If January is anything to go by, itās going to be an incredibly busy year in the psychedelics space. In the last week alone we learned of a new fast-track designation for MAPSā MDMA-assisted therapy for PTSD in the UK; a new company thatās seeking to ācontrolā the supply of peyote in Canada; the FDA released a hold on MindMedās LSD for generalised anxiety disorders study; new psychedelic drug policy reform initiatives were revealed; and much, much more.
Todayās Bulletin is lengthy ā buckle upā¦
Psychedelic Sector News
MAPS Receives Fast Track Designation in UK
MAPSā MDMA-assisted therapy for PTSD has scored an Innovation Passport under the UKās ILAP Scheme.
Psilocybin Alpha understands that Small Pharmaās SPL026 DMT candidate was the first psychedelic to receive the new fast-track designation, which we reported on in October 2021. In that Bulletin, we also gave a brief explanation of the program, named the Innovative Licensing and Access Pathway (ILAP):
In a similar manner to the FDAās fast-track designation, the ILAP aims to accelerate time to market and facilitate patient access to emerging novel treatments. The ILAP connects other key stakeholders in the drug development and roll-out process, including the countryās National Health Service (NHS) and the National Institute for Health and Care Excellence (NICE). The program was touted as a way to encourage the development of innovative medicines in the UK post-Brexit.
Since then we have learned of two further psychedelic candidates that have received ILAP designations, suggesting that post-Brexit Britain is keen to facilitate the development of innovative drugs and therapies: including those relating to psychedelics.
The first of these two further announcements was Eleusis, which shared the news in a press release announcing its SPAC merger. Then, earlier this week MAPS announced that it has become the latest organisation to receive an Innovation Passport under the new scheme, for MDMA as an adjunct therapy to PTSD.
According to MAPS, 41 treatments have received the designation since the pathway launched in January 2021. That means that psychedelic candidates represent just over 7% of all designations granted to date.
Company Seeks to āSecure Existing Supplyā of Peyote in Canada
A press release last Friday announced the acquisition of Lophos Pharma, āa psychedelic research company primarily focused on novel therapeutic treatments derived from Peyote (Lophophora williamsii).ā The acquiring company explained that it hopes Lophos will be able to use Peyote āto treat indications ranging from weight loss and addiction, to anxiety and depression.ā
The companyās Advisors include PharmaTher CEO Fabio Chianelli and Director Joshua Therman, and Revive Therapeutics CEO Michael Frank.
In the companyās investor presentation, Lophos explained that it is ācurrently securing the existing supply of Peyote (approx. 2,500 Peyote plants) from independent growers across Canada.ā The company goes on to explain that the long cultivation cycle of the Peyote plant, around 3 to 12 years (though, it can take up to 13 years for a plant to mature), ācreates a significant barrier to entry for competitors,ā going on to claim that, āLophos has a head start and is preparing to scale.ā
If it werenāt clear enough, under a heading titled The Benefits of Peyote the deck reads, āCommercial Benefits: Potential control over short-term and long-term supply.ā
Now, some context: peyote is an endangered, yet spiritually sacred, plant. This is not an obscure fact. Californiaās SB 519 decrim. bill, for example, excluded mescaline and peyote in order to ensure the endangered plant remains available for use in Native American spiritual practices.
Mescaline can, of course, be produced synthetically in order to not put further strain on dwindling natural stocks of peyote. Indeed, Journey Colab is looking to develop synthetic mescaline (lead candidate JOUR-001) for the treatment of Alcohol Use Disorder.
Read more on mescaline in our May 22nd, 2021 Bulletin:
Mescaline is a phenethylamine found in a number of cactus species, including peyote (Lophophora williamsii) and San Pedro. Aside from being popularised in the psychedelic movement of the mid-Century, and in the pages of Aldous HuxleyāsĀ The Doors of Perception, mescaline has been used for many thousands of years by Native Americans.Ā
Mike Jayās book,Ā Mescaline: A Global History of the First Psychedelic, charts the history of this hallucinogenic alkaloid: from indigenous use and colonial repression through to attempts by Western pharmaceutical companies to commercialize the substance. If published today, Jayās book may include a thirteenth chapter chronicling the resurgence in interest around classical psychedelics, including the present MindMed study, and apparent interest from other companies such as Journey Colab.
