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Mydecine Receives Conditional IRB Approval for Phase 2b Smoking Cessation Study

Mydecine Receives Conditional IRB Approval for Phase 2b Smoking Cessation Study

Clinical trial programs advance to further assess psychedelic-assisted psychotherapy utilizing lead drug candidate MYCO-001

DENVER, March 24, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced it has received conditional approval from the Institutional Review Board (IRB) for its multi-site Phase 2b smoking cessation trial. Johns Hopkins University will serve as the lead investigational site.

The Company reported the IRB has approved its Phase 2b smoking cessation study pending FDA approval of its Investigational New Drug (IND) application. Mydecine plans to submit the IND application in Q2 2022 and is hopeful it will go into effect 30 days after submission.

“We are beyond excited to share the news of our conditional IRB approval for our Phase 2b clinical trial. Upon the near-term clearance of our IND application, which is wholly owned by Mydecine, we will be the first commercial IND approved utilizing psilocybin for the indication of smoking cessation, and one of a small number of organizations with a commercial FDA IND approval, alongside COMPASS Pathways, MindMed, and Usona, for a Phase 2 or later stage study assessing a psychedelic compound for any indication. We have a strong patent and regulatory strategy to support this initiative as well as further subsequent approvals,” said CEO Josh Bartch.

“This conditional approval marks a significant milestone not only for Mydecine but for people around the globe. The total economic cost of smoking has been estimated to be more than $300 billion per year in the United States alone. Our mission is to bring safer, more effective solutions to address nicotine dependence and other harmful addictions. This conditional approval brings us one step closer to potentially having a positive effect on millions of lives utilizing this innovative treatment program,” said Mydecine’s Chief Medical Officer Dr. Rakesh Jetly.

“Today’s accomplishment speaks to the perseverance and dedication of our team as we continue to build on our clinical and commercial potential,” added Mydecine’s Senior Director of Clinical and Regulatory Affairs Jessica Riggleman. “Our success is built upon a strategic collaboration between our contract research organization, manufacturer, investigators, advisors and regulatory consultants. We are diligently working together to submit our Investigational New Drug Application to the FDA for our multi-regional Phase 2b clinical trial.”

The Company will move rapidly into the patient recruitment phase upon FDA clearance. Mydecine’s Phase 2b study is investigating a primary endpoint of six months, indicating it could publish data as early as Q4 2023.

Sign-up for Mydecine’s newsletter by scrolling to the bottom of this page.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter, LinkedIn, YouTube and Instagram.

For more information, please contact:
Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com

Investor Relations
Morgan Kervitsky, Director of Marketing
contact@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

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Mydecine Reports Positive Pre-IND Meeting With FDA For MYCO-001 Smoking Cessation Study

Mydecine Reports Positive Pre-IND Meeting With FDA For MYCO-001 Smoking Cessation Study

Company rapidly prepares to submit IND and Breakthrough Therapy Status Applications

DENVER, March 01, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced a positive meeting with the Food and Drug Administration (FDA) regarding their Investigational New Drug (IND) and breakthrough therapy status applications.

The Company reported a meeting with the FDA on February 28th to review their IND application to administer MYCO-001, in combination with therapy, to humans as part of smoking cessation treatment. Leading drug and substance abuse researcher, Dr. Matthew Johnson of Johns Hopkins University, will serve as the lead investigator for this multi-site study.

“The data from John Hopkins University’s ongoing studies assessing psychedelic-assisted therapy to treat nicotine addiction is showing efficacy rates 2-3 times higher than the current gold standard of treatment. Our team is eager to start collecting the data needed to bring an approved drug product to market that could potentially save millions of lives,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.

“Mydecine plans to submit a request for Breakthrough Therapy designation with our IND submission. Psilocybin-assisted therapy has shown meaningful advantages over available medications for tobacco addiction including significant increases in safety and efficacy. We are looking forward to closely working with the FDA to bring safer and more effective therapy to the millions of people who are trying to quit smoking across the globe,” said Mydecine’s Senior Director of Clinical and Regulatory Affairs, Jessica Riggleman.

