Based on a growing body of clinical research, psychedelic-assisted therapy promises huge potential for the future of mental health care. But one part of the equation often left unaddressed in safety and efficacy studies is the treatment’s cost.
While studies have shown that drugs like psilocybin and MDMA can help improve the lives of those suffering from mental health conditions including depression and PTSD, the treatments offered in the majority of these studies last several hours and require the oversight of at least two therapists. Considering the already-high cost of a single hour of therapy without the use of a psychedelic, one can imagine how quickly the cost of this kind of intervention would add up.
At private biotech company Beckley Psytech, CEO and co-founder Cosmo Feilding-Mellen and team are building upon the work of the non-profit Beckley Foundation, founded by his mother Amanda Feilding in 1998. Where the Beckley Foundation focuses on funding early-stage academic research, Feilding-Mellen says Beckley Psytech is about taking that research to the next level: drug development.
“That’s a very different proposition, because it requires many things, two of which are obvious: a lot of money, and an additional array of skills and experience,” says the CEO. “We’re a focused drug development company and we’re taking a few assets that we think are the most exciting through the drug development process.”
To start, Beckley Psytech will be exploring psychedelic compounds that could be used in one of two ways: either in a full-dose treatment administered within a therapeutic setting, or as a low-dose product to be used in outpatient treatment (that is, taken home and used like any other medication).
“The main compound that we’re developing is a drug called 5-MeO-DMT,” says Feilding-Mellen. “We think it’s an exciting potential compound because it’s very short-acting and very potent.”
The drug, believed to be several times stronger than the related compound N,N-Dimethyltryptamine, or DMT, occurs naturally in the venom of the Sonoran Desert toad and is also found in a number of plant species. A single inhalation of vaporized 5-MeO-DMT can lead to feelings of oceanic boundless, a correlatation of mystical experiences.
Users may describe feeling a sense of oneness with the universe, or what some refer to as “ego death,” when the boundaries between oneself and the rest of the world feel as if they have completely dissolved.
While scientific research on the compound is limited, a study published in Psychopharmacology in 2019 found that participants who took a single dose of 5-MeO-DMT reported improved life satisfaction and mindfulness, as well as lower levels of depression and anxiety. These effects persisted for four at least weeks after taking the drug.
The Challenge of Commercializing Psilocybin, MDMA
While early and increasingly late-stage clinical data have shown that treatment with certain psychedelics can lead to positive treatment outcomes for patients, Feilding-Mellen says there could be a challenge in commercializing compounds like psilocybin and MDMA because of the additional protocols required for their administration.
“Requiring one or two therapists to sit in a room with a single patient for the entire duration of an MDMA or psilocybin experience, which is essentially a whole working day, is probably going to be very resource-intensive and expensive,” says Feilding-Mellen. “There is already a global shortage of psychotherapists, and this poses a potential bottleneck to patient access in the future.”
According to the CEO, 5-MeO-DMT may provide a better option, in that it can provide “a very profound, subjective experience in a short space of time, over within one hour.”
Working with a synthetic version of the drug, Beckley Psytech is hoping to show through trials that 5-MeO-DMT could be as efficacious as psilocybin or MDMA in the treatment of mental health disorders.
“If we can do that, it would potentially have a huge patient access advantage. We could treat more patients, and the resource utilization and cost of treatment would be lower,” says Feilding-Mellen.
Phase One Study Underway
Currently, Beckley Psytech is in the midst of a clinical research program focused on 5-MeO-DMT using a proprietary intranasal formulation of the drug, in a Phase One, single ascending dose study in healthy volunteers.
“The first step is testing the pharmacology and various biomarkers in terms of the effects of the drug and what it induces,” says Feilding-Mellen. Once complete, Beckley Psytech intends to conduct a Phase Two study in patients with treatment-resistant depression.
Feilding-Mellen credits the company’s experienced drug development team along with the pioneering work of his co-founder and mother, who has helped author more than 50 peer-reviewed publications in the field of psychedelics, for the company’s strong sense of direction. While he says that the science is important, he also says Beckley’s history has proven that understanding the on-the-ground uses of psychedelics is critical, too.
“It’s not just about the scientific literature, it’s also about being plugged into what’s happening in the real world,” he says. “We’re committed to protecting the ethos that the Beckley Foundation has had from the beginning.”