Delix Therapeutics, a private Boston-based company, is partnering with The National Institute on Drug Abuse (NIDA) to develop a treatment for substance abuse. The partnership will evaluate Delix’s non-hallucinogenic formulation of ibogaine, which has already shown promise of reducing alcohol- and heroin-seeking behavior.
Clearmind Medicine’s (CMND) proprietary compound could treat alcohol addiction, but that’s not all. It is now being evaluated to treat other addictive behaviours such as compulsive consumption of food, television, technology, shopping, gambling, and even sex.
A study discovered that psilocybin can reduce the odds of alcohol relapse!
How does it work? Alcohol reduces a protein in the brain called mGluR2. In a rat model, researchers found that the more protein lost, the more alcohol the rats craved, creating an addictive cycle.
Psilocybin was able to restore protein levels, thus decreasing relapses.
A new study found that people who used psychedelics within the past six months were 55% less likely to use opioids daily.
Comparative CYB003 pre-clinical data on the Company’s deuterated psilocybin analog may have wide-reaching implications for the treatment of Major Depressive Disorder (“MDD”) and Alcohol Use Disorder (“AUD”) with less patient variability, faster onset of action, shorter duration of effect and improved brain penetration
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today announced positive CYB003 pre-clinical findings that demonstrate multiple advantages for its newly developed novel deuterated psilocybin analog over oral psilocybin for the treatment of mental health.
“Multiple academic studies have shown that psilocybin may have the potential to revolutionize mental healthcare, but few companies have addressed the well-known limitations and side effects of oral psilocybin. Cybin has always strived to develop safer and more effective therapies for patients, which has guided our multiple psilocybin programs: CYB001, CYB002, and CYB003,” said Doug Drysdale, Cybin’s Chief Executive Officer.
Academic research performed at New York University and John Hopkins University has indicated oral psilocybin to be efficacious in the treatment of mental health disorders, especially MDD, but with significant limitations, specifically: slow onset of action, extended duration of effect, and a variability in response among patients. The Company’s CYB001 and CYB002 programs studied proprietary formulations, while the Company’s CYB003 program explored proprietary analogs with the goal to retain the benefits and address the challenges. Today the Company is pleased to announce that its proprietary molecular advancements offer positive benefits and address the challenges and limitations of oral psilocybin.
In multi-species pre-clinical studies, the Company’s deuterated psilocybin analog from its CYB003 program demonstrates:
The deuterated psilocybin analog in CYB003 has the potential to reduce time and resource burden on patients, providers and payers, and possibly improving scalability and accessibility from the following conclusions:
“While we are all encouraged by the benefits of psilocybin, we need to transparently and openly discuss its limitations if we are to translate psychedelics to therapeutics for patients in need. The majority of current clinical studies are based on psilocybin. We have taken the necessary steps to potentially unlock the powerful benefits of psychedelics and engineer a superior molecule as demonstrated by the data. We are on a mission to make ethical, safe scientific progress to advance the care and treatment of mental health patients. Our goal has always been to be a leader in creating the best therapy for patients, today we move one step closer,” said Doug Drysdale, Cybin’s Chief Executive Officer.
The presentation showcasing the Company’s data will be made available on the Cybin website within 24 hours.
As a reminder, the Company welcomes all media and analysts that are attending the Wonderland Conference in Miami to physically join its presentation today at 8:30am EDT.
Physical address for attendees:
Physical event is for media attendees and analysts only. To RSVP, please email info@cybin.com.
The Adrienne Arsht Center for the Performing Arts
Next Generation Green Room
Arts of Miami-Dade County, Inc.
1300 Biscayne Blvd. Miami, FL 33132
The Company welcomes shareholders and the general public to virtually join its presentation today at 8:30am EDT.
Virtual Webcast:
Virtual event is open to shareholders and the general public.
Topic: Cybin Research & Development Press Conference
Location: Wonderland Conference, Miami, FL
Time: Nov 8, 2021 08:30 AM Eastern Time (US and Canada)
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About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally-recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in the USA, UK and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the potential benefits of the Company’s multiple psilocybin program CYB001, CYB002, and CYB003, the potential benefits of psilocybin, and the development of the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens in order to advance the care and treatment of mental health patients and to address a multitude of mental health issues.
