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TDR’s Top 5 Psychedelic Developments For The Week Of May 17

5. 83% of Canadians Report One Or More Symptoms of Depression, Many Turning To Substances To Cope Field Trip Health (CNSX: FTRP; OTCMKTS: FTRPF) released the findings of a survey that revealed how Canadians are feeling, how they are coping, and what…

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5. 83% of Canadians Report One Or More Symptoms of Depression, Many Turning To Substances To Cope

Field Trip Health (CNSX: FTRP; OTCMKTS: FTRPF) released the findings of a survey that revealed how Canadians are feeling, how they are coping, and what they are doing to feel better amidst the COVID-19 pandemic. After nearly 15 months of rolling global lock-downs due to the COVID-19 pandemic, the survey results show a nation in the depths of a mental health crisis.

So depressing in fact, in the last two weeks (prior to the survey), more than half of Canadians felt down, depressed, or hopeless (56%) and felt little interest or pleasure in doing things (59%), while nearly three-quarters felt tired or had little energy (72%). Furthermore, the survey also found that the lockdown is disproportionately affecting women and younger people.

4. New Study Suggests That Inflammation Is A Core Feature Of Depression

Clinical researchers have long since postulated what role, if any, inflammation may have in the development of depressive disorders in humans. According to an extensive new study, researchers have demonstrated that inflammation is a core feature of depression, rather than simply an ancillary side effect.

In the largest study of its kind, an review of 85,895 people in the United Kingdom reveals that a higher degree of inflammation in the body is linked with a higher risk of depression—possibly opening up alternative means of treating the condition. C-reactive protein (CRP)—a benchmark biomarker for inflammation in the body—was found in higher levels in depressed people compared to non-depressed people. CRP is a protein made by the liver and levels in the blood increase when there is a condition causing inflammation somewhere in the body.

While this study does not prove causation, it confirms the inextricable links between inflammation and depression which researchers have observed for a long time. This could result in researchers re-imagining the primary causes for depression and looking more closely into attenuating inflammatory responses as first-line treatments. MYND Life Sciences—which aims to go public next week—is focusing its primary psilocybin research on the inflammation-depression connection.. 

__________

Washington D.C. Has The Highest Incidence Of Substance Use Disorder Among The Adult Population In The United States

___________

3. Psychedelic Stocks Mostly Mixed As Sector Holding Pattern Continues

The biggest psychedelic stocks were mixed this week, with the performance of Horizon Psychedelic Stock Index ETF (5.98%) skewed by the negative market reaction to Seelos Therapeutics “positive” Proof-of-Concept study of SLS-002 (intranasal racemic ketamine). As of May 14, “PSYK” ETF held a 19.33% stake in the company, according to the most recent update on its holdings. The performance in PSYK belied positive weeks in the Nasdaq Junior Biotechnology Index (1.57%) and Nasdaq Biotechnology Ishares ETF (1.13%).

Collectively, the sector remains in what some may call a “holding pattern”. Many companies remain mired in lower-high, grinding type downtrends and/or consolidatory action as the summer dog days approach. The market is rewarding fits of individual and sector news, as we’ve seen recently with MindMed’s Nasdaq uplisting news and California’s bill to legalize psychedelic possession gain traction. However, every broad-based rally attempt since March has been thwarted, so our outlook remains defensive on new positions for the time being.

CompanyTickerPrice ($)Weekly Change (%)WoW Volume Trend Market Cap (s/o)
Compass PathwaysCMPS35.924.44US$1.47B
Mind MedicineMNMD3.436.19US$1.17B
Seelos TherapeuticsSEEL3.26-37.18US$256.2M
Cybin Inc.CYBN1.81-5.72C$268.0M
Field Trip HealthFTRP5.78-3.18C$243.7M
Numinus WellnessNUMI0.933.33C$186.8M
Revive TherapeuticsRVV0.5124.39C$152.3M
Mydecine InnovationsMYCO0.335flatC$79.5M

In the news…

Cybin Inc. announced that the Institutional Review Board at the University of the West Indies Hospital, in Jamaica has granted approval to commence the study of its sublingual psilocybin formulation (CYB001) in a Phase II clinical trial for patients suffering with Major Depressive Disorder. Commencement of the clinical trial is subject to final confirmation of study material specifications by Jamaica’s Ministry of Health.

