Daily Archives: June 6, 2020

Once dismissed as a "party drug" for its hallucinogenic effects, ketamine is emerging as a novel alternative treatment for depression

Psychedelic medicine is having a moment.

Last year, the US Food and Drug Administration (FDA) approved esketamine to treat depression, making it the first-ever psychedelic drug to receive the regulatory green light in the US, withUK authorities also givingtheir approval for the ketamine-like druga few months later.

MDMA, commonly known as ecstasymeanwhile,has been given breakthrough therapy designation by the US regulatorfor post-traumatic stress disorder (PTSD). Against this backdrop, a flourishing new sub-sector of the life sciences industry is emerging.

READ:MindMed launches drug development program Project Lucy to treat anxiety disorders with LSD

For most, psychedelic drugs conjure up images of the 1960's, hippies tripping out on LSD or magic mushrooms. However, early studies are finding that psilocybin the active agent in magic mushrooms could treat addiction, depression, anxiety and mental health conditions like post-traumatic stress disorder (PTSD).

Similarly, cancer patients with painful anxiety over their illness have found more peaceful acceptance after participating in a study that involved intensive therapy and being given a drug that was once a symbol of the 60's counterculture.

While there are many parallels with the development of the cannabis industry, the trailblazers in the field of psychedelics are keen to stress the differences, particularly with reference to the recreational element of the former.

Psychedelics werent born of the counterculture. They were killed by it, says a report by investment bank , authored by Tania Gonsalves and Scott McFarland, which provides some of the first in-depth analysis of the sector.

Once dismissed as a "party drug" for its hallucinogenic effects, ketamine is emerging as a novel alternative treatment for depression. The approval ofs () nasal spray antidepressant that is chemically similar to often-abused ketamine, shines a light on New York-based ()which is advancing its own medication for depression.

Wall Street is bullish that Seelos SLS-002 intranasal ketamine depression drug under development is safe and will reach millions of patients with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) at risk of committing suicide.

The market for our SLS-002 depression drug is very large as more than 900,000 people were admitted to the ER for suicidality even though no effective drug treatment exists, Seelos Therapeutics CEO Raj Mehra told Proactive.

In November last year, the FDA granted SLS-002fast track designation for development of the drug as a treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients withmajor depressive disorder (MDD).

Seelos has also saidit is on track to release additional safety data on the Phase I studies of SLS-002 in the second quarter of 2020.

The psychedelics industry itself is big enough to pique the interest of Big Pharma, with Canaccord Genuity estimating the total market size for all indications under investigation to be as much as $100 billion. However, it is still start-ups and innovators which are setting the pace.

Mind Medicine (MindMed) Inc (NEO:MMED) () recentlylaunched Project Lucy, a commercial drug development program for the treatment of anxiety disorders. The Reno-based company said it intends to initiate a Phase 2b human efficacy trial that will focus on experiential doses of lysergic acid diethylamide (LSD) administered by a therapist.

MindMed noted that this is the first experiential, psychedelic-assisted therapy to be added to its drug development pipeline.

With the launch of Project Lucy, the company said it is now preparing a total of three Phase 2 commercial drug trials based on psychedelic-inspired medicines, making it one of the most advanced and largest drug development pipelines in the psychedelics industry.

MindMed cofounder and co-CEO JR Rahn, a former Uber employee and Y-Combinator alumnus, believes America was on track to face a mental health crisis before the coronavirus (COVID-19) outbreak, and self-isolation, social distancing, and job losses are exacerbating the problem.

I went through the Y-Combinator program from where companies like and Dropbox developed and I was looking at my friends companies that were going to put a lot of people out of work, Rahn told Proactive.

Ultimately, what I saw was that addiction and mental health problems were going to skyrocket in America. These problems were already large, but they were going to get bigger in time. Thats all been fast-forwarded now. COVID-19 and the lockdown in terms of isolation just made these problems bigger.

MindMed is making a run at curbing opioid abuse, based on 18-MC, a proprietary non-hallucinogenic molecule derivative of psychedelic ibogaine. Ibogaine comes from iboga, a West African plant whose yellowish root bark induces powerful psychedelic experiences. It has its genesis in healing ceremonies among various African communities.

Among other players, Vancouver-based Champignon Brands Inc () (OTCMKTS:SHRMFF) is planning to open at least five ketamine clinics in North America by the end of 2020. It recentlyclosed the acquisition of AltMed Capital Corp, a Canadian ketamine clinic operator with strong research and development projects.

