Tag: binge eating

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.

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.

Lead program, BMB-101, advances to IND-enabling toxicology studies with the aim of commencing human trials in 1H 2022

This Vancouver company is making advancements across its drug pipeline.

Bright Minds Biosciences (DRUG) selected Dravet Syndrome, a disorder that causes epilepsy from a young age, as the lead indication for its 5-HT2C formulation, BMB-101. In preclinical studies on zebrafish, BMB-101 was effective in reducing seizure duration and frequency and is now on track to be tested in human trials early next year.

In rat models, BMB-101 showed efficacy in treating opioid use disorder and binge eating disorder with rats demonstrating a 50% reduction in binge eating episodes.

The company also has a 5-HT2A + 5-HT2C mixed compound that is in preclinical development for cluster headaches, chemotherapy-induced peripheral neuropathy, and other pain disorders. Researchers are currently screening 5-HT2A compounds for depression as well.

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

Spent too much time gaming or had too much sex in 2021? 

We’re guessing you didn’t answer yes to both, but if you struggle with one of these things, ketamine therapy could help you make changes this year 😉

Awakn Life Sciences (AWKN) received ethics approval to expand its ketamine study. In addition to investigating Gambling Disorder, it will now cover three more behavioral addictions: Internet Gaming Disorder, Compulsive Sexual Behaviour, and Binge Eating Disorder.

The goal is to “harness a window in which the brain is able to make new connections” to create lasting behaviour changes. 

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