There’s a toad problem in the psychedelics industry, Sonoran toads specifically.
These large, underground-dwelling toads have N, N-Dimethyltryptamine (DMT) as a venom on their skin that the toad uses as a defense against predators. DMT is a type of natural psychedelic that has been gaining popularity among both researchers and random psychedelic experience seekers.
The Sonoran toad venom is in such high demand that they are being harassed and abused by people who want to experience the intense psychedelic experience that DMT gives anyone who ingests it. People are seeking out and finding these toads in central Arizona and southwestern New Mexico, which has forced the National Park Service to warn visitors not to lick the frogs and otherwise disturb their natural habitat for fear of a causing a catastrophic demise of the toad.
But science has come to the rescue of the toad.
Chemical synthesis of DMT was first explored as an option for DMT in clinical use in 2020.
Now, PsyBio Therapeutics Corp. (TSX-V: PSYB) (OTCQB: PSYB) is working to provide a biosynthetic version of the toad venom that can be used safely in research and ends the issue with procuring DMT from toads.
“Biosynthesis is a more environmentally sound, faster, and cost-effective way to manufacture these types of molecules than chemical synthesis, without endangering any species of toad or other natural creature,” said Dr. Michael Spigarelli, PsyBio’s chief medical and chief scientific officer, in a press release.
PsyBio has ongoing research and development for other naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, as well as other tryptamines and phenethylamines.
While PsyBio takes the approach of creating a biosynthetic psychedelic that is safe for the environment and offers protection to a certain specifies of toad, there are other companies looking to make a biosynthetic version of psilocybin as a simpler and cheaper option for clinical trial research and, eventually, development into a pharmaceutical.
There are a number of companies already creating a chemically synthetic psilocybin. Compass Pathways, Usona Institute, ATAI Life sciences, and Psygen Labs are considered to be among the leaders in the production of synthetic psilocybin.
According to a study, Compass Pathways developed and patented a new method for the chemical synthesis of psilocybin that improves on previous methods with an overall yield of 75%. But there’s a drawback: It uses an expensive chemical as a starting substrate resulting in high production costs that could limit its application as companies scale up production.
Core One Labs (CSE: COOL) (OTCQB: CLABF) has a different approach to making psilocybin for use in clinical trials that they claim is faster and much cheaper than other processes.
Scientists there found a way to optimize DNA sequences that can produce enzymes replicating the biosynthetic pathway used by psilocybe mushrooms, which allows bacteria to become factories for psilocybin production. The company expects to begin production of psilocybin with this process early this year. A price per gram has not been announced.
Finding which bacteria is best to use for generating psilocybin has become a new trend, with researchers in another study discussing growing psilocybin in metabolically engineered baker’s yeast, which is seen as more cost efficient.
“Our interest is not only to make kilogram-scale production of psilocybin, but to use the biological machinery to make new derivatives that aren’t available today,” said Nick Milne, one of the researchers of the study explaining the baker’s yeast process. “Thus, it is very useful that we could not only demonstrate the production of psilocybin, but also find many derivatives that could turn out to have important therapeutic relevance.”
Matthew Johnson, a psychiatry and behavioral sciences professor at John Hopkins University who has conducted extensive research on psilocybin, said in an article for the Center for Ethnobotanical Services that he and his colleagues pay between $7,000 and $10,000 per gram for synthesized psilocybin used in research.
That high cost is due in part to the processes involved in the synthesis of a form of psilocybin that meets standards set by the U.S. Food and Drug Administration’s Good Manufacturing Practice (GMP) regulations.
The cost of the substance being used in a clinical trial is one thing; the cost of the entire trial is another. For example, a recently published study about MDMA-assisted therapy for PTSD found that, once it is available for patients to use, perhaps by 2024, treatment would cost $11,537 per patient. That price includes the clinician’s fee, 3-4 sessions, and lab and pharmaceutical costs.
It’s becoming clear that more cost-effective measures for creating psilocybin and other naturally occurring psychedelics are needed, as more clinical trials with larger groups of participants loom on the horizon.
“Trials should involve larger numbers of patients who are representative of those clinical disorders for which these drugs may be used, and should include longer‐term follow‐up evaluations of safety and sustainability of favorable outcomes,” an article in World Psychiatry concluded.