Empower Clinics Inc () (OTCQB:EPWCF), the CBD product producer and wellness clinic operator, is also leveraging its existing clinic network, which boasts some 165,000 patients and a robust team of physicians, to focus on psilocybin research and psychedelics therapy in the treatment of mental health issues.

Taking the active ingredients of psychedelics and clinically proving their efficacy offers hope for those with post-traumatic stress disorder, alcoholism, anxiety, deep-seated depression and addiction.

Psychedelics have shown promising efficacy across a broad range of both mental and substance abuse disorders, the analysts at Canaccord said in their research note. Together, the targeted indications affect over one-billion people globally.

Your need-to-know guide to psychedelics:

Psilocybin

Found in over 200 species of mushrooms.

Potential uses: Depression, anxiety, addiction, OCD (obsessive-compulsive disorder), anorexia, obesity, cluster headaches, Alzheimers disease.

Lysergic acid diethylamide (LSD)

Chemically combined lysergic acid and diethylamide.

Potential uses: Cluster headaches, depression, anxiety, pain syndromes, alcoholism, ADHD (attention deficit hyperactivity disorder)

Ibogaine

Found in the root bark of a West African shrub.

Potential uses: Alcoholism, addiction and smoking cessation.

Methylenedioxymethamphetamine

A popular club drug thats sold in pills (ecstasy) or as a powder (MDMA)

Potential uses: PTSD, anxiety and alcoholism.

Ketamine

Used for starting and maintaining anaesthesia

Potential uses: Treatment-resistant depression PTSD, anxiety, alcoholism, pain syndromes and chronic fatigue syndrome.

US companies to watch:

Codebase Ventures Inc() () (FSE:C5B): Focused on investing in the psychedelic healthcare sector through subsidiaryTitan Shrooms and Psychedelics Inc

Back of the Yards Algae Sciences (Private): Mycelial and plant entheogen therapeutics for major mental health challenges including PTSD.

(Private): Developing cannabinoids and tryptamine-based compounds (psilocybin and psilocin) for neuroscience.

Champignon Brands (OTCMKTS:SHRMF): Focused on using psilocybin to treat mental health disorders.

Empower Clinics (OTCQB:EPWCF): US-focused wellness clinic operator getting into psychedelic treatment.

Mind Medicine (MindMed) (OTCQB:MEDF): Neuro-pharmaceutical company that discovers, develops and deploys psychedelics.

(): An ecommerce retailer of CBD products in Europe and the US that recently entered the psychedelics market.

NewLeaf Brands (CSE:NLB): Recently agreed to acquire Colorado-based Mydecine Group for $1.2mln, a mycology company.

Orthogonal Thinker (Private): A holding company focused on health and well-being through clean label, whole plant products, including psychoactive compounds.

Psybio Therapeutics (Private): Developing biosynthetic psychoactive compounds.

PsyGen (Private): A GMP-grade manufacturer of pharmaceutical psychedelic drug products for clinical research and therapeutic applications.

(OTCPINK:RVVTF): Life sciences company with a pharmaceutical IP portfolio that utilizes Bucillamine,psychedelicsand cannabis to focus on rare inflammatory areas such as gout, lung inflammation, liver disease, ischemia and depression

Seelos Therapeutics (): A clinical-stage biopharmaceutical company focused on CNS and rare disorders. It is advancing multiple programs through clinical trials.

Silo Wellness (Private): A vertically integrated recreational psilocybin mushrooms company.

Tabula Rasa Ventures (Private): A VC investing in legalized psychedelics.

WAKE (Private): Fungi and plant-based medicine

Contact Angela at [emailprotected]

Follow her on Twitter @AHarmantas

Uttara Choudhury also contributed to this article

Read the original post:

Companies are starting to bet big on psychedelic drugs to treat US mental health epidemic - Proactive Investors USA & Canada

Patriot Ledger Staff

ThursdayJun4,2020at12:01PM

LAUGH

Wild ride: The documentary "Have a Good Trip" is a star-studded exploration of psychedelics. It features beloved comedians and musicians Sting, Nick Offerman, Sarah Silverman, Paul Scheer, Weymouth native Rob Corddry, A$AP Rocky, Rosie Perez, Adam Scott, the Grateful Dead, Natasha Lyonne and Ben Stiller breaking down all things magic mushrooms in a variety of interviews and animated sequences illustrating their experiences on psychedelics. Available to stream on Netlfix

READ

Beach book: "Big Summer," Jennifer Weiner's big summer book, is a hugely entertaining mashup of a beach read/murder mystery/rich-people's-lives-porn/romance. It doesn't make a lot of sense, but it's sprawling and fun, so read and enjoy and just don't try to think about it too much. You get glimpses into high fashion and pricey beach homes and rich lifestyles, and you get to watch a fake-it-till-you-make-it insecure protagonist slowly learn how to stop faking it and actually make it.

