In our 2020 Year in Review, we predicted that technology and digital therapeutics would play an increasingly important role in the work of psychedelics companies: from augmenting drug discovery by employing AI, right through to empowering end-users of psychedelic therapies and medicines by providing personalised treatment regimes and actionable insights through the use of wearables.
This week has seen a clear focus on such adjunct technologies and devices…
Cybin led the news on this front by announcing their partnership with LA-based Kernel, which produces a non-invasive neuroimaging device dubbed Flow. Cybin hopes to receive the devices in Q2, after which it plans to use Flow data from sponsored studies to inform their future work.
In a similar vein (i.e., through the use of ‘wearables’ of sorts), MindMed confirmed that their recently formed Albertdigital therapeutics division will employ digital tracking devices and software to better understand LSD’s effects on a variety of clinical markers. The data will be collected as part of a randomised, placebo-controlled study to evaluate the effects of microdosing LSD, announced earlier this week.
Mind Cure, meanwhile, is seeking to gather real-world data for its iSTRYM (pronounced ‘eye stream’) digital therapeutic tool. The tool employs AI to collate users’ inputs and generate actionable insights, which Mind Cure hopes to use to augment clinicians’ diagnoses and treatment plans. This week, the company announced its intent to make a strategic investment in ATMA Journey Centers, a Canadian psychedelic therapy provider. This should allow Mind Cure to collect organic data to improve iSTRYM’s model.
Finally, Entheon has made an investment in an adjunct technology via its acquisition of HaluGen, which is developing a pre-screening test that it claims identifies genetic markers that can help predict an individual’s reaction to hallucinogens. If effective, HaluGen’s test could be a useful tool in deciding which (or, whether) psychedelic therapies are appropriate for patients on an individual basis.
These four announcements, while diverse in nature, all speak to the employment of adjunct technologies to augment psychedelic science and the ultimate delivery of psychedelic-based medicines and therapies. Entheon and Mind Cure’s announcements, in particular, relate more to the personalisation of care delivery, while Cybin’s partnership with Kernel appears set to focus on the development of new molecules and associated clinical programs.
Beyond this trend, the week saw a steady flow of company news and mainstream media pieces on psychedelics, which have become something of a benchmark as we enter the new year. Notably, UFC President Dana White had one of his team reach out to Johns Hopkins to discuss the potential for psychedelics to be used in the treatment of mental health illnesses and traumatic brain injury. Also, Somerville, MA, became the latest U.S. city to decriminalise psychedelics in a unanimous (9-0) vote.
Psychedelic Sector News
MindMed Adds Robert Barrow as Chief Development Officer; Announces LSD Microdosing Study
Robert Barrow is joining MindMed as Chief Development Officer. Barrow previously served as Director of Drug Development & Discovery at the Usona Institute.
During his time at Usona, Barrow was responsible for the launch of their Phase II clinical program for psilocybin in the treatment of Major Depressive Disorder (MDD), for which the nonprofit received a Breakthrough Therapy Designation from the FDA.
Earlier in the week, MindMed announced a randomised, placebo-controlled study to evaluate the effects of microdosing LSD on: cognitive performance, sleep quality, mood, neuroplasticity, emotion regulation, quality of life, and immune system response.
The study will be conducted in collaboration with Maastricht University’s Dr. Kim Kuypers, and will be integrated into MindMed’s newly-formed Albert digital therapeutics division. Specifically, digital tracking devices and software will be utilised to better understand LSD’s effects on various clinical markers; as aforementioned.
Additionally, the Company’s Microdosing Division is undertaking a Phase 2a clinical trial evaluating microdoses of LSD for ADHD.
Cybin Partners with Kernel to Harness Neuroimaging Tech
Cybin is partnering with LA-based Kernel, which has a focus on quantifying the human mind, such as via non-invasive neuroimaging systems. Their Flow device is one such product. Worn on the head, the device is able (via near-infrared spectroscopy) to determine how oxygenated the wearer’s blood is at any given time. Such measurements can be used as proxies of neural activity during a psychedelic experience, for example.
Kernel has raised $104m to date, including investment from prominent VC firms General Catalyst and Khosla Ventures. The company’s founder, Bryan Johnson, formerly founded and led Braintree Venmo (now a household name in the U.S.), which was acquired by eBay for $800m in 2013.