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended June 30, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.
Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.
Investor & Media Contacts:
Leah Gibson
Vice President Investor Relations
Cybin Inc.
leah@cybin.com
Tim Regan/Scott Eckstein
KCSA Strategic Communications
cybin@kcsa.com
Lisa M. Wilson
In-Site Communications, Inc.
lwilson@insitecony.com
Source: Cybin Inc.
TORONTO, CANADA, November 4, 2021 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat addiction, announced today that the ‘Ketamine in the Reduction of Alcoholic Relapse’ (KARE) psychotherapy intervention study, which was the first controlled study in the world to investigate ketamine-assisted psychotherapy, will be published in the American Journal of Psychiatry later this year. The study was conducted by University of Exeter (UoE) and led by Prof. Celia Morgan, Professor of Psychopharmacology at UoE and Awakn’s Head of Ketamine-assisted psychotherapy for addiction. Awkan has acquired the rights to this research.
The findings, which will be shared in detail in the journal, are a very exciting step forward in the treatment of alcohol use disorder and for the wider psychedelic industry in general. The phase II a/b trial had four groups, ketamine with and without therapy, and placebo administered with and without therapy.
Professor Morgan commented “We are delighted that the findings are to be published in the American Journal of Psychiatry. This new approach looks set to revolutionise the treatment of alcohol use disorder. We are excited to partner with Awakn for the next steps in the journey of ketamine-assisted therapy into a licensed treatment for this group of patients with limited treatment options.”
With ketamine already a licenced medicine, the phase II a/b results allow Awakn to deliver the KARE treatment in its clinics in the UK and Europe immediately and through its licencing partnerships outside of these territories. The University of Exeter and Awakn are investigating how best to move this research forward to a pivotal phase III trial, which ultimately would allow it to be delivered ‘on label’, meaning it could be adopted by public health systems and covered by insurers.
Following the study, Dr. Morgan’s research team also interviewed participants in the trial and published an analysis of their experiences in the journal Frontiers in Psychiatry entitled, “This Is Something That Changed My Life: A Qualitative Study of Patients’ Experiences.” A brief selection of quotes from the paper below, show the life-changing effect the treatment had on them and crucially how it changed their relationship with alcohol.
It helped family wise, relationship wise, in every, every single avenue of my life, It’s changed it.
I wouldn’t be here now if it wasn’t for it. I can definitely say that.
I feel I have much less desire to drink now than I used to. And I think what it is, I actually, I think I enjoy it less now”
“I think before the trial all my life was sort of focused around alcohol. I was either drinking it at home or selling it to students or working in an event where there was alcohol, the alcohol was a focus of it. So it was sort of everything and then afterwards, it just sort of stopped.
Chief Executive Officer of Awakn, Anthony Tennyson commented; “This is a very exciting moment for ketamine-assisted psychotherapy. For so many people who are suffering from alcohol addiction, for whom the current treatments just aren’t working, a successful phase II a/b trial and a unified ambition to progress this forward to a pivotal trial, gives real hope to those seeking a better and healthier future.”
About Awakn Life Sciences Corp.
Awakn Life Sciences is a biotechnology company with clinical operations, developing and delivering psychedelic therapeutics (medicines and therapies) to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat addiction. Awakn will deliver these evidence backed psychedelic therapies in clinics in the UK and Europe and through licensing partnerships globally.
www.awaknlifesciences.com | Twitter | LinkedIn | Facebook
Notice Regarding Forward Looking Information
This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.
Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.
This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
Investor Enquiries:
KCSA Strategic Communications
Valter Pinto / Tim Regan
Phone: +1 (212) 896-1254
Awakn@KCSA.com
Media Enquiries:
America and Canada: KCSA Strategic Communications
Anne Donohoe
Adonohoe@KCSA.com
Rest of World:
ROAD Communications
Paul Jarman / Anna Ramsey
Awakn@roadcommunications.co.uk
This psychedelic makes you feel drunk. Could it be used to treat alcoholism?
5-Methoxy-2-aminoindane (MEAI) is a synthetic molecule that simulates the euphoric feeling of alcohol while reducing the desire to drink.
