Psychedelic Bulletin: California Bill Aims to Decriminalize Psychedelics; MindMed Acquires HealthMode; and more…

Psychedelic Bulletin: California Bill Aims to Decriminalize Psychedelics; MindMed Acquires HealthMode; and more…

California’s Senator Scott Wiener has introduced an eagerly-anticipated bill that would decriminalize psychedelics in the state. California is the largest state in the U.S., with a population of approximately 40 million, making this an important bill to follow. Interestingly, the bill would not decriminalize mescaline, or the peyote cactus from which it is derived, due to its endangered status and the fact it is used in Native American spiritual practice.

As the interest in, and use of, psychedelics continues to grow, greater attention to sustainable supply is warranted, especially where it may threaten established uses in spiritual practice. Public figures like Hamilton Morris have drawn attention to the endangered nature of many plants and animals from which psychedelics are often extracted, such as the Sonoran Desert Toad (Bufo Alvarius), which secretes 5-MeO-DMT.

Elsewhere this week, MindMed announced their acquisition of HealthMode, a digital therapeutics startup, emblematic of an increasing trend toward investment in adjunct technologies. The company also announced the launch of their trip neutraliser study, which will seek to evaluate the efficacy of ketanserin in acting as an ’emergency off-switch’ during an LSD trip. The patentability and desirability of such a technology remains hotly debated.

In other acquisition news, Revive Therapeutics acquired PharmaTher’s psilocybin program, for which they will pay up to $10m. Numinus is moving ahead with its MDMA-assisted psychotherapy, in collaboration with MAPS PBC, and Tryp Therapeutics’ supplier has begun manufacturing a first batch of psilocybin.

Psychedelic Sector News

MindMed Acquires Digital Health Company; Begins Trip Neutralizer Study

Earlier this month we noted that MindMed appeared poised to make a tech platform acquisition. This week, that expectation was validated. MindMed is set to acquire HealthMode, a digital therapeutics startup that harnesses AI-enabled digital measurement technologies to augment clinical research and patient monitoring.

Through this acquisition, MindMed will gain access to HealthMode’s team of 24, their clinical drug trial platforms, as well as their IP. MindMed intends to integrate HealthMode’s tech and team into its own digital medicine division, dubbed Albert.

According to our editor-at-large, Graham Pechenik, HealthMode has one pending patent application, published December 2020. The application covers certain aspects of the company’s Pooply app, which allows users to track their bowel movements “discreetly and privately.”

MindMed to Issue ~$41m in Shares

In consideration of the acquisition, MindMed will issue HealthMode 82,508 multiple voting shares, which is equivalent to 8.25 million subordinate voting shares.

If we take the price of MMED at market close yesterday (17th February, 2021), these shares are valued at just over CAD $41 million. HealthMode will also receive approximately $300,000 in cash.

The acquisition is expected to close by the end of February.

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In other news from MindMed, this week we learned the company has commenced a study for its “LSD neutralizer technology,” which it hopes will be effective in shortening and even stopping the effects of an LSD trip during LSD assisted therapy sessions.

In collaboration with the Liechti Lab at University Hospital Basel, a Phase 1 clinical trial will evaluate the effect of ketanserin for this purpose. MindMed hopes the study will be completed by the end of 2021.

Ketanserin: a 5-HT2A Antagonist

LSD is a serotonergic (or, ‘classic’) psychedelic, which binds to the 5-HT2A receptor. As such, it is understood to be a 5-HT2A agonist.

Ketanserin, meanwhile, is a 5-HT2A antagonist, and has been shown to remove most of the acute effects of LSD if administered prior to the administration of LSD (one such trial was conducted at University Hospital Basel itself; see also Section 6 of Canal, 2019 and Preller et al., 2017 for further information on Ketanserin and LSD).

Now, MindMed seeks to go beyond this pretreatment effect of ketanserin and explore whether the same effect can be reproduced after LSD has already been administered, to see if ketanserin can still mitigate the subjective effects of LSD when the psychedelic experience is in full swing.

Ketanserin itself with discovered by Janssen Pharmaceuticals (owned by J&J) in 1980. However, MindMed hopes that this study will support its patent application filed in 2020 which intends to cover its application as a neutralizer technology during LSD therapy.

Possible, patentable, profitable?

Whether this application of ketanserin will be effective, patentable, and profitable is yet to be seen.