RENT

Sweet gem: One worthy rental features the final screen performance of the recently departed legend, Brian Dennehy. He is as good as he ever was in Andrew Ahn's lovely and sensitive "Driveways." This Independent Spirit Award nominated film is the story of an unlikely friendship between an elderly man and a young boy, struggling to find his footing in the world after he's been uprooted to a new town with his mother (Hong Chau). Don't miss this sweet gem, and raise a beer to the wonderful Dennehy. Available on VOD and digital platforms.

LISTEN

Go gaga: Lady Gaga's highly anticipated, "Chromatica," was released Friday. The superstar's 16-track, sixth studio album executive produced by Gaga and BloodPop will feature collaborations with Ariana Grande, Elton John and Blackpink and will be released by Interscope Records. The first single from the album, "Stupid Love," came out in February and debuted at No. 1 on iTunes in 58 countries. It has since amassed 300 million streams worldwide and marks Gaga's 16th Billboard Top 10 hit.

See the original post here:

CHECK IT OUT: New from Lady Gaga; take a wild ride; beach reading; and a screen gem - Wicked Local

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When I met David Bronner at a cannabis dispensary in Berkeley, California, last fallapproximately 1,000 years ago in the B.C., or before-coronavirus erathe CEO of Dr. Bronners Magic Soaps made good on my hunch that the Southern Californiacompany, known for its minty tingle and wordy label, is one of the few American corporations that give zero fucks.

In a good way.

Id arrived at Berkeley Patients Group early, to get settled in before Bronner and his partner, Mia Hardwick, arrived. I recall thinking that if a doctors office and Hot Topic had a baby, this is almost certainly what itd look like. The Misfits played overhead, almost, just almost pulling you out of the distinctly clinical and well-lit surroundings. Beneath the large glass display sat various types of cannabis flower, neatly arranged: Jack Herer, Biscotti, Gorilla Glue #4, Pineapple Punch.

Bronner showed up looking less the part of Company Executive than California Dude, in clay-colored, natural linen pants and a T-shirt, his long hair pulled into a ponytail and tucked under a cap. But it fithis official title, after all, is actually Cosmic Engagement Officer. He had to hunch his over-6-foot frame to get a good look at the inventory.

Could we check out a Brother Davids Pineapple Punch? he asked the budtender.

She handed him a small, brown paper box. Like fresh juicy pineapples after an amazing day at the beach, a sticker on it read, Pineapple Punch is your cannabis partner for sunshine, freedom and creative flow.It boasted about being grown under the California Sun, In the Soil of Mother Earth, without chemicals, by fairly paid family farmers.

Ill actually go ahead and buy one. I already know its really good, Bronner said, with a knowing smile.

Hes tried it, of courselikely many times. Pineapple Punch is a product from Bronners new(ish) cannabis line, Brother Davids. Launched on Earth Day last year, April 22, Brother Davids is an entity separate from the organic soap empire founded by Davids grandfather in 1948 and is a means to introduceto the market a chemical-free, fair labor, cannabis program created with help from Bronner, Sun+Earth Certified. Because marijuana is still illegal at the federal level, he explained to me, it cant be legally certified as organic, a determination made by the USDA, and consumers are largely left without knowing which growers are pesticide-free or employ fair labor practices. Sun+Earth Certified aims to be that standard.

This type of outside-the-box innovation is something of an informal guiding principle for the guy behind Dr. Bronners; its almost quite literally that insufferable trope, Be the change you want to see. If the soap company needs something to make its products ethically and environmentally friendly, and that something doesnt already exist (or its not currently legal), Dr. Bronners will actually make change happen.

Its practically baked into the companys DNA: In addition to founding the company, Emanuel Bronneraka Dr. Bronner, though he wasnt really a doctorheld strong moral convictions. He gave lectures on the interconnectedness of humanity and sold soap in downtown Los Angeles. In 1950, after Emanuel realized people were simply taking the soap and leaving, he printed his sermons on the label. Dr. Bronners bottles still carry Emanuels message: We are All-One or None!

