Monthly Archives: May 2022

CYB004 is one of Cybins CYBN proprietary second-generation psychedelics, developed to treat depression, anxiety, and substance abuse disorders. According to the company, the substance has recently shown positive preclinical data over DMT, the molecule from which it is derived.

Cybin has observed that the preclinical study showed promising results for CYB004 regarding bioavailability, duration of the effect, and the onset of the psychoactive effect.

When compared with oral DMT, Cybins proprietary substance showed an increase in bioavailability of almost 2000% (since orally administered DMT shows little to no bioavailability), and of 41% when compared to inhaled DMT. Regarding the duration of the effect, CYB004 lasted almost three times longer as intravenously administered DMT.

DMT has shown to be a promising and effective psychedelic for the treatment of mental health issues. However, known side effects like disorientation and anxiety and its mode of administration have historically hindered its use and availability. CYB004 via inhalation may solve these challenges and finally support a clinical path forward for this important therapeutic, commented Doug Drysdale, CEO of the company. Inhaled CYB004 is being developed to potentially overcome the limitations of IV DMT and become an important treatment option for anxiety disorders for patients and physicians.

The company plans to submit a regulatory filing for a pilot study in the second quarter of 2022, with the aim to initiate it in the following quarter.

CYB004 is administered through inhalation, and Cybin has applied for a patent for that delivery method.

This year, at the upcomingBenzinga Psychedelics Capital Conference, to be held onApril 19 at the Fontainebleau MiamiBeach Hotel in Florida, Doug Drysdale will share his vision and valuable insights about the burgeoning sector.

Photo: Courtesy ofLouis ReedonUnsplash

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Cybin's CYB0004 Shows Positive Preclinical Results Over ...

Witnesses say the 25-year-old woman fell down along the trail and refused help.

SNOHOMISH COUNTY, Wash A 25-year-old woman has been found dead near Wallace Falls in Snohomish County. Police suspect psychedelic mushrooms played a part.

Leigh Kuppler was out for a hike at the falls with her partner last Friday when they ran into a pair of young women.

At one point, she was standing there, and she fell straight back onto the ground, hitting her head on the rocks," said Kuppler.

According to Kuppler, the women appeared intoxicated but not drunk. One of the women had torn clothing and dirt on her face.

She hugged us and said, 'I hope you enjoy this trail, said Kuppler. "Then she hugged her friend. After that, she took a couple steps back and was standing looking at us, and she fell straight back hitting her head again."

Kuppler tried to help the hikers, but they refused.

Her friend was just saying that everything was fine and to leave them alone," said Kuppler.

Concerned for their safety, Kuppler called 911.

The last words I exchanged with her were, good luck, I hope everything is OK," said Kuppler.

The next morning, a search and rescue crew found 25-year-old Alisonstar Molaf of New Jersey dead near the Wallace River.

The Snohomish County Sheriff's Office said both women were "under the influence of mushrooms."

It really sits heavy with me knowing I was the last one to see her alive, and it just happened so quickly," said Kuppler.

The trail to Wallace Falls can be dangerous because there are cliffs along the way.

It isn't hard for people to get in trouble when they're sober. Experts said the odds of something bad happening increase exponentially under the influence of psychedelics.

In a dangerous environment, I think accidents are prone to happen," said University of Washington researcher Dr. Nathan Sackett.

Sackett believes psilocybin, the active ingredient in hallucinogenic mushrooms, is quite safe on its own.

Psychedelic mushrooms are growing in popularity with their decriminalization in Oregon, the trend of "microdosing" small amounts to increase creativity, and their promising use as a therapeutic for everything from depression to addiction.

However, mushrooms can also make people hallucinate, act impulsively and not think of any potential consequences for their actions.

This is a big concern of mine," explained Sackett. As psychedelics become culturally more normative, it's really important that people know they should do them in a controlled environment. Hopefully, one day, people won't have to hide in the woods to experience them."

The official cause of Molaf's death has not been determined by the Snohomish County Medical Examiner. Sheriff's department investigators announced her death does appear to be accidental.

