What a year for psychedelics! It feels like we’ve come a long way since the sector explode in 2019-2020, the launch of Benzinga's Psyched, companies’ massive migration from private to public, MAPS’ initiation of Phase 3 MDMA trials, the surge of the psilocybin wave, the first cases of decriminalization and use exemption of certain psychedelics. Then followed the dawn of the first EFTs in the sector, a rise in private funding (including major investment banks) and the growing public acceptance partly thanks to vast media coverage.
After the initial hype, by 2022 the psychedelic world seems to have somewhat grown and settled down. Both science and investment have sobered up, compared to prior years in which everything seemed possible and psychedelics were seen as the cure for all our ills.
Meanwhile, mainstream psychedelic adoption has grown as well as government measures towards legalization at all levels - cities, states and federal - in response to public demands as well as scientific evidence of psychedelics’ therapeutic potential. The conservation of natural plant species is becoming more of a hot topic.
What this year has taught us, is that a more realistic approach -though companies are getting more creative, which seems to be the best way to move forward to eventually be able to offer better treatments for several of the health issues we humans suffer at a global scale.
Now, let’s get to the most remarkable milestones achieved and the hottest topics of 2022.
Contents
- MAPS' PTSD Trial
- Congressional Discussions
- Colorado's Pyschedelics Reform Bill
- Canada’s Special Access Program
- Awakn’s Ketamine-Assisted Psychotherapy For Alcohol Use Disorder
- MindMed's Trial On LSD-Assisted Therapy For Anxiety Disorders
- The Year Of Psilocybin
- Oregon's Regulations
- Celebs Get On Board
- Mixed Financial Data
- The Benzinga Psychedelics Capital Conference
MAPS' PTSD Trial
1) As part of the most important psychedelic studies, the Multidisciplinary Association of Psychedelic Studies (MAPS)’ Phase 3 study of MDMA-assisted therapy for Post-Traumatic Stress Disorder (PTSD) completed its second trial.
Still expecting topline results publications, the first half of MAPS’ study results were very much successful, with 67% of participants no longer exhibiting PTSD symptoms following the study compared with 32% in the therapy-only group. Participants reported lower instances of eating disorders, alcohol use and substance use.
While other alternatives are being studied for that condition -including an MDMA-based compound and psilocybin,- MAPP2 represents the most advanced psychedelic clinical development and holds the highest chances of getting MDMA approved by the FDA as a legal treatment for PTSD.
The expected market approval in 2024 could generate over $1 billion by 2026.
Congressional Discussions
2) Congress discussed psychedelics on a regular basis in 2022 with an increasing number of legislators demanding further research and filing bills including decriminalization and drug policy reform as part of harm reduction services and novel treatments to aid in the global mental health crisis which has brought substance use disorders to first order.
One of the most discussed topics was the need for R&D advancement of these medicines for the veteran population, with several senators, including Reps. Matt Gaetz and AOC filing measures towards its concretion.
Another was access to psychedelics for end-of-life patients through the federal Right to Try laws, a battle in which the DEA is directly involved and whose last chapter was the filing of the Breakthrough Therapies Act by Sens. Booker and Paul.
Congress principals have encountered recognition and support among several federal health agencies, and even the promise of a task force towards further research.
In November, a Congressional Psychedelics Caucus was created to lead talks on psychedelics as potential therapeutics and act as a public educational resource.
The DEA also undertook psychedelics discussion, most noticeably in the form of protests and lawsuits on behalf of advocates demanding access for terminally ill patients, and later through several scheduling attempts to ban certain psychedelics that were finally blocked by scientific activists. Although the psychedelics rage seems to have reached the agency too, proof of which is its recent update of the already higher quotas in favor of psychedelics research.
Colorado's Pyschedelics Reform Bill
3) Colorado’s psychedelics reform Prop. 122 was approved in November’s elections and is now officially certified, allowing for legal access to psychedelic medicine for adults over 21 through a regulated framework. While psilocybin is the substance that will be most immediately available for those in need, though not expected to to happen until 2025,-other natural medicines could eventually be lawfully accessed as well.
See also: Millennials Tipped The Scales In Colorado Voting, And Psychedelics Laws Are In Their Crosshairs
According to a recent report, Colorado’s market could become the nation’s biggest in terms of psilocybin services, accounting for $205 million annually.
