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Clairvoyant Initiates First Site for Phase 2 Psilocybin Therapy Clinical Trial for Alcohol Use Disorder

Clairvoyant Initiates First Site for Phase 2 Psilocybin Therapy Clinical Trial for Alcohol Use Disorder

VANCOUVER, BC / ACCESSWIRE / July 6, 2022 / Clairvoyant Therapeutics, a Canadian biotech company, is pleased to announce it has initiated the first of 15 planned sites for CLARITY, the company’s Phase 2 clinical trial investigating psilocybin in the treatment of alcohol use disorder (AUD) (formerly called alcoholism).

CLARITY is a randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of 25 mg synthetic psilocybin in conjunction with Motivational Enhancement Therapy (MET). CLARITY has been approved in Canada and has been submitted for regulatory approval in the EU countries selected for its Phase 2 clinical trial.

“We are delighted to initiate our Phase 2 clinical trial,” said Damian Kettlewell, co-founder and CEO of Clairvoyant. “At Clairvoyant, it is our hope that the results of this clinical trial will support the company’s novel psychedelic treatment model for addressing the significant unmet medical need for AUD patients.”

The remainder of the 15 sites are each in an advanced stage of negotiation. These sites are located in major centres in Canada and Europe. The large number of sites for a psychedelic trial reflects Clairvoyant’s objective to be the first company globally to register psilocybin as a therapeutic product to treat AUD patients.

About Alcohol Use Disorder

According to the World Health Organization, 283 million people aged 15 years and older are at risk of alcohol use disorder.[i] Globally, mortality from alcohol consumption is higher than from diseases such as tuberculosis, HIV/AIDS and diabetes.[i]

About Psilocybin Therapy and CLARITY

Psilocybin is the pharmaceutical agent in certain mushrooms which is known to induce a temporary psychedelic state. It was first purified in the 1950s. After thousands of recorded administrations, no addiction or abuse potential has been identified for psilocybin. In the CLARITY trial, subjects are accompanied on their psychedelic treatment journey by two highly trained therapists who have been certified under Clairvoyant’s professional and ethical certification program.

About Clairvoyant

Clairvoyant Therapeutics is a Canadian biotechnology company changing the face of psychedelic therapy with a speed-to-market clinical strategy designed to enable psilocybin therapy in the EU, UK & Canada to treat patients living with Alcohol Use Disorder (AUD) beginning in 2026.

The company’s exceptional team, with a proven clinical track record and deep drug development experience, has made Clairvoyant the most advanced company globally developing psilocybin therapy for the treatment of AUD.

Clairvoyant is committed to meeting the highest standards of verified social and environmental performance, public transparency and legal accountability to balance profit and purpose and is a pending B Corporation Certification. Clairvoyant is a member of Life Science BC and Biotechnology Innovation Organization (BIO).

Learn more at www.clairvoyantrx.com and follow the Company on LinkedIn and Twitter.

For more information:

Media requests:
Marlo Taylor
mtaylor@gagecommunications.ca

Corporate contact:
Damian Kettlewell
damian@clairvoyantrx.com

[i] World Health Organization. Global alcohol action plan 2022-2030 to strengthen implementation of the Global Strategy to Reduce the Harmful Use of Alcohol First draft. June 2021

SOURCE: Clairvoyant Therapeutics

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Awakn Receives UK State Funding to Identify Optimal Pathway to Market In UK & US For Its Lead Clinical Development Program – Ketamine-Assisted Therapy For Alcohol Use Disorder

Awakn Receives UK State Funding to Identify Optimal Pathway to Market In UK & US For Its Lead Clinical Development Program – Ketamine-Assisted Therapy For Alcohol Use Disorder

Awakn Provides Business Update on Progressing its Lead Program from Phase II b to Phase III

TORONTO, CANADA, July 05, 2022 – Awakn Life Sciences Corp. (NEO: AWKN, OTCQB: AWKNF, FSE: 954), a revenue-generating biotechnology company researching, developing and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), is pleased to announce it has secured funding from Innovate UK to identify the quickest and most cost-effective route to market in both the UK and the US for Awakn’s lead program – proprietary ketamine-assisted therapy for treating AUD. Innovate UK is the UK’s national innovation agency which provided the funding in an initiative delivered jointly by CPI and ABHI.

Awakn’s activities will be delivered in collaboration with Veristat, a global Clinical Research Organization (CRO) that specialises in accelerating client therapies through the clinical development process into regulatory approval and commercialization. Veristat supported marketing applications for 12% of all US Food and Drug Administration (FDA) Novel Drug Approvals in 2021.  

