You are currently viewing Psychedelic Bulletin: Proliferation of Psilocybin-Related Drug Development; Biden-Harris Administration Aims to Reduce Barriers to Schedule I Research

Psychedelic Bulletin: Proliferation of Psilocybin-Related Drug Development; Biden-Harris Administration Aims to Reduce Barriers to Schedule I Research

In previous bulletins, we have discussed how the psychedelic drug development landscape is becoming increasingly crowded across all major delineations (primarily molecule / indication). In February we looked at DMT, which we covered more deeply in a July edition. On the indication side, we touched on alcohol use disorder in a late-April dispatch.

Out of fear of stating the obvious, we haven’t drawn a great deal of attention to just how crowded the for-profit psilocybin (and analogs) research space is. A sampling of company announcements this week provide an opportune moment to make that point.

Psychedelic Sector News

The following four companies each made announcements of psilocybin-related research programs this week. Let’s explore them briefly, in turn…


Mydecine Targets Smoking Cessation

On Tuesday, Mydecine announced that it has partnered with Dr. Matthew Johnson at Johns Hopkins on a study evaluating MYC-001 combined with a smoking cessation program.

According to Mydecine, MYCO-001 is “99.9% pure” psilocybin derived from natural fungal sources. The company hopes to launch the trial by January 2022.

The study is grounded in earlier findings from a 2014 study by Johnson and colleagues, who found that psilocybin-assisted smoking cessation led to a 67% abstinence rate at twelve months (n=15). The centre is currently conducting a larger study comparing the efficacy of a nicotine patch with cognitive therapy to psilocybin with cognitive therapy with the same goal of augmenting smoking cessation.

In the press release, Mydecine explained that they hope to utilise a seamless Phase 2/3 clinical trial design, which they explain as “combining two or more phases into one study.” These adaptive clinical trials allow for changes to the trial after its initiation, making them more flexible and – ideally – efficient (see Mahajan and Gupta, 2010). Speed is clearly of interest to Mydecine, which claimed that this study “could be completed as early as Q4 2022.” 

Seamless trial design is accepted as being appropriate for some drug development programs, and has primarily been employed in the development of oncology drugs. While former FDA commissioner Scott Gottlieb did announce in 2017 that he sought to expand the use of seamless trials beyond oncology to reduce drug development costs, the scope was still largely limited to immunology and targeting specific molecular deficits.

Seamless trial design also raises issues with regard to statistical analysis and validity, as the adaptive process introduces bias into the process. For a more detailed explanation of the statistical complexities surrounding these trial designs, see this piece by Elaine Eisenbeisz.

The seamless design, somewhat iterative in nature, can also lead to a lack of interaction with the FDA in the midst of important changes to the trial design or cohort. As such, FDA representatives have previously suggested that it might best be reserved for drugs that are granted breakthrough therapy designations, as this designation increases interaction between the FDA and the sponsor.

Mydecine’s trial design has not yet been published.

As an aside, the company’s press release contained a misleading (at best) statement regarding varenicline (Chantix, Champix), a prescription medication used to assist smoking cessation. The press release reads:

“Until it was recalled in July 2021, one of the most successful smoking cessations treatments was varenicline, or Chantix. Sales for Chantix reached $1.1B in 2020 despite the potential harmful side effects. Although a wide variety of treatments exist, tobacco addiction continues to remain largely untreated.”

The recall Mydecine cites concerned twelve lots of Chantix, a brand of the generic drug varenicline. It did not entail the removal of varenicline from the market. In fact, the very source linked to in the press release explains this clearly.


Nova Mentis Targets ‘Diabesity’

Nova Mentis, meanwhile, announced earlier this week that it is expanding its psilocybin research program to target obesity and diabetes (or, ‘diabesity’). The company explained that, through the course of preclinical study of psilocybin treatment in rats with symptoms of autism spectrum disorders, researchers discovered additional findings regarding inflammatory cytokines and chemokines. The company believes that these additional findings suggest that Nova Mentis’ psilocybin formulation has potential in the treatment of diabetes and obesity.

In the press release, Nova Mentis invokes scientific studies that suggest the role of 5-HT2C in the regulation of body weight and food intake. The company then notes that 5-HT2C agonist lorcaserin was approved by the FDA for the treatment of obesity.

