The efficacy of microdosing came under scrutiny this week, with a study co-authored by the likes of Robin Carhart-Harris, David Nutt and Amanda Feilding arguing that the “anecdotal benefits of microdosing can be explained by the placebo effect.” The research design was certainly interesting: 191 participants were asked to incorporate placebo control into their microdosing routine, however this was not supervised. Instead, the study was self-blinded, with participants instructed to place placebo and active capsules into envelopes with QR codes, before drawing the envelopes at random.
While this study is, of course, not comparable in rigour to an RCT, the authors claim that their novel self-blinding approach allows them to reach the following conclusion:
“…Our study validates the positive anecdotal reports about the psychological benefits of microdosing (significant improvements from baseline in a broad range of psychological measures); however, our results also suggest that these improvements are not due to the pharmacological action of microdosing, but are rather explained by the placebo effect (lack of significant between-groups differences).”
This is not the first research publication to raise questions regarding the practice of microdosing. While this study focuses on efficacy, other researchers have raised concerns regarding safety. The chronic administration of 5-HT2B agonists has been shown to carry some risks, as summarised on Twitter by Matthew W. Johnson:
“Many of us scientists responsible for the psychedelic research renaissance think there is realistic question about heart valve disease from chronic admin of microdoses. LSD, psilocybin, MDMA all agonize 5-HT2B receptors, a mechanism linked to valve disease.”
Several FDA-approved medications that rely on 5-HT2B agonism, such as fenfluramine/phentermine, have been withdrawn due to the risk of valvular heart disease. However, there is a dearth of longitudinal research on microdosing, and the doses involved are (unsurprisingly) small, so no firm conclusions can be drawn. Perhaps research by the likes of MindMed will give us a clearer picture of the safety profile of microdosing. In the meantime, those interested in this topic might wish to read Kelan Thomas’ article in Charcuna, published in December 2019.
Also under scrutiny this week is “the race to patent psychedelics” which, according to VICE, “is just getting started.” Shayla Love’s article explores the dizzying array of patents filed in relation to a number of psychedelics, including a number of patent applications covering DMT which were highlighted in our latest patent tracker resource.
This week has again demonstrated that a growing number of companies in the space are looking to investigate un(der)explored molecules and indications. This trend is particularly evident among smaller public companies, perhaps aware that later-stage clinical research being undertaken in popular molecules (e.g., psilocybin, MDMA, LSD) and indications (e.g., depression, anxiety, PTSD) is dominated by larger entities backed by significant funding (both for- and non-profit). As these popular areas of study and commercialisation become crowded, press releases increasingly focus on more diverse areas of purported R&D. This week, we learned that:
- PharmaTher plans to investigate neuromuscular diseases;
- Psyched Wellness is conducting preclinical trials of a Muscimol extract;
- Awakn is looking to expand its focus on the treatment of alcohol use disorder with the addition of ketamine;
- Algernon Pharmaceuticals is pressing on with its investigations of DMT for stroke;
- Silo Pharma is hoping to target rheumatoid arthritis using homing peptides as a delivery vehicle; and,
- Bright Minds Biosciences believes its proprietary 5-HT2C agonist will be effective in reducing binge eating.
Psychedelic Sector News
Atai Scoops $157m in Series D, $2bn Valuation
Atai Life Sciences announced the closing of a $157m Series D financing round this week, bringing the company’s valuation to $2bn. Peter Thiel and Christian Angermayer once again led this round, with a number of new investors entering the fray such as Michael Auerbach’s Subversive Capital.
The German company is expected to IPO as early as Q2, according to sources cited in Bloomberg’s coverage. Bloomberg also reported that Atai declined to comment on their valuation or their IPO plans.
Bright Minds’ 5-HT2C Agonists Show Reduced Binge Eating in Rats
According to Bright Minds Biosciences, their proprietary 5-HT2C agonists are effective at reducing binge eating in rodent models. Unlike many of the psychoactive compounds under investigation in this space, Bright Minds’ compound does not activate the 5-HT2A or 5-HT2B receptor.
