- 📑 Analysis: Patent Applications Provide Hints at Terran Biosciences’ Strategy
- 👫 Psychedelic Naïve Couple Were First to Receive Psilocybin Services in Oregon
- ⚕️ AMA to Advocate Against Use of Psychedelics Outside of Trials; Supports Continued Research
- 🗳 Psychedelic Ballot Measure Plans Ramp Up in Massachusetts
- ✒️ NIDA and NIMH Directors Pen Viewpoint on Psychedelics
- 🎥 Video: Christian Angermayer in Conversation with Josh Hardman
and lots more…
Psychedelic Sector News
Analysis: Patent Applications Provide Hints at Terran Biosciences’ Strategy
Last spring, Terran Biosciences boasted that it had a portfolio of more than 150 patents. Since then, most of these patent applications have published.
The company has largely operated in stealth, but analysis of the thousands of pages of patent applications provides some hints at their strategy. In our latest deep dive we consider what Terran’s end game might look like, and how their IP portfolio may impact psychedelic drug developers.
You can read our deep dive here. Here’s a short excerpt from the Closing Thoughts section:
While already expansive, Terran’s patent portfolio continues to grow (reminder: you can explore the company’s other published applications in our tracker). In fact, just as this report went to press, two new PCT applications were published. Accordingly, while the recent unveiling of Terran’s applications have helped shed light on the company’s IP strategy, and allow for speculation as to its commercial strategy, the true extent of its growing patent portfolio remains unclear. As a result it may be that Terran has, for many months now, had its sights set on IP that competes with a slew of drug developers not yet able to be included in this present analysis.
Time will reveal which of Terran’s applications and their constituent claims continue to be pursued, and which survive and pass through further examination. Until this point, when the company’s portfolio crystallises, we are left to speculate on the implications of Terran’s IP activity.
Terran maintains—both in response to our request for comment as well as in a recent interview—that it is not in the business of “just licensing patents”. Rather, Terran’s Clark points out that it has “entire datasets available accompanying these patents which could potentially save enormous costs and years of work, accelerating the development of novel therapies for patients in need.” The logic presumably follows that the additional cost to a drug developer in potentially having to shell out for a licence from Terran might be offset by an easier path through the drug development and commercialisation process.
What’s not given much attention, however, is the fact that many psychedelic drug developers could have explored and pursued solid forms and related IP without Terran’s intervention. In fact, it’s probable that many were already doing this.
In some senses, it’s reminiscent of the animosity directed towards COMPASS Pathways when it emerged it had filed solid form IP on psilocybin, potentially blocking other ongoing drug development. The nonprofit Usona Institute, for example, was working extensively with psilocybin, too. But they had chosen not to file patent applications on those solid forms—despite having performed their own “polymorph screen involving over 150 solvent and non-solvent based screening experiments,” the results of which they published in February 2020.
“We’re a firm believer in ‘a rising tide lifts all boats,’ and our door is always open to prospective partners,” Clark said in an interview earlier this week. But what if the tide was coming in anyway?
One might also ask why Terran would repeatedly wade into crowded waters, targeting compounds that are subject to existing IP claims (in some cases, from multiple parties) and found in the pipelines of other companies. In many cases, if Terran sought to develop and commercialise the candidates claimed in its own IP portfolio, it would need to hope that others’ doors were open, too.
Read our full analysis here.
Psychedelic Naïve Couple Were First to Receive Psilocybin Services in Oregon
Back in May, we spoke with Cathy Jonas at EPIC Healing Eugene as it came to light that her company would be the first licensed psilocybin service centre in Oregon (and the U.S., for that matter). In that piece, we charted her path to licensure, which certainly wasn’t straightforward or economical.
Now that EPIC is serving its first psilocybin clients, we decided to check-in with Cathy and her team.