For people intent on experimenting with mushrooms, or any psychedelic, Sackett advised people to be in a safe place with people they trust and to have a sober person on hand if things take a dangerous turn.

It really is frustrating, and it's hard to deal with because I wish I could've done more," said Kuppler. "I think we did the right thing, though, by calling someone who could help. You just don't know what's gonna happen."

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Psychedelics played role in Wallace Falls hiker's death ...

In recent years, dozens of newcompanies have begun to undertake the long and expensive process of developing psychedelics-based drugs for regulatory approval.

In turn, a handful of VC firms focused specifically on funding psychedelics businesses have stepped up to the plate, helping to spur studies around compounds like MDMA, psilocybin, and LSD for a plethora of illnesses.

But as drugs inch closer to approval by regulatory bodies like the Food and Drug Administration, they also become much more expensive to develop, since later-stage clinical trials often require larger numbers of participants, more trial sites, and longer trial lengths.

Enter mainstream healthcare VCs, who are dipping their toes into the still-nascent industry and have the deep pockets to support expensive late-stage clinical trials, which are crucial in order to get any new drug to market.

While a handful of high-net-worth individuals and tech investors have made investments in studying the use of psychedelics as medicine, the entry and sustained presence of mainstream healthcare VCs marks a new level of acceptance for the space, one that brands psychedelics as promising treatment for mental-health disorders in established biotech circles.

Insider scoured press releases and talked with healthcare analysts and psychedelics VCs in order to understand which mainstream healthcare VCs are leading the charge on turning psychedelics into regulated treatments.

One of the most high-profile healthcare VCs that has invested in psychedelics companies is Boston-based RA Capital. The firm, which has previously invested in companies including Novavax and Moderna, has funded at least three psychedelics-focused companies since 2020: GH Research, Cybin, and Delix Therapeutics.

All three companies are working to develop psychedelics-based compounds to treat mood disorders such as depression and anxiety.

According to CB Insights, RA Capital was one of the most active healthcare VCs in the second quarter of 2021. RA Capital did not respond to Insider's request for comment.

Other mainstream firms, like Catalio Capital and OrbiMed have made at least two investments into the space.

Catalio Capital was founded in 2020, when it spun out from Camden Partners Holdings to focus on expanding its investments in the biotech space. It has invested in biotech companies including Thrive Earlier Detection, Recursion, and Freenome. The firm backed the psychedelics companies Atai and Compass Pathways when the companies were private, and since their respective IPOs, Catalio has continued to hold positions.

New York-based OrbiMed, which has invested in over 80 life-sciences startupsincluding diagnostics giants Invitae and Guardant Health. The firm has backedAwakn and Cybin in the psychedelics space. Awakn is developing ketamine and MDMA for alcohol-use disorder while Cybin is working to develop compounds like psilocybin and DMT to treat anxiety, neuroinflammation, and other illnesses in early-stage trials.

A smaller healthcare VC firm, Connecticut-based Soleus Capital, has made investments into two psychedelics companies: Compass Pathways and Field Trip.

The vast majority of mainstream healthcare VCs that have made an investment into the psychedelics space have gone in on one name:GH Research.

Almost a dozen mainstream biotech investors, including Deerfield Management Company and Venrock Healthcare Capital Partners, have backed the firm since it was founded in 2018.

Dublin-based GH Research is developing a medicine for treatment-resistant depression that's based on a psychoactive compound called 5-MeO-DMT, found in the Sonoran Desert toad. Its lead compound, GH001, was tested in a phase-one and partial phase-two trial, which wrapped up in November 2021.

The company said it expects to submit clinical trial applications for a phase-two-B trial in the third quarter of 2022.

Connor Williams, an analyst at RTW Investments who covers GH Research and neurological diseases, told Insider that he believes his and other VCs' interest in GH Research is based on the fact that the company's compound didn't have the same "onerous requirements for patients" as the other psychedelics in development. Cowen analyst Ritu Baral added that the pedigree of the company's founders who have substantial biotech experience likely also helped catapult awareness among specialist investors so quickly.