Awakn’s Chief Scientific Officer, Shaun McNulty commented: “Our Phase II a/b ‘KARE’ study, led by Professor Celia Morgan, showed that ketamine-assisted therapy has the potential to revolutionize the treatment of AUD.  This funding enables Awakn, working closely with Veristat, to bring a much-needed effective treatment approach to the market as soon as possible.  Delivering this innovative therapeutic approach as rapidly as possible to patients in the UK and the US is critical to address this major unmet medical need.”

Anthony Tennyson Awakn’s CEO added: “Securing these funds from Innovate UK is a major endorsement of our efforts and approach to developing new and effective treatments for addictions.  Our Lead program has all the right components to make a lasting difference for the very significant number of people who are suffering from AUD.   We are also delighted to be working with a partner of the calibre of Veristat and to have the ability to benefit from their significant expertise. The addiction treatment market opportunity is, unfortunately, large and growing, and Awakn is uniquely positioned to offer proven therapeutics supported by data to sufferers for whom the current standard of care is inadequate and relapse rates are unacceptably high.

Project Kestrel

Awakn is also providing a business update on its lead program. Awakn has renamed its lead program to Project Kestrel. Project Kestrel will aim to deliver marketing authorization/regulatory approval for ketamine-assisted therapy to treat AUD in both the UK and the US with clear Intellectual Property (IP) surrounding the treatment.  Project Kestrel builds on Awakn’s successful Phase II a/b ‘KARE’ clinical trial and efficacy data released in January 2022, which demonstrated safety and efficacy as a new treatment option for AUD patients.

Awakn has started planning and intends to initiate a Phase III trial in the UK in 2022 as a prelude to initiating a further Phase III trial in the US thereafter.  Both are designed to provide the key data necessary to bring Project Kestrel to the market as soon as possible.  Awakn has also applied for a grant to the National Institute for Health and Care Research (NIHR) in the UK to cover two-thirds of the cost of the planned UK Phase III trial and a decision on this application is anticipated shortly.

The outputs from Project Kestrel will benefit all of Awakn’s Research and Development project portfolio by defining a clear regulatory pathway for drug-assisted therapies to treat not only AUD but also a broad range of other behavioral addictions which Awakn is developing therapies for.

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a revenue-generating biotechnology company researching, developing, and commercialising therapeutics to treat substance and behavioral addictions.  Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 400m people globally for which the current standard of care is inadequate. Our goal is to provide effective therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels. 

www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

About Project Kestrel

Project Kestrel is the lead clinical development program of Awakn Life Sciences.  Project Kestrel is supported by Awakn’s Phase II a/b ‘KARE’ clinical trial which examined ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD).  The trial resulted in patients experiencing on average 86% abstinence at 6 months post treatment versus 2% before the trial which means that study participants went from being sober on average 7 days a year to being sober on average 314 days a year.  Awakn is planning to initiate a Phase III trial in the UK in 2022 and plans to seek regulatory approval in the UK and the US in due course.

About Veristat

Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 27 years of experience in clinical trial planning and execution, Veristat is equipped to support any development program. The company has prepared nearly 100 marketing applications for approval with global regulatory authorities in the last 10 years. 

https://www.veristat.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@awaknlifesciences.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

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Largest psychedelic neuroimaging study to date

UNITy: World’s first study of how DMT-induced brain changes predict improved wellbeing

University College London is raising funds for the world’s largest brain imaging study on psychedelics, aka Project UNITy.

In the first phase of the study, 150 people will receive three brain scans: one while watching a movie, one while dosed with DMT or a placebo, and another while watching a movie post-DMT trip or placebo.

Then, researchers will use an app to track participants’ changes in wellbeing for one year. 

The study will reveal which specific brain networks are altered on DMT (such as those related to vision, memory, or language), as well as which networks are linked to positive changes in wellbeing.

If successful, a second phase of the study will be conducted to see if DMT can reduce alcohol consumption and “reactivate” memory networks in hazardous drinkers.

Those who make a contribution to the study can receive goodies like trippy artwork, event tickets, and even a dinner with the scientists.