Psychedelics researcher Matt Baggott points out that “stopping an LSD trip with a 5-HT2AR antagonist might be harder than stopping trips from other psychedelics.” Baggott goes onto explain, “when LSD binds to 5-HT2AR, it seems to pull part of the receptor down, forming a lid.” While this may help to explain the length of an LSD trip, it could also make ketanserin posttreatment ineffective.

A broader discussion that this technology touches upon is whether a bad trip is something to be mitigated or confronted. For an interesting cultural history of the ‘bad trip,’ Erika Dyck and Chris Elcock’s article in The Social History of Alcohol and Drugs is worth a read.

It is also yet to be seen whether patent examiners will deem this a novel technology. 

Revive Therapeutics Acquires PharmaTher’s Psilocybin Program

PharmaTher has sold its psilocybin program to Revive Therapeutics, which will pay up to CAD $10m for the assets. Revive will acquire all IP derived from PharmaTher’s pre-clinical research work related to the investigation of psilocybin in TBI and stroke. 

Through the deal, Revive also gains ownership of a number of provisional patent applications, which cover:

i) psilocybin in the treatment of neurological brain injury;
ii) psilocybin in the treatment of cancer; and,
iii) psilocybin pharmaceutical combination therapies.

Numinus Moves Ahead with MDMA Trial

Numinus has shared an update on its MDMA-assisted therapy for PTSD trial, which is being pursued in collaboration with MAPS Public Benefit Corp.

Following the successful completion of a number of milestones – including the recruitment of therapists, physicians, and staff – the trial has advanced to the pre-implementation stage at the company’s Vancouver clinic.

Initial meetings with Health Canada have been undertaken, in which the trial’s implementation science strategy was defined. Now, Numinus and MAPS PBC will seek to obtain ethical and Health Canada approvals to enable them to move toward the recruitment of participants.

AMRI Begins Manufacture of Psilocybin for Tryp

Albany Molecular Research has begun the process of manufacturing a 200g demonstration batch of psilocybin for Tryp Therapeutics. According to Tryp. this is the first step in the company’s plan to manufacture batches of their proprietary formulation of cGMP psilocybin, TRP-8802.

Champignon Inches Closer to Re-Listing

Champignon Brands, which has been subject to a review by the BC Securities Commission for quite some time, appears to be inching closer to a re-listing. The company announced that it is restating certain filings, including financial statements. Champignon has also filed a draft new Listing Statement with the Commission and the CSE for review.

Financials, Financings and IPOs

This week we saw Mydecine close a $17.25m round, and Psyched Wellness secure $6.6m. We also had a chance to review Field Trip’s latest financials.

Field Trip Reports Q3 2021 Financials

Field Trip shared their Q3 2021 financials, including key highlights and developments. 

Mydecine Closes $17.25m Round

Mydecine closed a $17.25m bought deal offering, with units priced at $0.50 each.

Psyched Wellness Closes $6.6m Round

Psyched closed a bought deal offering of 21.3m units priced at $0.31 each, for gross proceeds of $6.6m.

Weekend Reading

California Bill Aims to Decriminalise Psychedelics

Yesterday, San Francisco’s Sen. Scott Wiener introduced a bill that would decriminalise psychedelics, and expunge criminal records for people with prior convictions related to possession.

Notably, the bill explicitly excludes peyote, and as such both peyote and mescaline will remain illegal in the state. The reasoning for this exclusion is to ensure that the endangered plant remains available for use in Native American spiritual practices.

Read the official release from Sen. Scott Wiener’s office, or the coverage on NBC News.

Psychedelics Research Review: January 2021

2021 is off to a strong start in terms of psychedelics research, with plenty of insightful papers published in January.

An RCT of repeated ketamine administration for PTSD found that, among those who responded to the drug, the median time to loss of response was less than a month (27.5 days). Ketamine was also studied in the context of treatment-resistant depression (TRD). 23 adults suffering from TRD underwent a four-day (96 hours) infusion of ketamine, which provided a “tolerated, rapid, and sustained response” to TRD.

Elsewhere, a meta-analysis of 12 studies that pitted serotonergic psychedelics against mood disorders concluded:

“Despite the concerns over unblinding and expectancy, the strength of the effect sizes, fast onset, and enduring therapeutic effects of these psychotherapeutic agents encourage further double-blind, placebo-controlled clinical trials assessing them for management of negative mood and depressive symptoms.”

There’s plenty more psychedelics research to explore this month. In our endeavour to provide you with the data necessary to track and analyse the emergent psychedelic sector, we’re working with Blossom Analysis to bring you a monthly research round-up.

Visit the review here.

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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