New Publication on Non-Hallucinogenic Psychedelic Analogs
Note: we have covered efforts to validate and develop ānon-hallucinogenic psychedelicsā (sometimes called āpsychoplastogensā) for some time now, so we wonāt repeat the basics.
A new publication in Science (Cao et al., 2022) presents a number of psychedelic analogs that appear to be non-hallucinogenic, yet display antidepressant-like activity in mice.
A plain-English write-up of the paper explains that researchers believe they have āteased apart the molecular interactions responsible for psychedelicsā antidepressive effects from those that cause hallucinations.ā
As with other research into non-hallucinogenic psychedelic analogs, the six crystal structures of compounds produced by Sheng Wang and colleagues have only been studied in mice.
We may begin to see data from in-human trials relatively soon, though. Delix Therapeutics, for example, hopes to begin its first clinical trials later this year.
As mentioned in our earlier coverage of this research theme, this work gets at a much more foundational question: are the subjective effects of psychedelics necessary for their apparent therapeutic effects?
Rather than waiting to see whether ānon-hallucinogenic psychedelicsā prove efficacious (and, non-hallucinogenic) in human studies, some researchers are tackling the root of the question.
As Michael Haichin shared with the Psychedelic Pharmacist Associationās members, there are a number of innovative attempts to address this important question.
One of these efforts is a Phase 4 clinical trial devised by Stanfordās Boris Heifets, in which half of the patients undergoing joint replacement surgery are given a ketamine infusion while under anaesthesia, while the other half receive a placebo saline solution.
Why might this help us understand whether the subjective effects of ketamine are important in its therapeutic effects? Well, if someoneās anesthetised, theyāre not going to experience the subjective effects of a psychedelic.
But, as Haichin notes, whether ketamine is appropriately considered a psychedelic is contentious, and the evidence base for associations between the efficacy of ketamine and its subjective effects is somewhat messy and may be indication specific. The study is expected to complete soon.
Another trial that seeks to get to the heart of this question, dubbed the RECAP study, is led by the team at the University of Wisconsin-Madisonās Transdisciplinary Center for Research in Psychoactive Substances. Their approach employs midazolam, a benzodiazepine that induces amnesia (the loss of memories).
In the trial, a single 25mg dose of psilocybin will be administered alongside repeated IV midazolam that would āmaintain conscious experience while inducing subsequent amnesia for the experience upon its conclusion.ā
At this stage, the Phase 1 trial is seeking to find an appropriate dosing regimen of midazolam that allows the psychedelic experience to occur while also inducing amnesia for the experience. In later phases of the program, researchers hope to be able to test whether memory of the subjective experience is correlated to its long-term antidepressant effects.
FDA Clears MindMed IND, Allowing Phase 2b LSD Trial to Proceed
In our last Bulletin of 2021 we reported that the FDA issued a clinical hold on MindMedās Phase 2b trial of LSD for generalised anxiety disorder.
As Matt Baggott noted on Twitter at the time, clinical holds arenāt āparticularly worrisome or even unexpected.ā Baggott explained that when an Investigational New Drug application (IND) is submitted to the FDA, the agency has thirty days to respond, otherwise the study may begin. A clinical hold, then, is the FDAās āway of saying ādonāt start until we say you can,ā he explained.
Still, the clinical hold, alongside changes to the companyās leadership, did little to inspire investor confidence.
On Tuesday, however, the company announced that the FDA has cleared its IND for LSD, āenabling initiation of Phase 2b dose-optimization trial of MM-120 in early 2022.ā The stock rallied over 20% on the news, closing the week higher.