Learn more

PDF of article

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Clearmind Announces Successful Pre-IND Meeting with U.S. FDA for CMND-100 for Alcohol Use Disorder

Clearmind Announces Successful Pre-IND Meeting with U.S. FDA for CMND-100 for Alcohol Use Disorder

Clearmind aims to initiate clinical trials with CMND-100 by year’s end‍

VANCOUVER, May 26, 2022 — Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF, FSE: CWY0) (“Clearmind” or the “Company“), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, has completed a highly constructive Pre-Investigational New Drug Application (“pre-IND“)meeting with the U.S. Food and Drug Administration (“FDA“) to discuss the development of the Company’s MEAI- based proprietary compound CMND-100.‍

“The FDA’s interest in CMND-100 as a potential therapy for alcohol use disorder was extremely encouraging,” said Dr. Adi Zuloff-Shani, Clearmind’s CEO. “Their feedback to the proposed development program was positive, and we are working diligently towards initiating the clinical trials with CMND-100 by the end of 2022.”‍

CMND-100, Clearmind’s lead product that is based on MEAI, a novel psychoactive compound, exerts a significant reduced desire to consume alcoholic beverages, and the company is developing it as a candidate therapy for the treatment of Alcohol Use Disorder(“AUD“). Clearmind submitted a pre-IND meeting package to the FDA in April; it included an overview of the development program, and questions about the regulatory requirements for opening an investigational new drug (“IND“) application.‍

Opening an IND is required for conducting clinical trials in the United States and ensures that trials are designed in accordance with the data requirements for FDA marketing approval.The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive.‍

“It’s critical to have such open discussions with regulatory officials. It helps us efficiently and effectively follow the requirements and guidance toward approval,”Zuloff-Shani said.‍

AUD is a chronic relapsing brain disorder characterized by an impaired ability to stop or control alcohol use despite negative social, occupational, or health consequences. Alcohol is the third most-common preventable cause of death in the United States, where an estimated 5.8% of the population (over 18 million people) struggle with the condition. It is assumed that CMND- 100 suppresses the desire to drink alcohol by potentially innervating neural pathways such as 5-HT1A that lead to “sensible behavior.”

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 five patent families. 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 “CWY0” and on the OTCMarkets under the symbol “CMNDF“.

For further information, please contact:
Investor Relations,
Email: invest@clearmindmedicine.com
Telephone: (604) 260-1566
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 submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. 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 CanadianSecurities 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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Clearmind Medicine Announces Successful Pre-Clinical Results in MEAI Treatment for Alcohol Consumption

Clearmind Medicine Announces Successful Pre-Clinical Results in MEAI Treatment for Alcohol Consumption

Pre-clinical trial demonstrated high safety profile in addition to a significant suppressive effect on alcohol consumption

VANCOUVER, May 19, 2022– Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF, FSE: CWY0) (“Clearmind” or the “Company”, a biotech company focused on discovery and development of novel psychedelic-derived therapeutics, today announced positive safety results of its proprietary molecule, MEAI, to treat alcohol abuse.

To evaluate the efficacy and safety of its psychedelic-derived treatment, Clearmind conducted preclinical trials, training groups of mice to consume alcohol for five weeks. The groups were then given varying daily doses of the new treatment, with intermittent access to alcohol and water. After two weeks, researchers found a significant reduction in alcohol consumption in mice receiving the treatment. The control group showed no statistical significant reduction.

Today’s safety results build on these positive efficacy findings and mark a significant milestone as Clearmind expects to conduct FDA-regulated clinical trials with humans later this year.

“We are tremendously pleased with the success of our preclinical trials to date, which have now demonstrated both safety and efficacy in reducing alcohol consumption,” said Dr. Adi Zuloff-Shani, Clearmind’s Chief Executive Officer “We believe that our novel, psychedelic-based treatment has the potential to help millions around the world suffering from alcohol abuse, along with a range of other mental health challenges. We look forward to our continued progress.”

Following the behavioral paradigm and to evaluate safety, histopathological testing was conducted on selected organs (heart, lungs, liver, kidneys, brain, pancreas, spleen, and thyroid gland) of tested animals to determine possible toxicological effects of MEAI. No treatment-related histological changes were observed amongst all MEAI treatment groups compared to control naive and vehicle animals in all the examined organs.

About Clearmind Medicine

Clearmind Medicine is a new biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder, binge eating and depression.

The Israeli-Canadian company holds several patents for the non-hallucinogenic compound MEAI. 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 “CWY0” and on the OTC pink under the symbol “CMNDF“.


For further information, please contact:
Investor Relations,
Email: invest@clearmindmedicine.com
Telephone: (604) 260-1566
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 submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. 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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Clearmind Announces Pre-IND Meeting Date with FDA

Clearmind Announces Pre-IND Meeting Date with FDA

Clearmind aims to initiate clinical trials with CMND-100 by year’s end

Vancouver, May 13, 2022 — Clearmind Medicine Inc. (CSE: CMND, OTC Pink:CMNDF, FSE: CWY0) (“Clearmind” or the “Company“), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under treated health problems, today announced that it will meet with the Centre for Drug Evaluation and Research (“CDER”) of the U.S. Food and Drug Administration (“FDA”) on Wednesday, May 18, 2022. The meeting is to discuss numerous aspects of Clearmind’s planned First in Human (“FIH”) study evaluating its proprietary drug candidate CMND-100 for the treatment of Alcohol Use Disorder (“AUD”).