“We had an extremely positive meeting with the FDA in regards to our proposed smoking cessation study. The FDA provided helpful feedback on our study design that we will implement. We are now working rapidly in preparing our IND submission for the 2B portion of the study which we believe will be next month. Once cleared, we will move swiftly into patient recruitment. This is a study we have been diligently working on over the last two years and we’re excited to continue moving it forward,” said Mydecine CEO Josh Bartch.

Sign-up for Mydecine’s newsletter by scrolling to the bottom of this page.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter, LinkedIn, YouTube and Instagram.

For more information, please contact:
Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com

Investor Relations
Morgan Kervitsky, Director of Marketing
contact@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

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Mydecine Submits Pre-Investigational New Drug Briefing Package to the FDA for MYCO-001 Seamless Phase 2/3 Smoking Cessation Clinical Trial

Mydecine Submits Pre-Investigational New Drug Briefing Package to the FDA for MYCO-001 Seamless Phase 2/3 Smoking Cessation Clinical Trial

DENVER, Feb. 01, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today announced in preparation for its FDA pre-Investigational New Drug (IND) meeting on February 28th, the company has submitted a pre-IND briefing package to the U.S. Food and Drug Administration (FDA) for a clinical study evaluating MYCO-001 in a structured smoking cessation treatment program.

The study will be led by Principal Investigator Dr. Matthew Johnson, Ph.D., Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University. The university is the flagship site of the planned placebo-controlled study, which will assess the safety and efficacy of psilocybin-assisted psychotherapy utilizing MYCO-001 to treat tobacco addiction.

“We are excited to move forward on this important study, and our team has been working diligently to ensure that our pre-IND package is complete,” said Mydecine CEO Josh Bartch. “Tobacco use is the greatest single, preventable cause of death in the world,” he added, “yet there are few safe and effective treatments for nicotine addiction. As the only company currently investigating a psilocybin compound for smoking cessation, Mydecine is proud to be at the forefront of this research.”

The planned study will build on previous smoking cessation studies conducted by Dr. Johnson and his team at Johns Hopkins University. In their ongoing trial, 59% of participants who received psychedelic-assisted therapy remained abstinent from smoking at 12 months, compared to only 28% of patients who received the transdermal nicotine patch.

Mydecine’s Phase 2/3 study is projected to launch in Q2 2022 and will be looking at primary endpoints of three and six months. A combined-phase or operationally seamless clinical trial, such as this one, combines two or more phases into one study and uses results acquired throughout the trial to adjust the course of the study. This design can use resources more efficiently and often can be more informative than a traditional fixed study.

“Even with a wide variety of approved treatments on the market, tobacco addiction continues to remain largely untreated,” added Mydecine CMO Dr. Rakesh Jetly. “With safety and efficacy concerns about current therapies, including the recall of the blockbuster treatment Chantix, there is a strong need for innovative and improved treatment options.”

According to the Centers for Disease Control and Prevention (CDC), cigarette smoking is responsible for one out of every five deaths in the United States, roughly 480,000 people every year. Approximately 34.1 million Americans currently smoke cigarettes. About 68% have stated they would like to quit smoking, and 55% have made an attempt to quit, yet only 7.5% are successful.

Sign-up for Mydecine’s newsletter by scrolling to the bottom of this page.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter, LinkedIn, and Instagram.

For more information, please contact:
Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com 

Investor Relations
Morgan Kervitsky, Director of Marketing
contact@mydecineinc.com 

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com 

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

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Source: Mydecine Innovations Group Inc.

Released February 1, 2022

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Psilocybin works twice as well as nicotine patches!

Mydecine Secures Financing and Provides Company Update on Clinical Trials, Drug Development and Technology Initiatives

Dr. Matthew Johnson’s research found that 59% of nicotine-addicted patients remained abstinent from smoking for 12 months after receiving a single macrodose of psilocybin. Only 28% of patients on a nicotine patch remained abstinent for the same time period.

His other research shows that multiple psilocybin doses can have an 80% success rate!