Cathy explained to us that the first client served psilocybin legally in Oregon was a member of her team, who was seen on May 23rd. While the session was used to prepare staff, all state guidelines had to be followed including the purchasing of psilocybin that was produced, tested and logged in the state’s tracking system. This psilocybin was purchased from Satori Farms.
From there, Cathy’s team rotated staff as clients for three further sessions. The purpose was to ascertain the potency of the psilocybin product and refine the group’s intake process and “flow”. Part of this tinkering included optimising the client experience in EPIC’s “small setting”.
With this staff testing and adjustment process complete by early June, EPIC was ready to accept its first true clients.
The first of these clients were a couple which attended EPIC for their psilocybin session on June 23rd. These are believed to be the first clients to participate in Oregon’s psilocybin services program.
Cathy told us that the couple were psychedelic naïve, meaning they had never tried a psychedelic. They “received 30 mg psilocybin analyte each, equivalent to about 5 grams”, she explained. “Both reported positive experiences”.
While Oregon allows service centres to provide doses of up to 50mg, EPIC has decided to limit their doses to 30mg. A nonprofit psilocybin service centre, Bendable Therapy, provided a 50mg dose to its own first client, as reported by Jane C. Hu at The Microdose.
Next, EPIC delivered psilocybin services to another couple. Cathy told us that her service centre has decided to work with individuals, couples, and groups of up to three people. “For our groups, people need to know each other”, she explained.
Excluding the staff who acted as clients, EPIC has served seven clients as of July 18th.
Elsewhere in Oregon, Myco-Method Psilocybin Facilitator Training Program was issued a Cease and Desist order by the state’s Higher Education Coordinating Commission (HECC) in May. “Students should know that the school is not licensed”, the update from HECC explained, meaning that it is not following state rules to ensure minimum standards. What’s more, if Myco-Method closes shop, enrolled students won’t be eligible to seek any reimbursement from the state’s tuition protection fund.
AMA to Advocate Against Use of Psychedelics Outside of Trials; Supports Continued Research
The House of Delegates of the American Medical Association (AMA) gathered to adopt new policies that address substance use, including those regarding access to overdose reversing medications such as naloxone as well as expanding non-punitive access to prenatal treatment for substance use disorders.
The third policy noted in the associated press release is aimed at “supporting FDA’s role in ensuring the safety of medicinal psychedelics”.
“As lawmakers in some U.S. states have embraced the use of psychedelics, the nation’s physicians expressed concern about legislative efforts that circumvent the role of the U.S. Food and Drug Administration (FDA) to ensure the safety of medication options”, the section begins.
In response, the AMA has adopted a policy that instructs the association to “advocate against the use of any psychedelics or entactogenic agents [..] to treat any psychiatric disorder except those which have received FDA approval” or those prescribed as part of an approved study.
AMA Immediate Past President Jack Resneck said that, while the AMA “appreciates that lawmakers want to help address the mental health crisis in the U.S., [..] there are other straightforward approaches that don’t thwart drug safety assessment and regulation, such as increasing coverage and removing barriers to care for evidence-based treatments.”
Emphasising their belief in the importance of “scientifically valid and well-controlled clinical trials” as the gating factor to medical use, physicians also voted for the AMA to “support continued research and encourage therapeutic discovery into psychedelic and entactogenic agents with the same scientific integrity and regulatory standards applied to other promising drug therapies.”
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Psychedelic Ballot Measure Plans Ramp Up in Massachusetts
A draft of a proposed policy, obtained and dissected by Mason Marks, sheds light on the so-called Plant-Based Psychedelic Substances Health Act. A first read suggests it looks a lot like Colorado’s Natural Medicine Health Act (NMHA) in that it would establish a regulated model of supervised psychedelic services, as well as effectively decriminalise noncommercial use of certain psychedelics (though, the extent of this element is not yet clear).
In terms of the psychedelics covered by the proposal, they’re the same as those featured in the NMHA: psilocybin, psilocin, DMT, mescaline (excluding that which is derived from peyote) and ibogaine.