Pre-clinical studies conducted by Clearmind Medicine Inc. (CMND) show promising evidence that MEAI could treat alcohol use disorder (AUD) and binge drinking. Clinical trials expected to begin in the second half of 2022.
The company just signed a development and supply agreement with Aragen Life Sciences to manufacture the molecule.
These companies are joining forces to develop unique treatments for a range of debilitating conditions.
Agtech Global International Inc. (AGGL) and KRTL Biotech Inc. are partnering to develop CBD and psilocybin-based medicines to treat conditions like ADHD, pain from cancer, autism, PTSD, depression, and addiction.
The agreement will leverage KRTL’s team of researchers in the US and Korea, where they have already received the Korean equivalent of FDA approval to study the compounds.
Several other companies are supporting the research project including Here To Serve Holding Corp. (HTSC) and Pervasip Corp. (PVSP).
TORONTO, September 23, 2021 – Awakn Life Sciences Corp. (Awakn), (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) a biotechnology company developing and delivering psychedelic therapeutics to treat addiction, announced today that it has acquired the exclusive rights to the data from the phase IIa Bristol Imperial MDMA in Alcoholism Study (BIMA) from Imperial College London, which has one of the world’s leading psychedelics research centers.
BIMA was an Open-label safety, tolerability and proof-of-concept study to investigate the role of MDMA-Assisted Psychotherapy in treating patients with alcohol use disorder (AUD). It was the first published study assessing MDMA-Assisted Psychotherapy as a treatment for addiction. The results which were published in February 2021, indicated that MDMA has the potential to be more effective at treating AUD. With a 20% relapse rate within the first nine months, compared to 75% relapse rate with traditional treatments.
This data will assist Awakn’s progress by enabling a better design and more efficient execution of its clinical program. Awakn will now be able to accelerate its clinical research into a phase IIb randomized controlled trial (RCT) in the U.K. This is part of its strategy to secure marketing authorization for MDMA to treat AUD in both the U.K. and the European Union, a 400 million person territory.
“Drinking behavior outcomes from the BIMA phase IIa study that Awakn just acquired indicates that MDMA has the potential to be more effective at treating AUD, with only a 20% relapse rate within the first nine months. This compares very favourably with the current best available traditional treatments for patients’ post-detox with AUD” said Dr. Ben Sessa, Chief Medical Officer of Awakn and the principal investigator of the BIMA study.
He continued, “This data acquisition is an important step along Awakn’s path to providing lifesaving MDMA treatment to the millions of people currently suffering with AUD, offering better outcomes without the exorbitant rates of relapse.”
AUD is a serious and currently poorly treated disorder, affecting 5% of the global adult population. Treatment of AUD rates are low at 16%.
About Awakn Life Sciences Corp.
Awakn Life Sciences is a biotechnology company with clinical operations, developing and delivering psychedelic therapeutics (drugs and therapies to be used in combination) to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat addiction. Awakn will also deliver evidence backed psychedelic therapies for addiction in clinics in the U.K. and Europe and through licensing partnerships globally.
www.awaknlifesciences.com | Twitter | LinkedIn | Facebook
About Imperial College London
Imperial College London is one of the world’s leading universities. The College’s 20,000 students and 8,000 staff are working to solve to the biggest challenges in science, medicine, engineering, and business.
Imperial is the world’s fifth most international university, according to Times Higher Education, with academic ties to more than 150 countries. Reuters named the College as the UK’s most innovative university because of its exceptional entrepreneurial culture and ties to industry.
Imperial staff, students and alumni are working round-the-clock to combat COVID-19. Imperial has nearly two thousand key workers, and is at the forefront of coronavirus epidemiology, virology, vaccine development and diagnostics. More than one thousand Imperial staff and students are volunteering to support the NHS.
http://www.imperial.ac.uk/
Notice Regarding Forward Looking Information
This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.
Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.
This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
Investor Enquiries:
KCSA Strategic Communications
Valter Pinto / Tim Regan
Phone: +1 (212) 896-1254
Awakn@KCSA.com
Media Enquiries:
America and Canada: KCSA Strategic Communications
Anne Donohoe
Adonohoe@KCSA.com
Rest of World: ROAD Communications
Paul Jarman / Anna Ramsey
Awakn@roadcommunications.co.uk
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”.