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Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) Leader in Emerging Psychedelic-Assisted Psychotherapy Industry

Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) Leader in Emerging Psychedelic-Assisted Psychotherapy Industry

NEW YORK, Nov. 04, 2021 (GLOBE NEWSWIRE) — NetworkNewsAudio – Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) announces the availability of a broadcast titled, “Breaking the Habit: Psychedelic Stigma Fades as Research Points to Critical Use in Smoking Cessation and More.”

To hear the AudioPressRelease, please visit: The NetworkNewsAudio News Podcast

To view the full editorial, please visit: https://nnw.fm/8YBVv

A small study by Johns Hopkins University published in “Journal of Psychopharmacology” compared smokers trying to quit using cognitive behavioral therapy (CBT) plus varying doses of psilocybin to abstinence rates typically observed in smokers using other medications or CBT alone. The results showed 67% of the participants remained nicotine free at a 12-month follow-up, a substantial increase over success rates for other methods (typically 10% to 35%). …

Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) is an integral part of this landmark NIH-funded research led by Johns Hopkins, a three-year, multisite smoking cessation study being conducted in collaboration with University of Alabama at Birmingham and New York University. Mydecine will be supplying its lead drug candidate, MYCO-001 (99% pure psilocybin), for use in the clinical trials. The supply agreement, in the words of Mydecine CEO Josh Bartch, “not only offers a significant opportunity to further advance our drug development through safer and more viable results but demonstrates Mydecine’s leadership position in the emerging psychedelic-assisted psychotherapy industry.”

About Mydecine Innovations Group

Mydecine Innovations is a biotechnology and digital technology company developing innovative first- and second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug-development infrastructure. Mydecine was founded in 2020 on the guiding principle that there is a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The company’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way mental health disorders are viewed. Mydecine’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients.

For more information about the company, please visit www.Mydecine.com.

NOTE TO INVESTORS: The latest news and updates relating to MYCOF are available in the company’s newsroom at https://ibn.fm/MYCOF.

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Source: Mydecine Innovations Group Inc.

Released November 4, 2021

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Mydecine To Supply Lead Drug Candidate, MYCO-001, for Multi-Site NIDA Grant-Funded Smoking Cessation Study Lead by Dr. Matthew Johnson

Mydecine To Supply Lead Drug Candidate, MYCO-001, for Multi-Site NIDA Grant-Funded Smoking Cessation Study Lead by Dr. Matthew Johnson

Research to take place at Johns Hopkins, New York University and University of Alabama Birmingham

DENVER, Oct. 05, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a biopharmaceutical company focused on the treatment of mental health disorders and addiction, today announced that it plans to supply its lead drug candidate, MYCO-001, for a multi-site smoking cessation study being conducted at Johns Hopkins University (“JHU”), New York University and the University of Alabama Birmingham by leading drug and substance use researcher, Dr. Matthew Johnson. Dr. Johnson received a U01 grant from National Institute on Drug Abuse (NIDA) to fund this study, making it the first time in over 50 years that the U.S. government has funded a study of a psychedelic compound for therapeutics.

Mydecine, which exercises a five-year research agreement with JHU to study the impact of psychedelics on smoking cessation amongst other initiatives, announced earlier this September that it had partnered with Dr. Johnson to complete a seamless Phase 2/3 smoking cessation clinical trial for MYCO-001. Projected to launch in Q1 2022, the Phase 2/3 clinical trial will run concurrently with the newly announced multi-state study. The company believes both studies will serve to provide further supportive efficacy and safety data for MYCO-001.

Josh Bartch, CEO of Mydecine stated, “The NIDA’s decision to fund the continuation of Dr. Johnson’s smoking cessation study is a strong validator of medicines, such as our MYCO-001 formulation, for the treatment of smoking cessation. Previous clinical results by Dr. Johnson and his team at Hopkins have shown six-month abstinence rates as high as 80%, which is unheard of in the addiction space. NIDA ranked this study incredibly high, which further solidifies our approach to treat this deadly addiction.”