Though the vast majority of mainstream VCs interested in psychedelics have only hedged their bets on GH Research, George Petrocheilos, a managing partner at Catalio, told Insider that he believes more mainstream investors are becoming interested in the space.

"I think it's already happening," Petrocheilos said, adding that he's received a lot of diligence calls and interest calls from mainstream investors who want to better understand the industry.

"They understand that it's a great opportunity," he said.

RTW's Williams agreed that more healthcare VCs may become interested in the space, especially as the science develops.

"If you continue to see strong data with novel compounds that are differentiated, then it could grow," he said. "If you see data get worse, then maybe not. So it's really about following the science."

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The Mainstream Healthcare VCs Dipping Their Toes Into Psychedelics - Business Insider

Psychedemia is a mix of psychedelic and academiameaning the integration of psychedelics into academiaand is a term coined by LSD research pioneer Humphry Osmond in 1957.

It has been used since 2012 as the title for a grassroots collaborative psychedelics conference organized to foster novel contributions to this burgeoning field, and to consider data from new research with an open mind.

The three-day psychedemia conference in 2012 was organized by the University of Pennsylvania, the Penn Medicine Neuroscience Center, the Perelman School of Medicine, the Graduate and Professional Student Assembly, the School of Arts and Sciences Student Government, and several other departments was a grand gesture ten years ago to not only raise the awareness of psychedelics but give the whole industry a shot in the arm.

It represented a sort of full-circle path of academia for psychedelics after academia abandoned psychedelics when Harvard University psychology professor Timothy Leary derailed the industry in the 60s after doing experiments with psilocybin and LSD that lacked scientific rigor.

Now academia is reclaiming psychedelics and putting more university brainpower into it than ever before.

The psychedemia conference is still going on, with the next one scheduled in August 2022, as a partnership with the newly founded Center for Psychedelic Drug Research and Education at Ohio State University. It will be presented on the campus.

But academia-inspired conferences and the founding of university-related psychedelics studies centers are just the tip of the iceberg in the huge rush by academia to embrace and better understand psychedelics.

Universities are creating masters degree level psychedelics classes, attracting world-class scientists to help find novel psychedelics therapeutics, and pushing to create a broader and deeper intellectual base for psychedelics study and research that is just gaining traction.

Heres a quick look at five developments of note among the reported 100-plus U.S. universities researching psychedelics:

Brian Pace, a scholar at Ohio State University who teaches psychedelics studies at the university, and is one of the organizers of the 2022 Psychedemia conference to be held at Ohio State, told Open Foundation, a Netherlands non-profit think tank, that the new-agey, cultish stuff they see around psychedelics now, with tuning your chakras and merging souls or whatever, is their fault. Thats an abdication of the responsibility to investigate interesting questions and to chase down data: to find out how things work, Pace said. So where we are now is a very timid and late re-entry to the subject, more so for education than research. Psychedelic research didnt end when the universities and governments abandoned it. It continued in the underground. The role of the university courses on psychedelics is to identify and evaluate high-quality information on the topic. We have a lot of catching up to do and I think that should be done with humility.

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LSD Is Back On Campus, But This Time It's Approved - Green Market Report

Consuming magic mushrooms (shrooms) and alcohol together can have unpredictable results. For this reason, doctors recommend against combining alcohol and recreational drugs such as shrooms.

Alcohol and shrooms interact because they can affect the brain in some of the same ways. Combining substances that act similarly intensifies the drugs effects, side effects, and potential risks.

Some people may notice that mixing alcohol and mushrooms can lessen the effect of each drug. However, it may also make it more difficult to think clearly.

Keep reading to learn more about the effects of mixing mushrooms and alcohol.

Shrooms are mushrooms that contain psilocybin, a natural hallucinogenic and psychoactive compound. They can cause hallucinations and an inability to tell the difference between fantasy and reality.