Interestingly, the psychedelic program contemplated by the proposed Mass. policy would be funded by tax revenues, as opposed to being supported by licence fees as in the case of Oregon’s psilocybin services program. When combined with the low volume of psilocybin services seen thus far (and the inherently low volume of psilocybin products due to the nature of a supervised services model as opposed to, say, a recreational/adult-use/dispensary model), this necessitated relatively high licensing fees for facilitators, manufacturers, testing labs and service centres (training schools were exempt from licence fees). Of course, these fees have equity implications both on the provider (increasing upfront costs) and client side (costs are often passed on to customers).
Oregon is in such a bind that its psilocybin services section has had to go cap-in-hand to taxpayers to ask for a cash injection to tide it over. We covered this in greater detail as part of our Year in Review.
This proposed Massachusetts policy will seek to avoid such issues by levying an excise tax on sales of psychedelics within the program and a local tax on those sales of up to 2%, according to Marks. Given that the product represents a small portion (often around 10% or lower) of the cost of psilocybin services, for example, it’s unclear how levying taxes on the product alone will generate substantial revenues.
While many have shared their excitement around the proposal, others have asked questions about the policy’s backers. The efforts are reportedly being forwarded by New Approach PAC, which successfully passed Oregon and Colorado’s psychedelic ballot initiatives as well as a suite of other drug policy reforms (New Approach cut its teeth in the cannabis reform world). Local activists have pushed back against what they see as a ‘distraction’ from their own efforts by the ‘out-of-state’, ‘DC-based’ PAC.
Speaking to WBUR earlier this month, New Approach’s Ben Unger said that the group will decide whether to proceed with the ballot question in the coming months.
NIDA and NIMH Directors Pen Viewpoint on Psychedelics
The Directors of the National Institute on Drug Abuse (NIDA) and National Institute of Mental Health (NIMH)—billion dollar government research agencies—shared their thoughts on the Potential and Challenges of Psychedelics as Therapeutics in a recent Viewpoint published in JAMA Psychiatry.
The Viewpoint suggests that they’re keen to temper hype around psychedelics. “Despite the promising early results,” they write, “it is clear that psychedelics are not wonder drugs, but the hype has gotten ahead of the science.” They say that this is “reminiscent of what happened with medical cannabis”, whereby—in their interpretation, at least—“regulations pertaining to its medical use were approved, promoting a booming cannabis industry, despite lack of scientific evidence for its therapeutic efficacy.”
The National Institutes of Health (NIH), which oversees the work of agencies such as NIMH and NIDA, is funding over seventy active projects on the therapeutic use of psychedelics, the Viewpoint notes.
In terms of research priorities, the article highlights a handful of areas in which further research is warranted.
Unsurprisingly, given recent research and funding attention, evaluating the potential for non-hallucinogenic psychedelics is high up on the agenda. “An important research question is whether the subjective experiences associated with psychedelic drugs are intrinsic to or separable from their therapeutic effects”, they note.
While they acknowledge there is “evidence to suggest that psilocybin’s therapeutic efficacy is tied to the mystical-type experiences it commonly precipitates”, they then say that this connection “remains controversial”.
Alluding to research and development of psychoplastogens, they note that groups are “exploring whether desired (eg, depression-ameliorating) neuroplastic effects can be decoupled from the cognitive and sensory distortions that raise questions about the safety of psychedelic drugs.”
Next, the authors acknowledge the role of set and setting in psychedelic therapy, describing these contextual factors as playing a “significant role”. However, they note the lack of standard protocols for facilitation of psychedelic therapy and note that “there have been no rigorous tests” of whether a clinician’s “time and attention accounts for a nontrivial component of psychedelics’ therapeutic effects”.
Next, they survey some of the unique challenges faced by those running psychedelic trials. The first is perhaps the most obvious: administrative hurdles arising from psychedelics’ Schedule I status.
The second challenge identified by the authors is related to difficulties in finding adequate placebo controls. Again, no surprises here.