Other Company News
- atai Life Sciences launches Invyxis to accelerate discovery of next-generation mental health treatments;
- Algernon Pharmaceuticals discloses novel salt patent strategy as part of its DMT intellectual property;
- Awakn Life Sciences files patent application for new class of entactogen-like molecules to treat range of addictions;
- Beckley Psytech announces first cohort of psychotherapists have begun training for 5-MeO-DMT for TRD phase 2 trials;
- Filament Health subsidiary Psilo Scientific announces inclusion in Health Canada list of licensed psilocybin producers;
- MINDCURE announces financial results for Q2 2022 ($13.4m cash and equivalents);
- Mindset Pharma enters manufacturing agreement with CDMO to produce psilocybin drug candidate MSP-1014;
- Mydecine partners with Combat Stress to treat PTSD in veterans;
- Nova Mentis and KGK Science form tactical partnership;
- Numinus graduates to OTCQX Best Market; identified as licensed psilocybin supplier by Health Canada;
- Psyched Wellness provides update on anti-inflammatory study with National Research Council of Canada;
- Red Light Hollandās partner CCrest Laboratories approved by Health Canada to supply psilocybin to SAP.
Weekend Reading
New Year, New Legislative Efforts Primed to Increase Access to Psychedelics
Commentary fromĀ Logan Murr, legal intern at Calyx Law
A commitment to revisiting the legal framework governing psychedelics remains strong in many states. Since 2022 began, several states have introduced legislative measures to promote intelligent discussion about and an increase access to psychedelics.
While a consensus has yet to emerge among the states about how to approach psychedelics, a potentially transformative conversation has begun in several states. For example, on January 17, 2022, House Bill 167 was introduced in Utah. This bill proposed the creation of a task force charged with āprovid[ing] evidence-based recommendations on any psychotherapy drug that the task force determines may enhance psychotherapy when treating a mental illness.ā Similarly, a pair of legislators in Colorado opted to sponsor HB 22-1116 which would create a panel charged with investigating the possible uses of plant-based medicines in mental health treatment.
Oregon became the first state to legalize psilocybin-assisted therapy in November 2020. This year, Oregon representatives have proposed SB 1580 to create the āTask Force on Psilocybin Equity.ā Unlike the proposed task forces in Colorado and Utah which aim to study the possible uses of psychedelics in mental health treatment, Oregonās proposed task force hopes to address issues related to equity and access to psilocybin-assisted therapy. The task force is charged with making recommendations about a variety of equity and access topics including how to address barriers keeping people of color and people who are low income from participating in Oregonās burgeoning psilocybin services program as business owners, facilitators, or clients.
Other states have recently proposed decriminalizing certain scheduled substances. On January 10, 2022, a Kansas lawmaker introduced HB 2465, aimed at reducing the penalty for individuals cultivating or possessing small quantities (less than 50g) of psilocybin or psilocin. Virginia is another state with new decriminalization efforts underway. Virginia legislators proposed decriminalizing possession of psilocybin and psilocin with the introduction of SB 262 on January 11, 2022. A similar bill, HB 898, was also introduced in Virginia the following day which aimed to decriminalize ibogaine and peyote in addition to psilocybin and psilocin. Launching a decriminalization campaign of their own, Missouri lawmakers proposed HB 2469 on January 18, 2022, which would decriminalize low-level possession of several scheduled substances, including LSD, MDMA, and psilocybin.
Unsatisfied with the current state of mental health treatment, Colorado activists introduced two similar ballot initiatives in December 2021, Initiative 49, and Initiative 50, which would allow for personal cultivation, possession and use of psilocybin and psilocin. Additionally, these ballot measures would set up a system of regulated healing centers where individuals over 21 could receive psilocybin-assisted therapy under the guidance of licensed facilitators.
āThe Future of Psychedelic Medicine Will Be Drugs Youāve Never Heard Ofā
Shayla Loveās latest for Vice demystifies the frenzy around psychedelic and analogues, derivatives and new chemical entities (NCEs).
Itās not a guarantee that all of these new compounds will work; nine out of 10 drugs fail to make it through the drug discovery pipeline.