Although people usually use shrooms recreationally, they can have adverse effects. People may experience:

Alcohol affects the brain similarly to shrooms. Drinking too much alcohol can change a persons mood and behavior, and it can cause people to have trouble with memory and motor control.

Although doctors generally advise against combining substances, there is limited research showing the effects of shrooms and alcohol. This means most of the effects of mixing them come from peoples reported use.

Combining alcohol and shrooms can cause unpredictable results, but experts consider it a high-risk combination. It can cause headaches, panic attacks, and nausea. Drinking alcohol while taking shrooms can also increase a persons risk of a bad trip, which can include hallucinations and frightening emotions.

Some people report drinking alcohol to lower the effect of shrooms and feel less high. While they may decrease the effects of alcohol, there is limited research supporting this, and the effects can be unpredictable.

It is also unclear how much alcohol is safe in combination with shrooms. Overall, doctors do not recommend consuming alcohol while using other drugs.

Experts also advise avoiding polysubstance use, which means using more than one drug together or within a short time.

Interestingly, researchers suggest that psilocybin, the active drug in shrooms, may help people with alcohol addiction. An ongoing study is currently exploring, in a controlled setting, whether psilocybin can lower the number of heavy drinking days among people living with alcohol addiction.

The psilocybin in mushrooms may have mind-altering effects, and reality can appear distorted. Other effects of mushrooms include:

Psilocybin causes hallucinations because it acts on serotonin receptors in the brain and other parts of the body. Serotonin and psilocybin can both bind to serotonin receptors, so when psilocybin is in the body, it competes with serotonin to bind to them.

These receptors are responsible for controlling our emotions and moods. They also control behavior, learning memory, appetite, and other processes.

Other psychedelics include lysergic acid diethylamide (LSD), mescaline, and dimethyltryptamine (DMT).

When combining psychedelics such as LSD with alcohol, people may also notice that the effects of alcohol are lower than usual. However, like with shrooms, these results can be unpredictable.

Researchers are also studying the benefits of using psychedelics in people with alcohol use disorder (AUD). Another study showed that using psychedelics might lower a persons alcohol intake.

These study conditions do not reflect real-life use of alcohol and psychedelics. In controlled studies, the risk of unsafe behaviors and side effects from illicit drugs is low.

People should note that the United States classifies shrooms as an illegal drug.

With years of evidence from peoples reported use and modern scientific studies, experts confirm that shrooms have low toxicity. They also have a low risk of addiction.

However, people can overdose on shrooms. The side effects of an overdose can include:

Another consideration is the risk of accidentally taking a poisonous mushroom when using shrooms.

The effects of mixing mushrooms and alcohol are unpredictable and may vary from person to person. The following symptoms of alcohol poisoning require immediate medical attention:

People experiencing a bad trip, or a psychologically challenging drug experience, may want to contact a doctor. A bad trip can feel like a sudden and long-lasting side effect of a drug. This may occur when taking shrooms alone or with alcohol.

During a bad trip, people can put themselves or others at risk of harm. Some may have aggressive or violent behaviors. A person who feels concerned about their well-being and the safety of others when mixing mushrooms and alcohol should seek immediate medical attention.

The effects of mixing shrooms and alcohol are unpredictable. While some people may experience a lower effect of shrooms when mixing them with alcohol, this effect is unproven. Someone can experience a bad trip when mixing drugs.

If a person experiences concerning side effects after consuming shrooms and/or alcohol, they should seek medical attention.

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Mixing mushrooms and alcohol: What you need to know - Medical News Today

MIAMI, May 02, 2022 (GLOBE NEWSWIRE) -- Mycotopia Therapies Inc. (OTC Pink: TPIA) (the Company), a biopharma company focused on research, technology, and the development of medical psychedelics, announced today a partnership with Brussels-based PsychedelicsEUROPE. Mycotopia Therapies will collaborate with PsychedelicsEUROPE to accelerate its psychedelic research and develop new models of care under the regulatory framework for the medicinal use of psychedelics for mental health in the EU market.