Clearmind’s CEO, Dr. Adi Zuloff-Shani, commenting on the meeting said “The meeting with the FDA is an important next step in the advancement of our program in treatment of AUD. We recently submitted questions to the FDA as part of our pre-IND submission package. With answers to these questions and any additional information provided by the FDA during the meeting, we will be in position to address any open issues or requests of the FDA before submitting our IND. Once the IND is submitted and found to be acceptable to the FDA, we will initiate our planned FIH study in treatment of AUD.”

“This pre-IND meeting continues our diligent work towards initiating the clinical trial with CMND-100 by the end of 2022, which is of foremost importance to Clearmind in its aim to be a leader in developing psycho-targeted pharmaceuticals,” said Zuloff-Shani.

Clearmind’s lead product, CMND-100, is a novel psychedelic-derived drug candidate, exerting a significant reduced desire to consume alcoholic beverages.

Clearmind’s CMND-100 is designed to meet a clear unmet medical need in patients with AUD. AUD is a chronic relapsing brain disorder characterized by an impaired ability to stop or control alcohol use despite negative social, occupational, or health consequences. Alcohol is one of the world’s biggest health problems, which costs the United States alone $250 billion each year and is the third most-common preventable cause of death in the US. It is assumed that CMND-100 suppresses the decision to drink more alcohol by potentially innervating neural pathways such as 5-HT1A that lead to “sensible behaviour”.

Clearmind’s intellectual property portfolio includes issued patents in the US, Europe, China and India covering the use of CMND-100 in the treatment of AUD.

‍

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.

TheCompany’s intellectual portfolio currently consists of four patent families.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 Markets under the symbol “CMNDF“.

‍

For further information, please contact:
Investor Relations,
Email: invest@clearmindmedicine.com
Telephone: (604) 260-1566
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 submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. 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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Clearmind Medicine Inc. and SciSparc Ltd., Collaboration Yields New Provisional Patent Application for Psychedelic Combination Treatment for Binge Behaviors

Clearmind Medicine Inc. and SciSparc Ltd., Collaboration Yields New Provisional Patent Application for Psychedelic Combination Treatment for Binge Behaviors

Pre-clinical trials based on proprietary combination demonstrate significant suppressive effect on alcohol consumption

TORONTO, May 10, 2022 —  Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF, FSE: CWY0) (“Clearmind” or the “Company“), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major undertreated health problems, today announced the filing of a provisional patent application, related to a psychedelic combination therapy treating binge behaviors that results from its recently launched collaboration with SciSparc Ltd. (NASDAQ: SPRC).

SciSparc is a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system. The patent application refers to the combination of Clearmind’s MEAI, a novel proprietary psychedelic treatment for addictions and binge behaviors with SciSparc’s CannAmide™.

The patent application followed a successful pre-clinical study that showed a significant dose-dependent effect for MEAI treatment in reducing alcohol consumption of treated animals, with additional significant effect for the CannAmide™ treatment at the lower, sub-effective MEAI dose.

“Clearmind continues to expand its IP portfolio and pave its way as the holder of the most significant patent portfolio in the industry,” said Dr. Adi Zuloff- Shani, Clearmind’s Chief Executive Officer. “Clearmind’s patent portfolio, built around technologies we developed, is unique in the psychedelic field. This patent application results from the successful pre-clinical results we announced in March, making a wider collaboration with SciSparc a natural progression.”

Initial results of the pre-clinical, on mice, study showed that alcohol consumption was significantly reduced following treatment with MEAI at a dose of 40 mg/kg and at higher doses (p<0.01) compared to consumption before treatment. Alcohol consumption was significantly reduced following dual treatment with 25 mg/kg CannAmide™ in addition to MEAI at a dose of 20 mg/kg, again compared to consumption before treatment.

The mice were provided with 20% alcohol solution for 24 hours three times a week for seven weeks, and were treated every day with MEAI or the combination of MEAI and CannAmide™ during the last two weeks of alcohol treatment. The alcohol consumption was measured by weighing the alcohol bottles before and after; and water consumption was measured similarly in parallel.

‍

About Clearmind Medicine Inc.

