYP), psilocybin therapy could be used to correct the malfunctioning neural network while helping patients work through food-related anxiety. 

This week, the company got the go-ahead from the FDA to continue its binge eating study, so we’ll soon know if the theory holds true!

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Clearmind Medicine Launches Study for Binge Eating with The Hebrew University Using its Proprietary MEAI Compound

Clearmind Medicine Launches Study for Binge Eating with The Hebrew University Using its Proprietary MEAI Compound

‍Focus on the discovery and development of novel therapeutic strategies to treat obesity and its related metabolic disorders

TORONTO, Nov. 24, 2021 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (CSE: CMND, FSE: CWY0, OTC Pink: CMNDF), (“Clearmind” or the “Company”), a psychedelic medicine biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and undertreated health problems, is pleased to announce it has signed an agreement to fund a new research and development project with the Hebrew University of Jerusalem’s Obesity and Metabolism Laboratory, to evaluate the Company’s proprietary compound, MEAI’s direct effect on binge eating including food and water intakes as well as activity and metabolic parameters.

The study, which will be overseen by Prof. Joseph (Yossi) Tam, D.M.D., Ph.D., head of the Obesity and Metabolism Laboratory and Associate Professor of Pharmacology at the Hebrew University’s Institute for Drug Research, will focus on testing the potential of MEAI to treat binge eating and related behaviors, and will support the discovery and development of novel therapeutic strategies to safely treat obesity and its associated metabolic disorders.

Increasingly prevalent in developed nations, the conditions of being overweight and obese are a serious health concern as they contribute to so many other conditions, including heart disease, stroke, type 2 diabetes, fatty liver disease, and certain types of cancers, some of the leading causes of preventable, premature death in the US. The Center for Disease Control and Prevention estimates that about 74% of adults in the US are overweight1 and over 40% are considered obese2. According to a recent study published in 2020, this phenomenon is also accompanied with the high and rising costs of obesity to the US Health Care system at an estimated annual medical cost for the full non-institutionalized population of adults, in 2013, equaling $342.2 billion.

Adi Zuloff-Shani, Ph.D., CEO of Clearmind, commented on the announcement, “The medical community has yet to establish an effective therapeutic or preventative treatment for obesity, despite its increasing prevalence and severe negative impacts on the medical and economic health of people around the world. Clearmind has been able to demonstrate the positive influence MEAI has on binge behavior with regard to alcohol use, and our preliminary research indicates it may have a similar effect on metabolic disorders.”

Prof. Tam added, “I have spent my career exploring the biological mechanisms underlying obesity and the metabolic syndrome, intending to develop an effective drug therapy. After viewing the early data on MEAI, I am optimistic that this compound has the potential to be a building block for a real solution and look forward to working with the Clearmind team to advance our shared objective.”

The first phase of the three-stage study will focus on assessing the direct effect of MEAI on food and water intakes as well as its ability to modulate activity and metabolic parameters.

Following the initial screening, the study will evaluate MEAI’s efficacy as a therapeutic metabolic agent on a high-fat diet-induced obese mouse model, by measuring MEAI’s potential to treat obesity, hepatic injury, glycemic and hormonal imbalance. Lastly MEAI’s binge eating and drinking mitigating properties will be determined by comparison of cumulative food and sucrose preference, respectively.

About Clearmind Medicine Inc.

Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of four patent families. The first, “Binge Behavior Regulators”, has been granted in the U.S., Europe, China and India, with pending divisional applications in Europe and the U.S. The second, “Alcohol Beverage Substitute”, has been approved for a European patent, with pending applications in the U.S., China and India. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on the Canadian Securities Exchange under the symbol “CMND“, the Frankfurt Stock Exchange under the symbol “CWYO” and on the OTC Pink under the symbol “CMNDF“.

For further information, please contact:
Investor Relations,
Email: invest@clearmindmedicine.com
Telephone: (778) 400-5347
General Inquiries,
Info@Clearmindmedicine.com
www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Such statements include discussion of the new research and development project with the Hebrew University of Jerusalem’s Obesity and Metabolism Laboratory and the benefits of product candidate. There is no certainty that any of these events will occur. Although such statements are based on management’s reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances.

Investing into early-stage companies inherently carries a high degree of risk, and investment into securities of the Company shall be considered highly speculative.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities in any province in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under the Private Placement have not been, and will not be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Neither the Canadian Securities Exchange (the “CSE”) nor its Regulation Services Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

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Tryp Therapeutics Announces Advancement of Phase 2a Clinical Trial in Binge Eating Disorder

Tryp Therapeutics Announces Advancement of Phase 2a Clinical Trial in Binge Eating Disorder

SAN DIEGO – December 23, 2021 – Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (“Tryp” or the “Company”), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today the receipt of correspondence from the U.S. Food and Drug Administration (FDA) affirming the Company’s ability to proceed with a Phase 2a clinical trial evaluating the use of synthetic psilocybin for binge eating disorder.

Tryp previously announced on October 20, 2021 a clinical hold placed on the study by the FDA. The Company provided an update on the matter on November 18, 2021 and submitted an amendment to the FDA for the Investigational New Drug (IND) application on December 9, 2021. Through the notice received this week, the FDA removed the clinical hold and advised Tryp that it can continue with the study.

Commenting on the development, Chairman and CEO Greg McKee said, “We are excited to move forward with our Phase 2a clinical trial in binge eating disorder through our partnership with the University of Florida. Our dialogue with the FDA has been productive and has meaningfully improved the design of this study. This represents the second clinical study in 2021 that we have received authorization from the FDA to initiate.”

About Tryp Therapeutics

Tryp Therapeutics is a pharmaceutical company focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders (PFN™) program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of chronic pain and other indications. The Company has announced upcoming Phase 2a clinical trials with the University of Michigan and the University of Florida to evaluate its drug products for fibromyalgia and overeating disorders, respectively. Tryp is also developing a proprietary psilocybin-based product, TRP-8803, that uses a novel formulation and route of administration to improve the patient experience. For more information, please visit www.tryptherapeutics.com.

Investor Inquiries:

Joseph Green

Edison Group

investors@tryptherapeutics.com

Media Inquiries:

Abby Berger
KCSA Strategic Communications
Tryp@KCSA.com

1-833-811-8797

Forward-Looking Information

Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans,” “targets,” “expects” or “does not expect,” “is expected,” “an opportunity exists,” “is positioned,” “estimates,” “intends,” “assumes,” “anticipates” or “does not anticipate” or “believes,” or variations of such words and phrases or state that certain actions, events or results “may,” “could,” “would,” “might,” “will” or “will be taken,” “occur” or “be achieved.” In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

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Psychedelics → spirituality → emotional regulation → happiness

Study suggests psychedelics promote positive mental health through increased spirituality and emotion regulation

A recent survey shows that spirituality increases with psychedelic use, and that increased spirituality is linked to improved emotional regulation. The findings suggest that better emotional regulation is associated with decreased scores for depression, anxiety, and disordered eating.

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