PsychedelicsEUROPE has a team of seasoned public affairs specialists advocating for the establishment of an EU-wide regulatory framework that promotes medicinal use of psychedelic substances to the benefit of patient, while stimulating research under a safe and predictable environment. Europes commercial psychedelic healthcare ecosystem is growing rapidly as innovative research centers, NGOs, and private companies attract ideas, capital, and mainstream support. While the U.S. Food and Drug Administration and public health authorities in other countries have formalized policies on psychedelic medicine, the EU is still formulating its policies for psychedelic substances. PsychedelicsEUROPE strives to be a beacon of innovative mental health care models, while inspiring and accelerating the development of regulations that work for the patient through its relationships with medical professionals, academia, and private sector shareholders.

With ambitious regulatory initiatives, such as the Europes Beating Cancer Plan, or the Pharmaceutical Strategy for Europe, we need to make sure that more focus and funding will be dedicated to innovative mental health solutions, like medicinal use of psychedelics, explains Viktor Chvatal, the Secretary-General of PsychedelicsEUROPE. Mr. Chvatal continued, In Europe, our goal is to raise awareness about existing best practices in other countries amongst the EU policy makers and regulators to speed up the process.

Ben Kaplan, CEO of Mycotopia Therapies, said, We are grateful to be able to have a role in advancing psychedelic therapy across Europe in a way that is consistent with sustainability principles while ensuring patient accessibility. We believe this partnership with PsychedelicsEUROPE will provide numerous opportunities to transform innovation into real treatments for patients across the EU and beyond. With that in mind, we look forward to collaborating with the rich academic and biomedical science community in the EU, as well as its world-class talent, to advance our commercialization efforts on our psychedelic assets.

Mr. Kaplan added, Mycotopia Therapies is continuing to work toward completing the acquisition of botanical psilocybin pioneer, Ei.Ventures. The transaction is moving forward as planned, and we look forward to providing shareholders with additional updates in the very near future.

About Mycotopia Therapies

Mycotopia Therapies focuses on helping you heal and reclaim your life. Your journey of healing is an understanding of the causes and works to mental wellness through psychedelic enhanced psychotherapy, integrated with a professional team of mental wellness practitioners and cutting-edge technology. Psychedelic therapy is a holistic and spiritual approach providing healing and has shown successful treatment for many years. Additional information on Mycotopia Therapies can be found on the Companys website at: https://www.mycotopiatherapies.com.

About PsychedelicsEUROPE

PsychedelicsEUROPE is an innovative mental health association with a global reach, which brings together leading research centers, NGOs, and private companies. Based on scientific evidence, the association advocates for a regulatory EU framework that promotes state-of-the-art therapies, fosters cutting-edge research, and secures lasting solutions for patients. Additional information on PsychedelicsEUROPE can be found on the Companys website at: https://www.psychedelicseurope.org

About Ei. Ventures

Emotional Intelligence Ventures, a company dedicated to research and production of botanical psychedelics, announced a public stock offering using the Reg A+ Framework. Ei. Ventures main differentiator in the space is a self-imposed directive to work exclusively with non-synthetic, plant and fungi-based ingredients for both is psychedelic and non-psychedelic products. https://www.Ei.Ventures

Forward-Looking Statement DisclaimerThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words intends, may, will, plans, expects, anticipates, projects, predicts, estimates, aims, believes, hopes, potential or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Companys research, manufacturing and other development efforts; (ii) the Companys ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Companys products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Companys industry and introduction of competing products; (vi) the Companys ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading "Risk Factors" in 20/20 Global, Inc.s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC's website, http://www.sec.gov.

For Media and Investor Relations, please contact:

David L. Kugelman(866) 692-6847 Toll Free - U.S. & Canada(404) 281-8556 Mobile and WhatsAppEmail: dk@atlcp.comSkype: kugsusa

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Mycotopia Therapies Partners with Public Policy Specialist PsychedelicsEUROPE to Explore Opportunities in the European Market - GlobeNewswire