Over the years, Dr. Bronners has put in real work to make change happen, unlike so many brands now trying to capitalize on socially conscious consumers (see this piece from my colleague Inae Oh from earlier this week if you dont know what I mean). The self-described activist brand hasput its weight behind causes like animal welfare, criminal justice reform, and fair pay. It has spent millions in support of state ballot measures that require the labeling of genetically modified foods. Back in 2001, Dr. Bronners helped leada lawsuit against the Drug Enforcement Agency to allow oil derived from hemp in their products, eventually notching a win at the Ninth Circuit Court of Appeals in 2004.Bronner himself has been arrested twice for hemp-related protests: First for planting hemp seeds on the lawn of the Arlington, Virginia, DEA Museum in 2009, and then again in 2012 for pressing oil from hemp plants in front of the White House while locked in a steel cage. And, as my former Mother Jones colleague Josh Harkinson chronicled after spending a wild evening drinking beers and smoking spliffs with Bronner back in 2014, the exec grew his own fair-trade, organic palm oil and coconut oil overseas when he couldnt source it elsewhere.

In 2019 alone, it donated nearly $7 millionabout 5 percent of its revenueto a variety of charitable causes. But of all causes last year, Dr. Bronners gave the biggest bit of changemore than $3 millionto drug policy reform. In the past, Dr. Bronners drug-related activism largely centered on cannabis legalization, but now the company is turning its energy to a radical, new frontier: psychedelics.

That was our focus when we met up last fall, back when it was, needless to say, a simpler time. News of the novel coronavirusand the corresponding wild demand for hygienic productswouldnt come until months later. Today, the soap company has seen demand for its products spike, but at the same time its kept a keen focus on supplying soap and sanitizers to front-line workers and at-risk communities. Its been nuts, Bronner told me over the phone last month. Production has been dialed up to 11, he said, and during the past couple of months, the company simply hasnt been able to meet all its orders. Still, as of mid-May, it had donated more than 25,000 units of hand sanitizer and soap to those in need; it had also given $20,000 to the San Diego COVID-19 Community Response Fund and $50,000 to Californias Immigrant Resilience Fund,which is helping to support the 2 million undocumented Californians who are not eligible for federal stimulus money. (Dr. Bronners also announced this week that its donating $25,000 to organizations, both in Minnesota and nationally, that are working to end anti-Black racism and abuse.)

Even without the increase in coronavirus-related demand, Dr. Bronners constructive capitalism model has seemed to work for its bottom line: The company has grown every year since at least 2010, and in 2019, brought in $129 million in salesa 60 percent jump from what it sold fiveyears earlier.

We definitely get told, angrily, to just stick to making soap by whoever doesnt like the position were taking on a given issue, Bronner said. But I would say overall, even people who disagree with us respect that were out there standing up for our beliefs.

As Bronner likes to say, Whatever your subculture is, were your soap.

Dr. Bronners founder, Emanuel Bronner, with liquid soapDr. Bronners

As we drove across town in his rented Kia Soul to the Peoples Cafe, a vegan coffee shop, Bronner told me, I totally believe that we have a right to use psychedelics responsibly in our own home, out in nature. He pointed out that research shows psilocybin, a psychedelic chemical found in hallucinogenic mushrooms, can have healing properties, especially for people struggling with mental health conditions like addiction and anxiety. As he wrote in a September blog post on the companys website, We firmly believe that the integration of psilocybin therapyis crucial to healing epidemic rates of depression, anxiety, and addiction. (In 2018 and again in 2019, the Food and Drug Administration granted breakthrough status to psilocybin for treating depression and major depressive disorder, a designation based on promising clinical evidence that allows companies to expedite a drugs development. Some of the most advanced findings have been with cancer patients, where research shows psilocybin can decrease depression and anxiety.)

Just before we met last year, Bronner and Hardwick had flown in from Portland, Oregon, where they had attended the official launch of an effort to essentially legalize magic mushrooms for these purposes. IP 34 is a state ballot initiative Oregon voters will likely consider in November that would legalize psilocybin for therapeutic uses in restricted settingsa possible model for the rest of the country, according to Bronner. Dr. Bronners, he had announced the day before, would donate $150,000 to the initiative. Last year, the company had financially supported the passage of Initiated Ordinance 301 in Denver, Colorado, which made history when it became the first city to decriminalize psilocybin. (Oakland, California, became the second major city to do the samelast summer.)