We commented on lorcaserin earlier this year with regards to Bright Minds Biosciences’ proprietary 5-HT2C agonists, which the company presumably hopes will demonstrate a similarly efficacious, but far safer, alternative to lorcaserin, which was pulled by the FDA 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.”

Importantly, Bright Minds’ compound does not activate the 5-HT2A or 5-HT2B receptor, whereas Nova Mentis’ “psilocybin formulation” presumably does.


Field Trip Targets TRD and Postpartum Depression

Yesterday, Field Trip announced that it will pursue Treatment Resistant Depression (TRD) and Postpartum Depression (PPD) as its lead indications for FT-104, its novel psychedelic compound that it claims has a similar 5-HT2A potency to psilocybin, but with a shorter duration. While this isn’t necessarily a psilocybin analogue, we have included it here.

In terms of PPD, Field Trip CEO Joseph del Moral explained: “Notably, PPD is an acute condition with a lower regulatory burden and shorter overall timelines for approval making FT-104 a potential first-in-class for PPD. By pursuing TRD and PPD in parallel, we can achieve both speed and scale for FT-104.”

The company hopes to commence Phase I clinical trials in Q1 2022.

Clinical research concerning the safety of taking psychedelic drugs while breastfeeding is virtually non-existent. We do know that most drugs ingested by the mother make their way into breast milk, however the dose received by a baby is usually very small, and risk can potentially be mitigated by waiting for a multiple of half-lives since the drug was first ingested.


Mindset Pharma Targets TRD and End of Life Cancer Angst

Shortly after Field Trip’s announcement, Mindset Pharma revealed that it has selected TRD and ‘end of life cancer angst’ as indications for its novel psilocybin-inspired candidate, MSP-1014. As readers are aware, Treatment-Resistant Depression is the indication pursued by Compass Pathways. “End of life angst,” meanwhile, is not a generally accepted indication.


Other Headlines

Read more on our News page.


Weekend Reading

Biden-Harris Administration Recommends Reducing Barriers to Scientific Research For All Schedule I Substances

In a press release published last week, the White House explained that Regina LaBelle, Acting Director of National Drug Control Policy, has presented to Congress the Biden-Harris Administration’s recommendations that primarily relate to reducing the supply and availability of illicitly manufactured fentanyl-related substances (FRS).

Beyond recommendations related to FRS, the piece explains the Administration’s ambition to “establish a simplified process that would align research registration for all Schedule I substances […] more closely with the research registration process for Schedule II substances.”

The press release goes on to explain that, “the Biden-Harris Administration strongly supports expanding the research of Schedule I substances to help advance evidence-based public policy.”

Given that psychedelics are Schedule I substances in the United States, these recommendations to Congress could make research into psychedelics such as psilocybin and DMT more straightforward than at present.


Inverse: What does ketamine do to your brain?

This piece in Inverse looks at how ketamine works on the brain at both the micro and macro scale, compares it to propofol, and explores how the drug can be used to treat depression. This is the latest in a number of articles published in Inverse on the broad topic of psychedelic medicine.


Mount Sinai’s Center for Psychedelic Psychotherapy and Trauma Research Bags $5m Grant

“A major bottleneck in the emerging field of psychedelics is in the training and education of therapists in community-based settings such as the VA,” said Rachel Yehuda, PhD, Director of the Center for Psychedelic Psychotherapy and Trauma Research. “The gift from The Bob & Renee Parsons Foundation allows us to leverage the knowledge obtained in our clinical trials at the VA and Mount Sinai towards training a diverse group of therapists with expertise in treating PTSD in real-world clinical settings.”

Read more at Mount Sinai.


Seattle is now in the process of legalizing psychedelics

The process of decriminalizing psychedelics has actually been in the works for a while. On June 8th, 2021, 7 out of 9 Seattle City Council Members signed a letter to investigate the potential benefits of psychedelics for therapeutic uses. The state’s Overdose Emergency and Innovative Recovery (OEIR) responded with a recommendation to decriminalize psychedelic substances at the state level.

Read more at Curiocity.


Currently, Health Canada has only approved psilocybin treatment for people in palliative care. However, a growing number of private companies (startups such as Numinus Wellness, Doseology Sciences and HAVN Life Sciences, all in British Columbia) and academic institutions (University of Toronto and University of British Columbia) are trying to convince government regulators that more money and time should be invested in researching how psilocybin-assisted psychotherapy might be used to unlock some of the mysteries of the human brain.

Read more at The Globe and Mail.

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