Field Trip Health announced the appointment of former US Senate Majority Leader Tom Daschle as a Special Adviser to the company. Daschle is one of the most senior political figures—past or present—to align with the psychedelics industry, having been a major Democratic party power broker in the Clinton-Bush years.

Havn Life Sciences has entered into a definitive agreement to acquire clinical stage intellectual property from Bolt Therapeutics. The IP consists of a combination of BOL-148, which has demonstrated potential for treating cluster headaches in a human study, and a neuroprotectant believed to act in unison with BOL-148. Upon completion of the acquisition, Havn Life will seek Orphan Drug Designation, Fast Track, Breakthrough Therapy, and Accelerated Approval for the development of the new therapy.

MindMed announced he approval by the local Swiss ethics committee of the first clinical trial evaluating the acute effects of different doses of mescaline and the role of the serotonin 5-HT2A receptor in mescaline-induced altered states of consciousness. The study will be conducted at the University Hospital Basel Liechti Lab, in Basel, Switzerland, and is planned to start this month.

PharmaTher Holdings announced that the FDA has approved its Investigational New Drug application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.   PharmaTher expects to begin enrolling patients in the Phase 2 clinical trial in Q3-2021.

Revive Therapeutics entered into a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary oral psilocybin thin film strip for itss clinical and commercial initiatives to evaluate in mental illness, neurological and substance abuse disorders. The partnership will allow Revive to expedite its clinical and commercial ambitions with psilocybin as a pharmaceutical, globally.

Wake Network has completed the first fully-legal importation of psilocybin mushrooms into the United States, having secured all required permits from the U.S. Drug Enforcement Administration. The company recently received approval from the Ministry of Health and Wellness in Jamaica to conduct the world’s first Phase 2b psilocybin microdosing clinical trial for depression and anxiety.

2. MindMed Receives FDA Type C Meeting Response for Project Lucy Phase 2b Clinical Trial

MindMed (NASDAQ: MNMD) announces receipt of Type C Meeting Responses from FDA leading to the finalization of its clinical development approach for Project Lucy by selecting Generalized Anxiety Disorder as an initial indication. MindMed is on target to submit its Investigational New Drug (IND) application for Project Lucy in Q3 2021 and expects to launch its Phase 2b clinical trial shortly thereafter in Q4 2021.

As an extension of the positive pre-IND meeting held with the FDA in December 2020, MindMed sought further agreement from the FDA on the Company’s clinical approach for the development of LSD in the treatment of anxiety disorders. In line with positive FDA feedback, MindMed will pursue the treatment of Generalized Anxiety Disorder as its first indication. 

The clinical development program is scheduled to advance in late 2021 with the launch of Study MMED008, which is a Phase 2b dose-optimization study of LSD in approximately 200 patients diagnosed with Generalized Anxiety Disorder. This study, with clinical sites mainly in the United States, will assess improvements in anxiety symptoms following a single administration of LSD and will be the catalyst to select a final dose to be taken forward into Phase 3 pivotal clinical trials.

1. California Bill To Legalize Possession Of Psychedelics Heads To Senate Floor After Committee Action

After passing a big procedural barrier on Thursday, a bill to allow the possession of psychedelics in California will move to the Senate floor. This gave a noticeable boost to psychedelic stocks on the public markets.

The bill, introduced by Senator Scott Wiener (D), had already passed two legislative committees. However, in order to be included on the Senate floor schedule, it had to be approved by the Senate Appropriations Committee before a critical filing deadline. Fortunately, that’s exactly what happened, with the panel approved it in a 5-2 vote.

If passed, the bill would remove penalties for people 21 and older who possess or share a variety of psychedelics, including psilocybin mushrooms, DMT, ibogaine, LSD, and MDMA.