The authors suggest that greater “standardization and harmonized protocols for clinical trials are needed so that results can be compared, along with longer follow-up studies to understand long-term outcomes.”
Moving on to more commercialisation-related matters, the Viewpoint explains that a Risk Evaluation and Mitigation Strategy (REMS) will be needed in order to gain FDA approval before going on to discuss reimbursement. The authors go on to explain that “it will be helpful for regulators and payers to articulate the evidence required for drug approval and reimbursement determinations so that researchers can design responsive trials.”
On this topic, the authors later write that “[i]t is crucial that psychedelic-assisted treatments, if they become available, are available to everyone. That means they should be affordable.” Beyond the direct costs of the intervention that might be borne by a patient, they also point out that “given how time intensive the therapy may be, there should be accommodations for people with work, family, or transportation challenges.”
Further challenges for psychedelic research include the “baggage of past ethical transgressions, including egregious experimentation with LSD on unwitting study ‘participants’”. This recent history “places a unique burden on researchers to be transparent in their aims and methods”, the pair posit.
Because of this history, “people from racial and ethnic minoritized groups may be particularly hesitant to participate”; and yet, “inclusion of diverse study populations is necessary to ensure that findings are applicable across individuals with varying demographic characteristics.”
On the topic of patient vulnerability during the psychedelic experience, the Viewpoint explains that “the clinical staff’s role needs to be structured in ways that prevent possible abuses.”
“Answering the open questions and developing necessary structures will be a prerequisite to the eventual FDA approval, scaling-up, and reimbursement of these treatments”, the pair explain.
In an interesting admission, they go on to draw further parallels to cannabis. “Based on the experience with cannabis,” they write, “it is also likely that psychedelics will be used for therapeutic purposes even without FDA approvals and that if states legalize their use for medical purposes, there will also be an increased use for wellness or recreational purposes.” With this in mind, they argue that research “that informs about benefits and risks from such patterns of use will be necessary to guide public health policies.”
The short Viewpoint ends on a measured yet optimistic note. “Challenges notwithstanding, the promise of psychedelics research goes beyond the promise of new pharmacotherapies”, they pronounce.
Expanding on this point, they note that a “[b]etter understanding of the mechanisms by which psychedelics may increase resilience could be highly valuable.”
“Besides telling us about the neurobiology of resilience, such research might facilitate development of alternative treatment modalities (eg, neuromodulation) that could provide similar benefits for patients.”
(Our Editor Josh Hardman also covered the piece on Twitter.)
Video: Christian Angermayer in Conversation with Josh Hardman
Earlier this month, our Editor Josh Hardman hosted a fireside chat with psychedelics investor and entrepreneur Christian Angermayer at the British Museum as part of PSYCH Symposium. The video is now available.
(Non-bolded text is our summary and/or quick take.)
NYT – Minneapolis Mayor Loosens Enforcement of Psychedelics — Mayor Jacob Frey has signed an executive order effectively decriminalising certain psychedelics by making them the lowest law enforcement priority for local police.
Psychedelic Alpha Opinions – A Call for Clarity in Psychedelic Discourse — Jazz Glastra is Senior Director of Program Operations at BrainFutures, which just published its latest brief: Psychedelic Access Pathways. Here, Glastra delineates three distinct contexts in which psychedelics are regulated in the U.S. and proposes that we be mindful of these distinctions when discussing psychedelic use.
Nature Medicine – Psilocybin therapy for females with anorexia nervosa: a phase 1, open-label feasibility study — A Phase 1, open-label feasibility study of COMP360 psilocybin therapy in females with anorexia nervosa suggested that the intervention is “safe, tolerable and acceptable”. The study, which took place at UC San Diego, was published in Nature Medicine on July 24th.
STAT – White House unveils plan to make insurers cover mental health care — The Biden administration has unveiled a proposal to compel health insurers to cover mental health and addiction care to the same tune as physical health.