Bartch continued, “We are excited to support Dr. Johnson and his team in this concurrently running study which we believe will add a significant benefit to support our 2/3 seamless design. We have made significant progress advancing our MYCO-001 clinical trials for smoking cessation to date with JHU. The opportunity to play an integral role in this landmark study by supplying our lead drug candidate, not only offers a significant opportunity to further advance our drug development through safer and more viable results, but demonstrates Mydecine’s leadership position in the emerging psychedelic-assisted psychotherapy industry.”

“The incredibly promising clinical data that has been accumulated by the evolving psychedelic therapeutics industry to date makes these types of collaborations potentially a game-changer in smoking cessation,” said Mydecine CMO, Dr. Rakesh Jetly. “The U.S. government’s recognition of this valuable data and their support in advancing the development of psychedelic-based therapy to help create a more effective treatment option supports our mission to bring these needed drugs to the forefront of the market.”

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and addiction. Mydecine Innovations Group was founded in 2019 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we view mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter, and LinkedIn.

For more information, please contact:

Media Contacts
Anne Donohoe / Nick Opich
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1265 / 1-212-896-1206

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

Source: Mydecine Innovations Group Inc.

Released October 5, 2021

Posted on

Government-funded shroom trip?

Psilocybin Study for Tobacco Gets Federal Funding

After half a century, the US federal government has started funding psychedelic research again!

A researcher at Johns Hopkins University received a U01 grant from the National Institute on Drug Abuse (NIDA) to fund a multi-site study on psilocybin for tobacco addiction, which will take place at Johns Hopkins, New York University, and the University of Alabama at Birmingham.

The researcher, Dr. Matthew W. Johnson, noted that this is the first time a psychedelic study has received funding since the War on Drugs was declared in the 70s, marking a “new era in legitimacy of psychedelic science”.

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Mydecine Innovations Group Announces MYCO-001 Seamless Phase 2/3 Smoking Cessation Clinical Trial

Mydecine Innovations Group Announces MYCO-001 Seamless Phase 2/3 Smoking Cessation Clinical Trial

Dr. Matthew Johnson will lead research to look at the science and efficacy of MYCO-001 for the treatment of smoking cessation and nicotine dependence

DENVER, Sept. 07, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA), a biopharmaceutical company focused on the treatment of mental health and addiction, announced it has partnered with Principal Investigator Dr. Matthew Johnson of Johns Hopkins University on a study evaluating the administration of MYCO-001 with a structured smoking cessation treatment program in nicotine dependent individuals.

The planned placebo-controlled study, based with the Johns Hopkins psychedelic research group, will study the science and efficacy of MYCO-001 to treat nicotine dependence. Dr. Matthew Johnson, a globally recognized leader in this field who has published extensively on the science of psychedelics, has been contracted by Mydecine to complete this phase 2/3 clinical trial of his ongoing research and develop methodologies to better advance future-controlled studies and clinical trials of psychedelics. The proposed study is projected to launch in Q1 2022 and will be looking at primary endpoints of three and six months. This study could be completed as early as Q4 2022.

Combining two or more phases into one study is known as an operationally seamless clinical trial. Operationally, seamless clinical trial designs utilize results acquired throughout the trial to adjust the course of the study as data is collected. Analyses of the accumulating study data are performed at pre-planned time points within the study; therefore it could be possible to change the study dose, treatment duration, or study endpoints. This adaptive approach allows resources to be used more efficiently and can often be more informative and ethical than a traditional fixed design.

A 2014 Johns Hopkins University study published in the Journal of Psychopharmacology, showed an 80% abstinence rate at six months. Currently, the center is conducting a continuation on smoking cessation with a randomized comparative efficacy study involving 80 patients in which a transdermal nicotine patch and cognitive therapy treatment or psilocybin and cognitive therapy treatment are administered. Over half of the patients in the ongoing study have completed their 13-week program with compelling success rates that far exceed the 10% to 35% success rates for traditional smoking cessation therapies.