Psychedelic stocks across the spectrum spiked on the news, with PharmatherMind Medicine, Numinus Wellness and Revive Therapeutics recording double-digit percentage gains while most others experiencing high single-digit gains. Although price did not follow through to close the week—which makes sense given the pharmaceutical/psychotherapy focus of the sector—nonetheless bill passage would further normalize acceptance of psychedelic possession in society.

The post TDR’s Top 5 Psychedelic Developments For The Week Of May 17 appeared first on The Dales Report.

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The next pandemic? It’s already here for Earth’s wildlife

Bird flu is decimating species already threatened by climate change and habitat loss.

I am a conservation biologist who studies emerging infectious diseases. When people ask me what I think the next pandemic will be I often say that we are in the midst of one – it’s just afflicting a great many species more than ours.

I am referring to the highly pathogenic strain of avian influenza H5N1 (HPAI H5N1), otherwise known as bird flu, which has killed millions of birds and unknown numbers of mammals, particularly during the past three years.

This is the strain that emerged in domestic geese in China in 1997 and quickly jumped to humans in south-east Asia with a mortality rate of around 40-50%. My research group encountered the virus when it killed a mammal, an endangered Owston’s palm civet, in a captive breeding programme in Cuc Phuong National Park Vietnam in 2005.

How these animals caught bird flu was never confirmed. Their diet is mainly earthworms, so they had not been infected by eating diseased poultry like many captive tigers in the region.

This discovery prompted us to collate all confirmed reports of fatal infection with bird flu to assess just how broad a threat to wildlife this virus might pose.

This is how a newly discovered virus in Chinese poultry came to threaten so much of the world’s biodiversity.

H5N1 originated on a Chinese poultry farm in 1997. ChameleonsEye/Shutterstock

The first signs

Until December 2005, most confirmed infections had been found in a few zoos and rescue centres in Thailand and Cambodia. Our analysis in 2006 showed that nearly half (48%) of all the different groups of birds (known to taxonomists as “orders”) contained a species in which a fatal infection of bird flu had been reported. These 13 orders comprised 84% of all bird species.

We reasoned 20 years ago that the strains of H5N1 circulating were probably highly pathogenic to all bird orders. We also showed that the list of confirmed infected species included those that were globally threatened and that important habitats, such as Vietnam’s Mekong delta, lay close to reported poultry outbreaks.

Mammals known to be susceptible to bird flu during the early 2000s included primates, rodents, pigs and rabbits. Large carnivores such as Bengal tigers and clouded leopards were reported to have been killed, as well as domestic cats.

Our 2006 paper showed the ease with which this virus crossed species barriers and suggested it might one day produce a pandemic-scale threat to global biodiversity.

Unfortunately, our warnings were correct.

A roving sickness

Two decades on, bird flu is killing species from the high Arctic to mainland Antarctica.

In the past couple of years, bird flu has spread rapidly across Europe and infiltrated North and South America, killing millions of poultry and a variety of bird and mammal species. A recent paper found that 26 countries have reported at least 48 mammal species that have died from the virus since 2020, when the latest increase in reported infections started.

Not even the ocean is safe. Since 2020, 13 species of aquatic mammal have succumbed, including American sea lions, porpoises and dolphins, often dying in their thousands in South America. A wide range of scavenging and predatory mammals that live on land are now also confirmed to be susceptible, including mountain lions, lynx, brown, black and polar bears.

The UK alone has lost over 75% of its great skuas and seen a 25% decline in northern gannets. Recent declines in sandwich terns (35%) and common terns (42%) were also largely driven by the virus.

Scientists haven’t managed to completely sequence the virus in all affected species. Research and continuous surveillance could tell us how adaptable it ultimately becomes, and whether it can jump to even more species. We know it can already infect humans – one or more genetic mutations may make it more infectious.

At the crossroads

Between January 1 2003 and December 21 2023, 882 cases of human infection with the H5N1 virus were reported from 23 countries, of which 461 (52%) were fatal.

Of these fatal cases, more than half were in Vietnam, China, Cambodia and Laos. Poultry-to-human infections were first recorded in Cambodia in December 2003. Intermittent cases were reported until 2014, followed by a gap until 2023, yielding 41 deaths from 64 cases. The subtype of H5N1 virus responsible has been detected in poultry in Cambodia since 2014. In the early 2000s, the H5N1 virus circulating had a high human mortality rate, so it is worrying that we are now starting to see people dying after contact with poultry again.