But like all things, the coronavirus threw a wrench into big plans for 2020. While Oregon had most of its signaturesto move the initiative forward before the pandemic hit, Bronnerannounced last month that the company would be giving an additional $1 million to the campaign supporting IP 34. Were stepping up bigger than we expected in Oregon, just because its a difficult fundraising landscape right now, Bronner told me. Its likely IP 34 will reach a goal of 145,000 signatures before the July 2 deadlineone way or the other, were gonna make it happen, Bronner said. Still, the company had planned to sponsor an Oregon-based conference on psilocybin therapy which was canceled because of COVID-19. The coronavirus also effectively ended a similar initiative in Californiathey didnt have enough signatures when COVID hit to finish the deal, Bronner said.

As we walked up to the restaurant, I asked Bronner about his own psychedelic experiences, which he has been open about in the past. He told me that his first encounter was with mushrooms, in a friends room while he was studying biology at Harvard. I remember looking down on my arm, and whoahe recalled thinkingwhat does it mean that Im in quantum continuum with my environment? At a quantum level, theres not a difference between me and the world. And when I eat and I poop, the world is pouring through me. He believes that in addition to helping people suffering from mental illness, this feeling of connectedness with the world brought on by psychedelics may help people be better stewards of the planet. Bronner said the response to his companys push for psilocybin therapy has been very positive, at least on social media.

David Bronner protested the federal ban on hemp by locking himself in a cage full of hemp plants in Washington, DC, in 2012.Bill OLeary/The Washington Post/Getty

While the Oregon psilocybin initiative is what Bronner saidbetween bites of a vegan chicken quinoa burrito and a vegan omelet he split with Hardwickhe was most excited about for 2020, he was still focused on the broader mission of fair cannabis policy. States including Montana, South Dakota, and Arizona could see recreational, adult-use pot on the ballot in November, meaning these will be the key battleground states for Dr. Bronners. (Efforts in Oklahoma, Missouri, and Ohio have stalled out due to COVID, organizers say.) In all, the company plans to spend north of $2 millionin 2020 on drug policy reform, split between support for legalizing cannabis, approving psilocybin therapy, and replacing jail time with addiction treatment. (Ballot initiatives on jail diversion are in the works in Oregon and Washington, though its unclear if these initiatives will have enough signatures to qualify.) Dr. Bronners support will translate to donations, but also social and marketing resources, maybe even some limited-edition soap bottles.Dr. Bronners has in the past printed labels to build support for issues including GMO labeling, minimum wage, and regenerative organic agriculture. Its currently prepping a special bottle dedicated to integrating psychedelic therapy to launch in September, according to Bronner.

Its almost like, maybe this company is too good.Initially, I wondered if Dr. Bronners was practicing some kind of dark magic; how could an activist company, an unapologetic one at that, also be so profitable? Oh, and did I mention Dr. Bronners caps executives salaries at five times that of the lowest-paid employee? Im pretty much a glass-half-full kind of person, but still, I wanted to find something to latch on to, be skeptical of, poke holes in, or, at the very least, find ridiculous. While maybe there was just a little bit of the latter, what I saw really was a refreshing kind of corporate existence in an era when a self-serving business executive is literally running the country. Its definitely a more sucky environment, Bronner says of working for reform under Trump, but [George H.W.] Bush sucked, you know? Its not new. You just kind of keep workingeven under Obama, there was plenty of shitty things. You just gotta do what you can.

Toward the end of lunch, I asked Bronner which of the then-plentiful Democratic presidential candidates he liked. He said he didnt have a favorite and hadnt really been following the campaigns, but said he supported senators Bernie Sanders and Elizabeth Warren, though he reallyliked Sen. Cory Booker. Finishing off a cardamom chai tea with oat milk, Bronner said Booker, who has backed legislation to legalize cannabis nationwide, is super dope. Getting at least one prediction right about 2020, he added, I mean, he doesnt have much of a chance, but hes awesome.

I want to give him 420 bucks, Bronner said to Hardwick. Remind me were going to give him 420 bucks. (I checked back later; he did.)

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Dr. Bronner's Soaps Wants to Protect You From COVIDand Legalize Your Right to Magic Mushrooms - Mother Jones