Step by Cautious Step: Closing in on Psychedelic Drug Trials

Since opening its doors in 2019, Cybin, Inc., (NYSE: CYBN) based in Toronto, Ontario Canada has been on a mission to build a business in novel drug discovery (focusing on psilocybin and DMT), drug delivery systems, and treatment. 

It’s been on a fast track to make good on that mission. 

The company was the first psychedelics companies to be traded on the NYSE; it consistently makes business and stock watcher’s lists as one of the top psychedelics companies to watch; and it has 15 patent filings covering a wide range of novel psychedelic compounds from different classes, including targeted structural modifications to improve the drug pharmacokinetic characteristics and safety profiles without altering receptor binding.  “What we’ve been doing is very multi-dimensional,” Doug Drysdale, CEO of Cybin, told Green Market Report, referring to not only multi-faceted drug development but their Embark psychedelic facilitator training. “It’s not just about bringing a molecule to the clinic. We’ve been working to optimize these classical psychedelic molecules that we know a lot about, which are psilocybin and DMT. And we’ve been engineering them into different analogues and derivatives,” he said. “Ultimately, what we’re trying to do here is optimize the treatment for patients and for providers, because those are the hurdles you have to get through to have a successful product. It’s about optimizing the molecule to overcome some of the limitations, providing tools for therapists and providers, and then, at the same time, generating an IP to protect those investments.”

Drysdale said that there has been steady development work at Cybin to eventually get into human drug trials hopefully later in 2022, which is the next significant step in drug development.

As a pathway to get there, next month Drysdale and his team at Cybin are meeting with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care, which regulates medicines, medical devices and blood components for transfusion in the UK. They will also be submitting findings to the FDA in the next quarter. “We are taking a very much pharmaceutical approach, a very robust and sound scientific approach to in these meetings with both the MHRA and FDA,” he said.

There are a number of challenges working with a new substance like psilocybin, the least of which is building a business that requires a lot of capital upfront and months or even years of expensive drug development. Drysdale has seen what has happened to some of the early startups in this space. “I think a lot of those companies that went public were under-capitalized,” he said. “Now that the market has shifted a little bit, I think we’re going to see some companies facing challenges this year, maybe not having access to capital that they need. We’re also going to see, I think, the continued emergence of IP patents being issued, which will create opportunities for some and challenges for others. So there’s no doubt in my mind that we’ll see a lot of consolidation this year, and perhaps, you know, six or 12 months from now, there may not be 50 or 60 psychedelics companies, but maybe 10 to 20.”

Cybin has raised $120 million since 2019; expanded operations into Europe; and entered into exclusive research and development collaboration agreement with TMS NeuroHealth Centers, a company doing transcranial magnetic stimulation operating 129 outpatient mental health service centers in the United States.

Cybin is working now on investigating how to make psilocybin work better for the mental wellness effect it’s targeting, including exploring safer dosing amounts for patients. “We all metabolize differently,” Drysdale said. “So one patient versus another might have quite a different experience. One might have a profound experience, one might have a mild experience, and that creates an awful lot of variability. We’ve addressed that with our psilocybin, analog CYB003, to minimize that variability, with the goal of having more predictable outcomes. We know we’re dealing with psychiatry patients here, so we want to make sure that the responses are more predictable.” 

The other challenge with psilocybin is that it’s slow-acting, and patients may be in the clinic for an entire day. “When we speak to providers, that’s a real challenge in terms of the staffing and infrastructure,” he said. “So we have worked to accelerate the onset of action, and shorten the duration of action of our psilocybin analog so that the patient spends half the time that they would have spent in the clinic.”

Is he tracking the growing acceptance of psychedelics in the U.S. as demonstrated by the uptick in decriminalization efforts? “That wave of decriminalization is more of a criminal justice issue than a pharmaceutical issue,” he said. “But on the pharmaceutical side, both FDA and the MHRA in the UK and the DEA have all made moves in recent months that are positive. I don’t think the regulations and the scheduling are going to be the biggest hurdles to approval at this point. I think the train has left the station. I think we’re definitely past that point. And now it’s all about doing the science, the hard work of making these into pharmaceuticals.”

Dave Hodes

David Hodes is a business journalist based in the Washington D.C. metropolitan area. He has contributed feature articles to several cannabis and psychedelics publications, as well as general business/lifestyle publications, on a variety of topics. Hodes was selected as 2018 Journalist of the Year by Americans for Safe Access. He is a member of the National Press Club, and the deputy booking agent for the National Press Club Headliners Committee.

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