It’s not just H5 subtypes of bird flu that concern humans. The H10N1 virus was originally isolated from wild birds in South Korea, but has also been reported in samples from China and Mongolia.

Recent research found that these particular virus subtypes may be able to jump to humans after they were found to be pathogenic in laboratory mice and ferrets. The first person who was confirmed to be infected with H10N5 died in China on January 27 2024, but this patient was also suffering from seasonal flu (H3N2). They had been exposed to live poultry which also tested positive for H10N5.

Species already threatened with extinction are among those which have died due to bird flu in the past three years. The first deaths from the virus in mainland Antarctica have just been confirmed in skuas, highlighting a looming threat to penguin colonies whose eggs and chicks skuas prey on. Humboldt penguins have already been killed by the virus in Chile.

A colony of king penguins.
Remote penguin colonies are already threatened by climate change. AndreAnita/Shutterstock

How can we stem this tsunami of H5N1 and other avian influenzas? Completely overhaul poultry production on a global scale. Make farms self-sufficient in rearing eggs and chicks instead of exporting them internationally. The trend towards megafarms containing over a million birds must be stopped in its tracks.

To prevent the worst outcomes for this virus, we must revisit its primary source: the incubator of intensive poultry farms.

Diana Bell does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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A major cruise line is testing a monthly subscription service

The Cruise Scarlet Summer Season Pass was designed with remote workers in mind.

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While going on a cruise once meant disconnecting from the world when between ports because any WiFi available aboard was glitchy and expensive, advances in technology over the last decade have enabled millions to not only stay in touch with home but even work remotely.

With such remote workers and digital nomads in mind, Virgin Voyages has designed a monthly pass that gives those who want to work from the seas a WFH setup on its Scarlet Lady ship — while the latter acronym usually means "work from home," the cruise line is advertising as "work from the helm.”

Related: Royal Caribbean shares a warning with passengers

"Inspired by Richard Branson's belief and track record that brilliant work is best paired with a hearty dose of fun, we're welcoming Sailors on board Scarlet Lady for a full month to help them achieve that perfect work-life balance," Virgin Voyages said in announcing its new promotion. "Take a vacation away from your monotonous work-from-home set up (sorry, but…not sorry) and start taking calls from your private balcony overlooking the Mediterranean sea."

A man looks through his phone while sitting in a hot tub on a cruise ship.

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This is how much it'll cost you to work from a cruise ship for a month

While the single most important feature for successful work at sea — WiFi — is already available for free on Virgin cruises, the new Scarlet Summer Season Pass includes a faster connection, a $10 daily coffee credit, access to a private rooftop, and other member-only areas as well as wash and fold laundry service that Virgin advertises as a perk that will allow one to concentrate on work

More Travel:

The pass starts at $9,990 for a two-guest cabin and is available for four monthlong cruises departing in June, July, August, and September — each departs from ports such as Barcelona, Marseille, and Palma de Mallorca and spends four weeks touring around the Mediterranean.

Longer cruises are becoming more common, here's why

The new pass is essentially a version of an upgraded cruise package with additional perks but is specifically tailored to those who plan on working from the ship as an opportunity to market to them.

"Stay connected to your work with the fastest at-sea internet in the biz when you want and log-off to let the exquisite landscape of the Mediterranean inspire you when you need," reads the promotional material for the pass.

Amid the rise of remote work post-pandemic, cruise lines have been seeing growing interest in longer journeys in which many of the passengers not just vacation in the traditional sense but work from a mobile office.

In 2023, Turkish cruise line operator Miray even started selling cabins on a three-year tour around the world but the endeavor hit the rocks after one of the engineers declared the MV Gemini ship the company planned to use for the journey "unseaworthy" and the cruise ship line dealt with a PR scandal that ultimately sank the project before it could take off.