Tryp Therapeutics Adds to Board of Directors
Tryp Therapeutics has appointed Gregory M. McKee to its board of directors. Commenting on the appointment, Tryp’s Executive Chairman William Garner, M.D. said “Greg’s deep understanding of the biotechnology industry and capital markets is invaluable as we elevate Tryp to the next stage in its development.”
Champignon Annonces New CFO, General Counsel
As part of a broader management shake-up, Champignon has appointed a new CFO and General Counsel. In December, the company appointed an interim CFO, Chris Hobbs, who worked on the company’s response to the British Columbia Securities Commission’s continuous disclosure review and cease trade order, still in effect. Hobbs will now act as special advisor to Champignon’s new CFO, Stephen R. Brooks, advising him with regard to the ongoing review.
Mind Cure to Acquire Ownership Interest in ATMA, Psychedelic Treatment Centre
Mind Cure looks set to make a strategic investment in ATMA Journey Centers, which provided access to psychedelic-assisted psychotherapy for an Alberta resident under a Section 56 exemption announced by SYNTAC Institute last week. The proposed investment would see ATMA use Mind Cure’s psychedelic drug protocols and iSTRYM proprietary digital therapeutics platform to optimize treatment. In turn, ATMA would provide vital data for the development of iSTRYM‘s AI (as mentioned earlier).
CBDV Begins Researching Psilocybin via Sec 56 Exemption
Complex Biotech Discovery Ventures (CBDV), based at the University of British Columbia in Vancouver, has begun researching psilocybin via a Section 56 exemption from Health Canada. In December 2020, Havn Life signed a contract with CBDV to analyse various psilocybin extraction methods.
Entheon Acquires HaluGen
Entheon Biomedical has acquired HaluGen, a biotech company developing a pre-screening test which it claims identifies genetic markers that can help predict an individual’s reaction to hallucinogens. In consideration of the transaction, Entheon issued 5m shares to HaluGen shareholders, worth just under $4.5 million at close on Jan 14th.
Financings and IPOs
It’s been a quieter week in terms of financings with just a couple of announcements to report…
Mydecine Announces $10m Bought Deal
Canaccord Genuity has agreed to purchase 20m units of the company, at $0.50 per unit.
PharmaTher Trades on OTCQB
PharmaTher (a subsidiary of Newscope Capital Corp.) commenced trading on the OTCQB Venture Market on Wednesday, January 13th.
New Resource: Psychedelics Glossary
This week we launched our latest public education resource: a glossary of terms you may come across in the psychedelic space, including relevant regulatory and clinical trial terminology.
Suggestions are welcome and can be submitted via the form at the top of the page.
Somerville, MA, Becomes Latest City to Decriminalise Psychedelics
DoubleBlind reported that the Somerville City Council unanimously (9-0) voted to decriminalise the possession of entheogenic plants this week. Somerville, with a population just north of 80,000, joins other U.S. cities such as Oakland, Santa Cruz, and Ann Arbor; all of which have voted for similar measures.
UFC Reaches out to Johns Hopkins Regarding Psychedelics for Traumatic Brain Injury
A number of outlets picked up on this story, in which UFC President Dana White instructed Jeff Novitzky, Senior VP of Health and Performance, to look into psychedelics for traumatic brain injury. Talking to ESPN, Novitzky said: “Dana said, ‘Hey, find out what this is about, […] see if it does help with some traumatic brain injury, addiction, mental-health problems. We want to be on board and we want to be first.”
It appears that HBO’s Real Sports coverage of psychedelics late last year spurred interest among the upper echelons of UFC.
Disclaimer: Although research has suggested high doses of psychedelics are relatively safe, there has been no specific published research to date on the long-term effects on health and safety of microdosing (1).
What is microdosing and why microdose?
Microdosing is consuming a small amount of a psychedelic drug (usually one-tenth to one-twentieth of a standard dose). Unlike with a full psychedelic dose where there is a marked alteration in cognition and perception, taking a microdose elicits a minimal identifiable effect.