Other places in the US that have made advancements in psychedelics reform are Utah; Pennsylvania; Michigan’s Hazel Park, East Lansing and statewide attempt; Hawaii; Georgia; Maryland; Oklahoma; Massachusetts; Maine; Washington State; Connecticut; New York; New Jersey; Aspen; Atlanta; New Mexico; Illinois; Missouri; and in California, San Francisco’s decriminalization, Berkeley’s proposal, and the freshly re-introduced statewide bill.
Outside the US, the UK might just become the next psychedelics hub, with petitions from psychiatrists and the general public towards rescheduling psychedelics.
Australia is another place where psychedelics seem to be gaining recognition, with partnerships studying neuroplasticity, a health insurer ready to provide psychedelics-assisted therapy coverage, new research centers for issues like eating disorders, and a recent visit to federal health officials by renowned professor David Nutt.
Canada’s Special Access Program
4) Canada’s Special Access Program continued to be a source of psychedelic-assisted therapy for severe cases in need of innovative, evidence-based treatments, with Alberta becoming the first province regulating this kind of treatment.
The country also provided federal grants for research and patents for novel and classic psychedelics and has recently provided guidelines for more standardized psychedelics research, while two doctors in Quebec were the first to receive full state costs coverage of psilocybin therapy.
Nonetheless, the state’s health authority faced several protests and legal actions this year as well. Advocates recently confronted federal health ministers. All of these movements called for broader access to psilocybin therapy.
Awakn’s Ketamine-Assisted Psychotherapy For Alcohol Use Disorder
5) Awakn Life Sciences AWKNF’s Ketamine-Assisted Psychotherapy (KAP) for Alcohol Use Disorder (AUD) is the fastest-moving treatment, in terms of commercial and scientific success.
Its Phase 2a/b trial results showed those who received KAP accomplished total abstinence in 162 of 180 days in the following 6-month period, achieving an increase in abstinence from around 2% prior to the trial to 86% post-trial. This adds to 2.7 times less risk of relapse for those who completed the ketamine therapy regimen compared to those who just received the therapy.
And the risk of mortality significantly decreased, too: 1 in 8 patients would have died within 12 months without treatment, while that number decreased to 1 in 80 following the treatment.
Awakn is now set to launch its first Phase 3 trial on KAP for AUD. Importantly, the study will be greatly funded by the UK National Health Service, which discloses the belief in this treatment as well as the need for it both at the country and global levels.
On a broader spectrum, ketamine therapy expansion is on the rise as companies build national networks of clinics, some offering different treatment options and modalities. In terms of research, it is being studied for treating other addictions and conditions such as fibromyalgia.
MindMed's Trial On LSD-Assisted Therapy For Anxiety Disorders
6) MindMed MNMD’s Phase 2 trial on LSD-assisted therapy for anxiety disorders was successfully completed, with data showing 65% of patients’ anxiety levels dropped by at least 30%, with benefits lasting at least 6 weeks post-treatment.
Other measures such as depression levels were also helped by the LSD-assisted therapy and treatment was well tolerated.
The company’s next step is a Phase 2b trial, this time aiming to treat Generalized Anxiety Disorder (GAD) with LSD. Should that trial continue with promising results, the first Phase 3 LSD trial would most likely take place in late 2023-early 2024.
Meanwhile, LSD is being tested to treat other conditions such as depression -with microdosing showing positive outcomes so far- and Alzheimer’s.
The Year Of Psilocybin
7) Psilocybin has settled as one of the favorites among psychedelics. So much news on this front that it’s hard to summarize. But let’s try.
To view the increasing conditions that psilocybin could potentially help treat better than traditional antidepressants -see palliative care, smoking cessation, obsessive-compulsive disorder, major depressive disorder, type 2 bipolar disorder, overeating and anorexia nervosa, alcohol use disorder, meth addiction, symptoms leading to autism disorder, autism in adults, as well as adjustment disorder due to incurable diagnosis. This is the natural psychedelic that is undergoing more market growth.
Though psilocybin is still illegal, as are all the rest of the psychedelics, companies are gearing up with more acres for natural mushroom cultivation and expansion, nabbing patents for their extraction and standardization processes, and creating new psilocybin products such as mushroom pills and tea. A biosynthetic version of the drug is on the market, too.