SPACs are Back? Filament Health Aims to List on NASDAQ Through Business Combination with Jupiter Acquisition Corp. — The proposed business combination would ascribe an equity value of $176m to Filament. An associated CAD $2m private placement financing was upsized to CAD $2.5m last week.
Bloomberg – The Psychedelics Stock Universe Is Shrinking, Despite the Hype — Tiffany Kary looks at how funding for psychedelic biotech has dried up and asks a couple of investors when the turning point may be.
Optimi Health – Optimi Health Announces Receipt of Purported Termination Notice — The Vancouver-based “drug researcher and formulator” has received a termination notice and demand for payment from a private mushroom-based drug developer, which alleges that Optimi failed to perform the obligations of a supply agreement.
Vox – Psychedelics might revolutionize therapy. What happens if you remove the trip? — Vox becomes the latest outlet to cover research around non-hallucinogenic psychedelics. “Just don’t call them psychedelics.”
Inverse – Psychedelic therapy may be coming to a VR headset near you — …and, Inverse becomes the latest outlet to cover VR-based trips.
Axios — Why mainstreaming psychedelics isn’t generating a fuss — Contrary to the “fiery debates” seen in the medical applications of marijuana, Axios argues that psychedelic research is subject to little pushback.
The Times – Crispin Blunt takes up the fight for magic mushrooms — The UK newspaper profiles conservative MP and former soldier, Crispin Blunt, who “says drug policy is blocking research into psychedelics as a treatment for depression”.
Daily Record – Veterans ‘failed’ by UK drug laws as SNP MP calls for magic mushrooms to treat PTSD — Blunt isn’t the only UK MP calling for psychedelic policy reform in a post-Brexit Britain.
Nature Scientific Reports – The difference between ‘placebo group’ and ‘placebo control’: a case study in psychedelic microdosing — Szigeti et al. introduce the Correct Guess Rate Curve, “a statistical tool that can estimate the outcome of a perfectly blinded trial based on data from an imperfectly blinded trial.” They apply this tool to their earlier self-blinding microdosing trial dataset and conclude that “microdosing can be understood as active placebo.”
Tampa Bay Times – St. Petersburg cannabis and psychedelics convention tests legal ‘gray area’ — According to this piece, vendors used “all sorts of legal loopholes” at St Petersburg’s first Cannadelic summer event.
ABC News – Australia legalises psychedelics to treat some mental health conditions, but therapists warn it is no miracle cure — Towards the end of this article, cognitive neuropsychologist and researcher at Swinburne University of Technology Prof Susan Rossell shares a little info about a trial of psilocybin for TRD: “The results of the pilot study show one-third of participants are doing well, one-third are doing really badly, and one-third have mixed experiences.”
CNBC (video) – Psychedelics in Silicon Valley: Founders looking for a creative edge — CNBC’s Kate Rooney looks at the use of psychedelics among techies, the pathway to FDA approval and how investors are looking at psychedelic companies.
Business Insider – Jaden Smith says he took magic mushrooms as a young adult. Brain experts who study psychedelics warn that wasn’t a good idea.
StarTribune – This veteran used psychedelics to treat his PTSD. Now he wants Minnesota to legalize it as medicine
CBC – Burlington woman with MS says police busts at magic mushroom stores limit access to vital medicine
Event: Cannabis & Psychedelics Investment Summit
Kahner Global’s 2023 Cannabis & Psychedelics Investment Summit will take place in New York City on November 16, 2023.
This is an invitation-only, day-long summit for family offices and ultra high net worth investors taking place November 16 in New York City. Attendees will discuss opportunities and exchange insights in an intimate setting revolving around the cannabis and psychedelics industries.
Breakfast, lunch, and a cocktail reception are included to further engagement and discussion alongside the educational panels highlighted throughout the day. The summit brings an exciting opportunity for intimate connections between founders and investors.
Those interested in attending can learn more and request an invitation via the website.
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