The motives for microdosing are commonly to stimulate productivity, increase focus, energy levels and creativity and induce positive mood. Some microdosers also use microdosing as a way to help combat symptoms of nervous system problems including depression, anxiety and pain (2).
Deciding whether or not to microdose
Microdosing may not suit everybody, and the positive benefits some people may report may not be felt by other individuals. Although many of the anecdotal reports for microdosing published suggest positive effects, there have also been reports where microdosing has had an unpleasant effect on the individual’s life (3). It is important to weigh up the pros and cons of microdosing before making a decision.
This chart from the Harm Reduction Journal identified benefits and challenged generated through a wide-scale participant survey of microdosers: (4)
As with all psychedelic experiences, intention plays an important role. Deciding why you would like to microdose and what you hope to achieve from microdosing will help tailor your experience and increase the likelihood of you being able to use microdosing to an advantage.
Choosing which drug to microdose
The most commonly microdosed psychedelics are LSD and psilocybin (1). However, other microdosed drugs include DMT, marijuana, mescaline, 4-ACO-DMT, ibogaine, 2-CB and 1P-LSD (4). Microdosing different drugs will elicit different effects so reading personal experiences for different drugs, for example on Reddit, will help inform which the best drug to microdose is for you. The author of this article investigates microdosing four different types of psychedelics and gives his review on each: Although researching how different drugs may have different effects, all anecdotal reports will be influenced by personality and individual differences and so effects in one person may not translate into another. Experimenting trying different drugs for microdosing and journaling the experience yourself is the best way to work out which drug is right for you.
Weighing up microdoses
Generally microdoses are between one-tenth to one-twentieth of a regular dose. For example, a recreational dosage of LSD is between 100-200ug, therefore a microdose is commonly 10-20ug. When dosing drugs it is always better to start off with a smaller amount and then decide to increase the dose by a small increment if desired. For example, taking 5ug of LSD to begin and then increasing the amount to 10ug if you would like to experience a larger effect. If microdosing LSD, 1P-LSD or any drug that comes in form of a tab which has been blotted, it is recommended to first dissolve the tab in a known amount of distilled water or alcohol then having a measured volume at a time. For example, if dissolving a 100ug tab of LSD in 100ml of distilled water will mean having a 1ml drop will equate to 10ug. There may be an uneven distribution when drugs are blotted onto tabs so using this volumetric method gives a much more precise way of measuring microdoses and not accidentally consuming too much unintentionally. If microdosing psilocybin mushrooms, as there is an uneven distribution of the psychoactive material throughout the fungal structure, it is recommended to first grind the mushrooms into a powder and then weigh up the doses. It is important to be aware that different species of mushrooms have different potencies, a guide to the estimated percentage psychoactive constituents for different psilocybin mushroom species can be found here. Microdosing protocol
The most common protocol for scheduling microdosing is by having one day “on” (taking the microdose) followed by three days “off” (5). The idea behind this method is that the microdose will have residual effects for up to two days afterwards and by spacing out the doses this helps prevent tolerance occuring (where desensitisation to the drug means more of the substance is required to elicit the same effect). Although this is a common protocol, there are no set rules about how to best microdose and experiences are different for different individuals. For example, Paul Staments the famous mycologist, recommends a protocol of five days on, two days off when microdosing psilocybin mushrooms. The best way to find out what protocol works for you is to try different methods and keep a journal to record your experience. As psychedelics have stimulant effects, it is recommended to take the microdose in the morning as this decreases likelihood of sleep disruption as a result.
Potential risks As no research has been carried out looking at long-term health consequences of microdosing, potential risks are unknown. A chart showing interactions of psychoactive drugs with various psychedelics and other psychoactive drugs with prescription medications can be found here. Although this applies to large doses of psychedelics, similar contraindications may apply for long-term use of microdosing. One study found that microdosing caused an increase in neuroticism (1). As neuroticism is a trait in psychiatric disorders, there is potential that people diagnosed with things like bipolar and schizophrenia disorder may find that microdosing worsens their symptoms. Furthermore, those with a rich family history of mental health problems or suffering from mental health problems are advised not to take psychedelics as the drugs may act as an environmental stressor and trigger symptoms. Although this guidance is for large doses of psychedelics, an accumulative effect of small doses may have a similar effect.