Mydecine CEO Josh Bartch stated, “Current clinical data coming out of Johns Hopkins on the ongoing smoking cessation study is showing 12-month efficacy rates significantly higher than today’s gold standard with drastically increased safety profiles. We have been diligently working with the teams at Hopkins, Applied Pharmaceutical Innovation, The Weinberg Group, and ethica CRO to design the planned study.” Bartch continues on to say, “We firmly believe in the high likelihood of receiving breakthrough therapy status on our MYCO-001 product for smoking cessation and look forward to updating the market soon on future developments.”

Tobacco, and its active ingredient nicotine, is one of the most highly addictive substances in the world, and one of the deadliest. According to the Centers for Disease Control (CDC) and Prevention, cigarette smoking is responsible for one out of every five deaths in the United States, roughly 480,000 people every year. Smoking is also directly associated in $1.4 trillion in health expenditures and productivity losses combined.

Approximately 14% of the U.S. population, 34.1 million Americans, currently smoke cigarettes.

  • 68% have stated they would like to quit smoking
  • 55% have made an attempt to quit
  • Approximately 7.5% are successful

In 2019, the global market for tobacco addiction was valued at $6 billion. By 2026, the market is expected to reach $64 billion, growing at a CAGR of 16.9%. Currently, the most popular form of tobacco addiction treatment is Nicotine Replacement Therapy (NRT), with various formulations available in transdermal patches, spray, gum, lozenges, and so on.

“As a physician who has worked with many patients struggling to quit highly addictive substances, I have seen firsthand the tremendous harm nicotine has on the body,” said Mydecine CMO Dr. Rakesh Jetly. “We are excited to be working alongside Johns Hopkins University toward safer and more effective treatments.”

Until it was recalled in July 2021, one of the most successful smoking cessations treatments was varenicline, or Chantix. Sales for Chantix reached $1.1B in 2020 despite the potential harmful side effects. Although a wide variety of treatments exist, tobacco addiction continues to remain largely untreated.

“We wholeheartedly believe the future success of psychedelic medicine is dependent on collaborative efforts between top-tier research institutions and private organizations to better understand the effectiveness of these drugs compared to current treatment options. The research of Dr. Johnson and his team at Johns Hopkins University has played a significant role in the renaissance of psychedelics and its growing acceptance within the scientific and medical communities. We are honored to begin working with them to advance this important study,” said Chief Science Officer of Mydecine, Rob Roscow. “Additionally, as Mydecine advances its own commercialized efforts to develop novel molecules and drug candidates like MYCO-001, the work of Dr. Johnson will inform as to how we can best build upon the academic success seen in this field and advance real world treatment options for the patients who desperately need them.”

Dr. Matthew W. Johnson, Ph.D., is a professor of psychiatry and behavioral sciences at Johns Hopkins University. He is one of the world’s most published scientists on the human effects of psychedelics and has conducted seminal research in the behavioral economics of drug use, addiction, and risk behavior. As principal Investigator, he developed and published the first research on psychedelic treatment of tobacco addiction in 2014. Dr. Johnson was the 2019 president of the Psychopharmacology and Substance Abuse Division of the American Psychological Association and is current president of the International Society for Research on Psychedelics, an organization he founded with colleagues.

About Mydecine Innovations Group

Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and addiction. Mydecine Innovations Group was founded in 2019 on the guiding principle that there is a significant unmet need and lack of innovations in the mental health and therapeutic treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we view mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands. For more information, please visit www.Mydecineinc.com.

For more information, please contact:

Media Contacts
Courtney Ryan
CRyan@LS2group.com
1- 515-770-4823

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:

Joshua Bartch, Chief Executive Officer contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the company’s profile on SEDAR at www.sedar.com or visit the company’s website at www.mydecine.com. This news release contains forward-looking information within the meaning of Canadian securities laws regarding the company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes”, or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, or “will” be taken, occur, or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the company to adequately protect and enforce its intellectual property, the company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale, and use of the company’s products. Although the company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated, or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the company does not assume any obligation to update or revise them to reflect new events or circumstances as required under applicable securities legislation.

Source: Mydecine Innovations Group Inc.

Released September 7, 2021