Psychedelic Capital: Clinical Trials and Going Mainstream - Truffle Report
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Psychedelic Capital: Clinical Trials and Going Mainstream

Psychedelic Capital: Clinical Trials and Going Mainstream

Psychedelic Capital Conference Stock Image
  • Microdose’s Psychedelic Capital event was held on April 29
  • The virtual conference included panel discussions on the clinical trials, real-world evidence (RWE), and government policies for drugs
  • Panellists shared company presentations and investment opportunities in the emerging sector

Microdose’s virtual Psychedelic Capital event took place on April 29. Produced by Microdose, the conference has brought together leaders in the psychedelics space to share their insights on investing and key market trends.

BetterLife Pharma

BetterLife Pharma is a life science company focused on the development of pharmaceutical-grade products and drug delivery mechanisms for clinical trials and commercialization. The panel featured Ahmad Doroudian, CEO of BetterLife Pharmaceuticals, Patrick Kroupa, Chief Psychedelic Officer, and Justin Kirkland, Head of Psychedelic Chemistry and Synthesis.

“I have a very long history working with psychedelics that spans decades. It’s a bit over 20 years for me, and they have profoundly impacted my own life and my own evolution. It is incredibly exciting to be here now in this moment within time, where psychedelics are being mainstreamed, and benefits of these different molecules are going to be reaching a much broader audience of human beings who need them,” said Kroupa. “At BetterLife Pharma, we are looking at psychedelic molecules, essentially second-generation psychedelics, which obviate the whole tripping out part.”

According to Kroupa, BetterLife Pharma is a pureplay biotech firm that “runs science experiments and validates that a molecule works. There aren’t any clinics or end-users within this particular model.”

Clinical Trials and RWE

The panel featured Matthew W. Johnson, Professor of Psychiatry and Behavioural Sciences at John Hopkins’s Center for Psychedelic and Consciousness Research, Malcolm Barratt-Johnson, CMO of Albert Labs, and Andrew Pendrill, CEO at Delica, and was moderated by Henri Sant-Cassia, Co-Founding Partner at The Conscious Fund. The discussion highlighted the traditional pathway for clinical trials, timeframes, and cost.

“We need these regulatory bodies to vet these medications as well as all other medications for safety and efficacy, and so we need to move through the registration trials,” said Johnson. “Deep appreciation for the FDA, the EMA, and equivalent bodies, and what they do and the necessities of clinical trials.”

However, Johnson also stressed that “it does seem frustrating and horrific that people with a disorder like cancer can’t be treated more immediately given what we know at this stage  of the science.”

“I think we’re in a very difficult position globally with psychedelics and all other medicines. We’ve reached a point now where science is advancing so quickly that we can’t treat all the patients with the medicines we have available to us. There’s only a limited number of patients, within reason with which you can treat as any limited amount of money. We’re very lucky because at this point in time, we’ve got so much science available to us, and it is getting too expensive. We have to find other ways of treating patients. We have to find other ways of doing research. If we don’t, we’re going to lose out enormously,” said Barratt-Johnson.

NanoPsy

NanoPsy is a biotech company that uses nanotechnology for theranostic applications to improve psychedelic drug efficacy. The panel featured Bojan Krasic, Director at NanoPsy, and Max Arella, Scientific advisor for R&D.

NanoPsy is developing nano balls, “a magnetic vectorized nanocapsule for penetration in brain cells and switchable on-demand drug release.”

“Nano balls are covered with a small particle of iron and can be applied to magnetic fields and localized directly at a certain place of the brain. It has been shown that this technology works for six other products, many of them concerning cancer treatment. We know that this technology is safe and effective, focusing on a certain specific part of the brain,” said Arella.

According to Arelle, this technology can accelerate any application of psychedelic drugs by using smaller amounts administered directly in the brain.

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The conversation featured Ronan Levy, Executive Chairman of Field Trip Health, Kathryn Tucker, Special Counsel at Emerge Law Group, Dustin Robinson, Founder at Mr. Psychedelic Law,  and was moderated by Richard Skaife, Co-Founding Partner at The Conscious Fund. Panellists discussed advocacy groups, access to psychedelic therapies, and drug regulations.

“It doesn’t make sense that someone can choose to take a drug to kill themselves and not choose to take a drug that may help them opt to not kill themselves, or at a minimum, make the process of dying much more humane,” said Levy.

“The money will follow the science and if people take the time to look at the science and read the research, they will realize that there’s a lot of substance behind this. This is not like a bunch of hippies telling their story about how they had mind expansion. This is very educated doctors and scientists that are proving out through research and the FDA looking at it and designating some of these compounds as a breakthrough,” said Robinson.

“Until the law moves either through access or through an interesting and unusual avenue like the right to try, or the substance is rescheduled, there will be no legal access for therapeutic use,” said Tucker.

PharmAla Biotech

PharmAla Biotech is a Canadian biotechnology company focused on developing novel processes for manufacturing MDMA and other MDXX substances, researching novel formulation methods and delivery pathways. The panel featured Nicholas Kadysh, Founding CEO of PharmAla Biotech, and was moderated by Justin Ling, investigative journalist at VICE, Maclean’s, The Globe & Mail, and Foreign Policy.

“Both MDMA and psilocybin have been designated as breakthrough therapies by the FDA. I would say that on the pathway to becoming approved medicines for various treatments, they’re kind of at the same stage. Maybe psilocybin is a hair ahead, but not by much,” said Kadysh. “Part of the reason that we got into this business is psilocybin at the end of the day is relatively easy to obtain. They’re mushrooms. They grow relatively easily. You can extract psilocybin; you know that’s doable. MDMA is a synthetic drug, and so you need to manufacture it, you need to synthesize it in GMP conditions and it’s hard, not a lot of people are doing that. We saw for ourselves the ability to get there relatively quickly and fill that market need. There’s this question of safety, and I think we all agree that MDMA is quite a potent molecule, and you want to be careful with it, right? That’s where we put our energy, and that’s where we’ve gotten our IP is on the safety side.”

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