Will psychedelics cure depression? 🍄
The Renaissance opening the pandora’s box...
Hello and welcome to Careviser by Marie Loubiere, the weekly newsletter that cuts through the healthcare noise with a single focus: productization of the latest research and tech breakthroughs.
Since the Johns Hopkins University School of Medicine launched a research group on psychedelics potential for psychiatry in 2000, psychedelics have become the new darling of investors. Several biotechs in the space have IPO’ed, and the first psychedelics ETF launched earlier this month.
Psychedelics in Psychiatry—Keeping the Renaissance From Going Off the Rails by Yaden DB, Yaden ME and Griffiths RR.
🗝️ Why it matters: since the early 00s, research on psychedelics has experienced a renaissance. Some studies have shown that psychedelics could cure psychiatric conditions. This period can be compared to the last time researchers were bullish on psychedelics in the 50s and 60s. It ended in drama as research on psychedelics was prohibited in 1971 in the US due to discutable medical practices, a lot of utopia not grounded in facts, but also stigma from the media.
🚫 Operational challenges: due to the prohibition, it was close to impossible to source medical-grade psychedelics for research studies.
🔎 Current trends in research: Researchers are interested in psilocybin (a compound found in mushrooms), mescaline, DMT and LSD. Research from the past twenty years shows that some psychedelics can lift patients' moods, and decrease anxiety symptoms. It could also be helpful for substance abuse disorders. When used in a controlled environment, it seems that psychedelics show low toxicity and addiction potential.
🙅♂️ Potential limits: Research on the potential of psychedelics is limited but has already generated a lot of interest from patients.
There is the risk that again some people may be tempted to already use it even if benefits aren’t fully clear yet.
Lack of trust in clinical trial data as clinical studies are not completely double-blinded: participants can easily tell whether they received a placebo or the real thing.
About one in ten Americans take antidepressants. And it doesn’t work as shown by the mental health crisis most of western countries are now facing. The market for new psychiatric treatments is huge and growing. However psychedelics companies will face many issues before they can scale:
🧾 Regulatory: Psychedelics will have to be legalized by medical regulators, but also they need to be declassified as a banned substance in most countries. In the US, the FDA has designated MDMA and psilocybin, as “breakthrough therapies.” for some applications. It means that they could be cleared faster if clinical trials show positive results.
This is a route that was used by Janssen who received approval for Spravato, a Ketamine-based nasal spray in 2019. The intended use is only treatment-resistant depression and it is administered in a controlled clinical setting (the patient has to stay at the facility for two hours after the treatment). It was considered the first ever psychedelic drug to be approved by the FDA (even if chemically Ketamine isn’t really a psychedelic). However it was rejected by the NHS in 2020 citing insufficient efficacy data and high treatment cost.
Quite a few biotech companies have gone public in the past two years and are focused on going through clinical trials: Cybin, Entheogenix Biosciences (which is a spin-off from Atai Lifesciences), Mindmed, Revive Therapeutics and Compass Pathways.
There are 27 studies for psilocybin currently active or recruiting in the US in Phase II...and none in Phase III meaning that it will take several years before it can be marketed in the US.
At the end of 2020, Oregon became the first US state to legalize psilocybin. So far, it is only available in qualified therapeutic settings with the oversight of a professional. It opens the way for alternative local market access even before FDA approval.
💸 Reimbursement strategies: even if psychedelics were to be approved by drug regulators, biotech companies would need to get their drugs reimbursed by payers. They will have to overcome the usual obstacles that come with marketing a novel medicine and will also face additional hurdles due to the stigma of psychedelics and their recreational uses.
A few startups have decided to by-pass reimbursement pathways and go Direct-to-Consumer. In that case, they are more focused on wellness benefits of psychedelics than on treatment of mental health diseases such as depression, similarly to what happened with CBD. Neon Mind markets mushroom-infused coffee. They went public a few weeks ago.
Silo Wellness, started by a team who was active in the cannabis space, just launched last year with a mushroom-based nasal spray.
🥼 New clinical pathways: psychedelics, even when microdosed, have a strong impact on patients’ mind. Once they are approved as medicine, new clinical pathways will have to be defined: what dosage to be administered to what type of patient, when, at what frequency… Most likely, they will be administered in a clinical setting under the supervision of a health provider. Psychedelics can alter perception of reality meaning that the provider will have to take care of the patient for hours. There is also the need to schedule follow-up sessions to deconstruct what the patient experienced. So far, a lot of the biotechs active in that space don’t seem to be that focused on innovating in terms of clinical workflows, even if they will be crucial for adoption.
Field Trip Ventures is an interesting startup. Founded in 2019, they already have six four clinics in the U.S., Canada and the Netherlands that administer ketamine therapy. They went public last year through a reverse take-over. They will use these learnings to model how psilocybin therapy will be administered once legal.
We're really using these centers as innovation hubs, so that we can start to understand all the dynamics of setting — the music, the lighting, the aesthetics of a clinic, what therapy protocols are most effective, which molecules.
Field Trip Ventures is also investigating the supply side of psychedelics as they are building a mushroom cultivation facility in Jamaica.
Also started in 2019, Nana Heals is based in L.A. and also aims to open “transformative medicine” clinics.
👩⚕️ Training of therapists: psychedelics have been stigmatized for decades. Therapists will need to be trained to administer psychedelics clinical treatments. Screening processes will need to be developed to make sure that therapists are unbiased. I see a lot of potential for startups to develop training and vetting solutions in that space.
🤑 Profitability: Psychedelics induced trips will take a least one hour. Then patients will need to meet their therapists to wrap up their learnings. This can take a lot of time, and there will be a need to streamline both the treatments and all the workflows to make sure that it is a profitable treatment for clinics.
📈 Tracking of outcomes / side-effects: Psychedelics administration will be pretty new when drugs reach Phase IV. More than ever, side-effects will need to be monitored by drugs vendors, but also patients screened accordingly with risk calculators.
🍄 Sourcing and manufacturing of ingredients: as psychedelics have been banned for decades, it is very hard for researchers to access clean vetted ingredients for clinical trials and research. Such shortage will become even more acute when they become legal. Ingredients suppliers will be needed. Anahit Therapeutics is already positioned in that space. They are building a psilocybin cultivation farm in Jamaica, and they hope to supply pharmaceutical firms.
That’s a wrap for today! Don’t hesitate to reply to this email with comments, I read and answer all emails :)