Even microdosing clinical trials are taking place. Their focus is within the broad spectrum of general well-being to PTSD.
And yet, the most advanced clinical trial on psilocybin to date is COMPASS Pathways' CMPS’ Phase IIb study on Treatment-Resistant Depression (TRD), which will be followed by two concurrent Phase 3 trials already designed and coming up in 2023.
See here a broad look at what results from the COMPASS’ Phase IIb clinical trial could mean for the future of psychedelic-assisted therapies for cases of Treatment-Resistant Depression.
Oregon's Regulations
8) Oregon was the first US state to legalize psychedelic-assisted therapy in 2020 and currently concluded its process of creating regulations around upcoming psilocybin services, including matters related to licenses, training and treatment accessibility. This included several instances where public participation took place, and some psychedelics companies got involved.
On the other hand, throughout the year the state has seen several of its localities debating over the possibility of opting out of offering these services in their territories, a matter that was ultimately resolved by voters in the November 8 midterms.
Oregon’s total addressable market is expected to be worth $165 million yearly.
Celebs Get On Board
9) Media coverage ranked high this year along with many celebs -see Kevin Harrington, Jaden Smith, Joe Rogan, Jon Stewart, Luke Rockhold, Aaron Rodgers, Trevor Noah, the wealthy, even an ex-bishop and a senator who acknowledged the power of psychedelics. A Netflix series launche which provided coverage of the topic among other amazing content involving Bowie and Cary Grant’s experiences with the substances.
Of course, Tesla TSLA’s CEO Elon Musk did not miss the chance to get into the conversation, as he’s been doing over the last several years, something some investors find “interesting.”
As for public opinion, a couple of important polls revealed data on consumption and beliefs, most noticeably a federal survey showing the biggest population using psychedelics is currently adults. Another reflected that as many as 50% of Americans support psychedelics legalization for therapeutic purposes, one sharing psychiatrists’ thoughts on psychedelics policy, and another predicting the year when psychedelics will become country-wide legal.
Mixed Financial Data
10) In financing we saw mixed results. The initial rush seems to have settled down, and investors opting for the sector know that the drug development industry is a long-term shot especially considering that psychedelics have not yet been approved by the Food and Drug Administration (FDA).
And as not everyone is in a position to support and follow this timeline, the investors’ landscape has certainly changed. This was accompanied by a surprising, first-ever publication of the sector’s news and outlooks by major advisory companies such as KPMG and Morgan Stanley, which reflects the market’s potential to revolutionize the entire medical industry. Patience before the expected, soon-to-be, massive take-off.
In this context, psychedelics companies have made use of financial instruments to support their ongoing developments and studies and not run out of liquidity. Several of them have reached out turned to reverse stock splits -see Mydecine MYCOF, MindMed, Silo Pharma SILO, Clearmind CMND.
Other financing options included loans -atai ATAI-, equity programs -Cybin CYBN-, or even splitting into separate companies for a more specific focus -take Field Trip and Enveric ENVB.
Psychedelic and psychoactive startups have rapidly expanded through private financing. Some examples are Freedom Biosciences, Tony Kroos and former Deutsche Bank-backed HMNC Brain Health, Lusaris Therapeutics, clinicians and drug developers from Massachusetts General Hospital and Harvard Medical School-led Sensorium Therapeutics, and Gilgamesh Pharmaceuticals.
On the investors’ side, some of the names that have come up stronger this year in the sector are Cathie Wood, whose ARK Fund has been heavily investing in psychedelics stocks for the whole part of the year. She sees it as a positive sector. VC fund Palo Santo, whose founders rely on scientific advances, closed a fund for $50 million towards psychedelic therapies.
Meanwhile, the sector’s worth predictions talk about $6.330 million by 2026, and $8.31 billion by 2028.
The Benzinga Psychedelics Capital Conference
11) Benzinga held its first Psychedelics Capital Conference this year. Other important cannabis gatherings have added psychedelics sections to their events, including MjbizCon, SXSW and others. The Davos world forum included a medical psychedelics series in its 2022 edition.
Additionally, earlier this year art auction organizer Christie’s set up an NFT round sale to support psychedelics research.
With a stronger advisory council board, we can only hope that 2023 will bring more exciting news to readers, investors and those bullish over the sector’s progress.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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