The company explained that the observed reduction in binge eating among rats was comparable to the efficacy of Lorcaserin, a 5-HT2C agonist marketed under the name Belviq for weight-loss. Lorcaserin has not been available since the FDA requesting its withdrawal in February 2020 due to post-marketing trials revealing increased occurrences of cancer. The Agency noted, “we believe that the risks of lorcaserin outweigh its benefits based on our completed review.”
Bright Minds is presumably hoping that its proprietary 5-HT2C agonist will demonstrate a similarly efficacious, but far safer, alternative to Lorcaserin in humans studies. The task ahead (not just for Bright Minds, but for many companies engaged in preclinical work) is precisely this: to evaluate whether their findings in rodent models will be successfully replicated in human studies.
Numinus’ Licences Expanded to Include Ketamine and LSD
Numinus has received amendments to its federal licence to allow the possession, production, assembly, sale, export, and delivery of a range of psychedelics including ketamine and LSD. This development expands the work that Numinus can conduct, including the possibility of offering psychedelics testing among other services.
Numinus also provided an update on its Compassionate Access Trial which will evaluate psilocybin-assisted psychotherapy for substance use disorders. The trial will initially involve 30 participants. Having gone through two rounds of external peer review, the protocol is now finalized. The study, which is now in pre-implementation, will be conducted in collaboration with the contract research organization, Syreon Corporation.
Financials, Financings and IPOs
Atai’s Series D eclipsed all other financial news this week, which was otherwise relatively muted.
Atai Raises $157m in Series D
As mentioned above, Atai hit a $2bn valuation having raised a substantial Series D.
COMPASS Pathways Financial Results to be Announced March 9th
Investors can expect to review COMPASS Pathways’ Q4 and full-year 2020 financial results next Tuesday.
Novamind Q2 2021 Financials
Novamind reported their fiscal Q2 2021 results, showing $1.29m revenue primarily via their clinic offerings. The company reported a net loss of $3.6m for the 3 months ended Dec 31st, 2020.
Noetic Launches Second Psychedelic Investment Fund
Toronto-based Noetic has launched its second venture fund dedicated to investing in early-stage psychedelics and CNS-focused companies.
Silo Wellness Trades on CSE
Silo Wellness began trading on the CSE today, under ticker symbol SILO. The stock is not to be confused with Silo Pharma, which trades on the OTCQB under the same ticker symbol.
Experiential Psilocybin-assisted Therapy Training Program, Approved by Health Canada, Gets Underway
On Monday evening, a group of 15 Canadian healthcare professionals participated in the first session of a groundbreaking training program, hosted by nonprofit advocacy group TheraPsil.
The program, which spans ten weeks and will be led by clinical counselor Dave Phillips, is the first of its kind to commence in Canada. TheraPsil’s Founder, Dr. Bruce Tobin, explained that the launch of this program makes the country “a world leader in psychedelic medicine.”
Free Report: “IP & Patents for the Psychedelic Industry”
Microdose has today published their Special Report, which focuses on intellectual property in the psychedelics space. We contributed an article to this short report, which compares the role of IP in psychedelics to that of a number of comparable (to varying degrees) sectors such as biotech and pharma. Download a copy of the report here.
Sifted: “European Companies set to Dominate Psychedelics Market”
Through most of the 20th century, the piobneering research in the use of psychedelics to treat mental health disorders has largely come out of the US.
It was in California that psychiatrists such as Humphry Osmond in the 1950s began experimenting with giving patients the psychedelic drug LSD. The leading US nonprofit MAPS, which researches psychedelics, was born in the US in the 1980s.
But when it comes to the race to actually commercialise psychedelics, in order to treat disorders ranging from depression to addiction, the last 12 months have shown that European companies have become the clear leaders.
Read the full article, which was published just two days before German HQ’d Atai Life Sciences announced their $157m Series D round, at Sifted.
Stay Informed in 2021
We can only expect the rate of change and development in the psychedelic space to continue accelerating in 2021. Stay informed via our various platforms and channels…
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