Clearmind is a new biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder.

The Israeli- Canadian company holds several patents, among other, for the non-hallucinogenic compound MEAI. 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 “CWY0” and on the OTC pink under the symbol “CMNDF“.

‍

About SciSparc (NASDAQ:SPRC)

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. Our focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 for the treatment of Tourette syndrome, for the treatment of obstructive sleep apnea and Alzheimer’s disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of autism spectrum disorder and status epilepticus.

‍

For further information, please contact:

Investor Relations
invest@clearmindmedicine.com
Telephone: (604) 260-1566
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 submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. 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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Participate in psychedelic research

If you’ve been wanting to try psychedelic therapy legally, now’s your chance!

Johns Hopkins is recruiting participants for a number of psilocybin studies on:

Plus, Nova Mentis is recruiting both autisitc and neurotypical patients for an observational study that will lead to a psilocybin microdosing study.

If you want to contribute to psychedelic research from home, check out Johns Hopkins’ online surveys on psychedelics and breathwork for anxiety, depression, and PTSD.

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Psychedelic blocks the rewarding effects of alcohol 🍾

Ibogaine blocks some of the rewarding effects of alcohol in rodent model of addictive behavior

A common model of addiction involves conditioning rats to associate a drug with a certain area. The amount of time the rat spends in that area indicates how addictive the stimuli is.

In a recent study, rats showed a preference to the area associated with ethanol (alcohol) over the placebo area, which was expected since alcohol is addictive. 

After a dose of ibogaine (a psychedelic compound found in the African iboga shrub), they no longer expressed a preference for alcohol.

Additionally, rats showed no preference between an area associated with ibogaine and the placebo area, suggesting that ibogaine is non-addictive.

“We found that ibogaine did not have rewarding effects itself, but it did block the expression of ethanol reward in a model that can commonly be referred to as a pre-clinical model of relapse,” explains the study author, Lais F. Berro.

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Clearmind Medicine Announces Positive Results on CMND-100 trials

Clearmind Medicine Announces Positive Results on CMND-100 trials

wo pre-clinical trials based on MEAI exhibited a significant suppressive effect on alcohol consumption in mice

TORONTO, March 17, 2022(GLOBE NEWSWIRE) —  Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF,FSE: CWY0) (“Clearmind” or the “Company”) today announced promising results from two pre-clinical trials which tested suppression of alcohol consumption in mice using its novel psychedelic-based therapeutic CMND-100, whose active pharmaceutical ingredient is MEAI.

The first trial examined the effect of CMND-100 in several doses as a monotherapy. The second, done in collaboration with SciSparc Ltd. (NASDAQ: SPRC), examined the synergetic effect of combining lower concentrations of CMND-100 with SciSparc’s CannAmide™(proprietary formulation of Palmitoylethanolamide or PEA) .

“We are excited to reveal that our proprietary CMND-100 showed very positive results that suggest strong potential for treating alcohol use disorder,” said Dr. Adi Zuloff-Shani, PhD, the CEO of Clearmind, which focuses on discovery and development of novel psychedelic-derived therapeutics to solve major undertreated health problems.

As part of the trials, the mice were provided with a 20% alcohol solution for 24 hours, three times a week for 7 weeks – and treated with MEAI daily during the last two weeks. The mice had free access to water to test their alcohol preference over water.Alcohol consumption was measured by weighing the alcohol bottles before and after. CMND-100 at doses of 40 mg/kg and higher demonstrated significant suppressive effect on alcohol consumption, reducing the alcohol consumed significantly lower than untreated controls (p<0.01).

The second trial aimed to test the hypothesis that sub-effective doses of CMND-100 in combination with CannAmide will further attenuate alcohol consumption (PEA is known as a safeneuro-potentiator). Results showed a significant reduction in alcohol consumption at the lower sub-effective MEAI dose when combined with CannAmide.

“CMND-100 showed very positive results both in our own target dose and in lower doses combined with SciSparc’s CannAmide™,” Zuloff-Shani said. “These results are a proof of concept for our goal of developing innovative, effective, and safe psychedelic treatments that could revolutionize the mental health market

    
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 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”.

About SciSparc(NASDAQ:SPRC):

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. Our focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 for the treatment of Tourette syndrome, for the treatment of obstructive sleep apnea and Alzheimer’s disease and agitation; SCI-160 for the treatment of pain; andSCI-210 for the treatment of autism spectrum disorder and status epilepticus.

For further information, please contact:

Investor Relations
invest@clearmindmedicine.com
Telephone: (604) 260-1566
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 submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. 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.

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