While three years at sea would have set a record as the longest cruise journey on the market, companies such as Royal Caribbean  (RCL) (both with its namesake brand and its Celebrity Cruises line) have been offering increasingly long cruises that serve as many people’s temporary homes and cross through multiple continents.

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As the pandemic turns four, here’s what we need to do for a healthier future

On the fourth anniversary of the pandemic, a public health researcher offers four principles for a healthier future.

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John Gomez/Shutterstock

Anniversaries are usually festive occasions, marked by celebration and joy. But there’ll be no popping of corks for this one.

March 11 2024 marks four years since the World Health Organization (WHO) declared COVID-19 a pandemic.

Although no longer officially a public health emergency of international concern, the pandemic is still with us, and the virus is still causing serious harm.

Here are three priorities – three Cs – for a healthier future.

Clear guidance

Over the past four years, one of the biggest challenges people faced when trying to follow COVID rules was understanding them.

From a behavioural science perspective, one of the major themes of the last four years has been whether guidance was clear enough or whether people were receiving too many different and confusing messages – something colleagues and I called “alert fatigue”.

With colleagues, I conducted an evidence review of communication during COVID and found that the lack of clarity, as well as a lack of trust in those setting rules, were key barriers to adherence to measures like social distancing.

In future, whether it’s another COVID wave, or another virus or public health emergency, clear communication by trustworthy messengers is going to be key.

Combat complacency

As Maria van Kerkove, COVID technical lead for WHO, puts it there is no acceptable level of death from COVID. COVID complacency is setting in as we have moved out of the emergency phase of the pandemic. But is still much work to be done.

First, we still need to understand this virus better. Four years is not a long time to understand the longer-term effects of COVID. For example, evidence on how the virus affects the brain and cognitive functioning is in its infancy.

The extent, severity and possible treatment of long COVID is another priority that must not be forgotten – not least because it is still causing a lot of long-term sickness and absence.

Culture change

During the pandemic’s first few years, there was a question over how many of our new habits, from elbow bumping (remember that?) to remote working, were here to stay.

Turns out old habits die hard – and in most cases that’s not a bad thing – after all handshaking and hugging can be good for our health.

But there is some pandemic behaviour we could have kept, under certain conditions. I’m pretty sure most people don’t wear masks when they have respiratory symptoms, even though some health authorities, such as the NHS, recommend it.

Masks could still be thought of like umbrellas: we keep one handy for when we need it, for example, when visiting vulnerable people, especially during times when there’s a spike in COVID.

If masks hadn’t been so politicised as a symbol of conformity and oppression so early in the pandemic, then we might arguably have seen people in more countries adopting the behaviour in parts of east Asia, where people continue to wear masks or face coverings when they are sick to avoid spreading it to others.

Although the pandemic led to the growth of remote or hybrid working, presenteeism – going to work when sick – is still a major issue.

Encouraging parents to send children to school when they are unwell is unlikely to help public health, or attendance for that matter. For instance, although one child might recover quickly from a given virus, other children who might catch it from them might be ill for days.

Similarly, a culture of presenteeism that pressures workers to come in when ill is likely to backfire later on, helping infectious disease spread in workplaces.

At the most fundamental level, we need to do more to create a culture of equality. Some groups, especially the most economically deprived, fared much worse than others during the pandemic. Health inequalities have widened as a result. With ongoing pandemic impacts, for example, long COVID rates, also disproportionately affecting those from disadvantaged groups, health inequalities are likely to persist without significant action to address them.

Vaccine inequity is still a problem globally. At a national level, in some wealthier countries like the UK, those from more deprived backgrounds are going to be less able to afford private vaccines.

We may be out of the emergency phase of COVID, but the pandemic is not yet over. As we reflect on the past four years, working to provide clearer public health communication, avoiding COVID complacency and reducing health inequalities are all things that can help prepare for any future waves or, indeed, pandemics.

Simon Nicholas Williams has received funding from Senedd Cymru, Public Health Wales and the Wales Covid Evidence Centre for research on COVID-19, and has consulted for the World Health Organization. However, this article reflects the views of the author only, in his academic capacity at Swansea University, and no funding or organizational bodies were involved in the writing or content of this article.

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