But the proposed molecules do raise interesting questions we donāt have answers to. How important is the experience of the drug? How critical is the time period? Is more neuroplasticity always a good thing?
Side note: Psilocybin Alphaās Josh Hardman appeared on Psychedelics Todayās podcast earlier this week, and touched on this topic: āā¦I think that might be a big story in 2022, when we start realizing that a lot of these supposedly new chemical entities either start failing in preclinical work or in Phase 1 work or theyāre just not that remarkably different.ā
The Economist Publishes Two Articles and a Podcast on Psychedelics
The January 29th edition of The Economist contains two articles on psychedelics, both of which feature glowing headlines.
Psychedelic therapy shows great promise. More states should legalise it
The first appears in the magazineās Leaders segment, and focuses on āOregonās trailblazingā legalisation of supervised psilocybin therapy via Measure 109.
The piece ends on a measured note, which ties Oregonās Measure 109 into the broader drug policy conversation:
āSome may find psilocybin does not bring them all they hoped for. The drug is not a cure-all; and Oregonās policies may need to be tweaked. But the stateās voters deserve praise for their clear-headed sense of proportion, too long absent from American drug policy. More states should follow Oregonās lead of cautious experimentation. Psychedelic drugs show tremendous promise. Initiatives like Oregonās are essential if they are to realise their potential to help those who today must bear their suffering.ā
Sensible policy on psychedelic drugs is growing more common
This second article appears in the United States section, with the subheading, āThey show tremendous potential in treating certain mental-health disorders.ā
The piece cites the growing research base, expansion of business interest, and curiously bipartisan support for psychedelic policy reform.
āNor is it just Europeans and coastal liberals interested in psychedelicsā potential. Texas legalised research into them last year; the stateās flagship medical school opened the Centre for Psychedelic Research and Therapy in December.ā
Just as we went to publish this Bulletin, The Economist shared a podcast episode on psychedelics, too. The episode, titled LSDecriminalise, is part of their Checks and Balances series, and asks: Should psychedelics be more widely available?
A ārough guideā to psychedelics
Nikhil Shah, who evades conventional job descriptions (letās just say multi-hyphenate entrepreneur and Mixcloud co-founder), has published a five-part ārough guideā to psychedelics over on Medium. The series covers the āhistory, experience, science, safety and business of psychedelics.ā
Psychedelic and Plant Medicines: A Portal to Transformative Realms of Possibility
This piece in the Winter 2021 of Nonprofit Quarterly starts with a bold claim:
āIf anything has the potential to alter the grievous state of mental health and well-being and move us toward āvisionary, transformative and liberatory realms of possibility,ā it is the psychedelic renaissance we are on the cusp of today.ā
The author, Kasey Crown, trained in MDMA-assisted therapy for PTSD with MAPS in 2018, and in this article charts the course of psychedelic-assisted therapy: from the importance of setting intentions, right through to integration.
5-Page Primer on Psychedelics Published in Current Biology
A five-page primer on psychedelics was published this week, offering an introduction to the scientific data. Co-author Alex Kwan wrote on Twitter, āwe wanted a concise and accurate piece to share with undergraduates, journalists, and others who want to know more.ā
This (free) primer on Psychedelics is now available in Current Biology.
(Shout-out to our very own Michael Haichin who reviewed the draft and gave feedback).
Registration is Now Open for the 2nd Annual Psychedelic Therapeutics & Drug Development Conference
Taking place in-person on May 23-24, 2022 in Washington, DC, this event has been organized to bring together the worldās leading researchers and leaders in academia, industry, the non-profit sector and government to discuss the challenges and opportunities facing those engaged in the research and development of psychedelics for various health conditions with considerable unmet need.Ā
Speakers and panelists will cover important topics such as Clinical Trial Design, Intellectual Property, Regulatory Guidance, Psychedelic Drug Delivery, Commercialization, Legal Issues, Emerging Preclinical Science, and New Clinical Data among other topics.
For more information, visitĀ www.psychedelics-conference.com.
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