Perched atop the floor-to-ceiling metal racks at AJNA Biosciences in Littleton are rows of sealed plastic bags filled with grain and clusters of fruiting mushrooms. These specimens of psilocybe cubensis—better known as magic mushrooms—are part of AJNA’s drug development program aimed at creating the first federally approved botanical antidepressant.
“I believe that psilocybin can help millions and millions and millions, much larger than the 2% of the population that are willing to try it right now,” said Joel Stanley, AJNA CEO and co-founder of famed CBD producer Charlotte’s Web. “That will be revolutionary for our species.”
Psilocybin, the psychoactive compound found in mushrooms in the psilocybe genus, has long been used medicinally by a range of indigenous groups to treat anxiety, rheumatism and “spiritual illnesses.” Its use is protected under the Nagoya Protocol, a 2014 agreement to the U.N. Convention on Biological Diversity which addresses indigenous stewardship over genetic resources.
More recent research by Western scientists has found that psilocybin has the potential to treat depression and anxiety, ailments that AJNA reps were quick to point out had not seen a “new discovery” since the advent of SSRIs nearly 60 years ago. After receiving a research and development license from the Drug Enforcement Agency to legally grow psilocybin starting in 2022, AJNA has been in the process of developing a novel antidepressant that would allow patients to effectively microdose on psilocybin several times a week instead of taking conventional medication.
Obtaining FDA approval, Stanley said, is paramount to expanding accessibility.
“Only a small percentage of people are going to be brave enough to use it for their healing if it’s not FDA-approved,” he emphasized. “Western medicine wouldn’t accept it.”
Alex Albu, one of AJNA’s head mushroom cultivators, worked with medicinal and gourmet mushrooms for more than ten years. His first “true” experience with psychedelics was an ayahuasca ceremony in Peru.
“I mark my life in a before and after,” he reflected. “These medicines are so powerful and can be life-changing and paradigm-defying. I do think our world would be a lot better for it if more people had access to it.”
Regular microdosing must have a consistent dosage to be effective, something that “grey market” or homegrown psilocybin cannot guarantee.
According to Albu, “the stringent nature of having gone through everything to get to [FDA approval] ensures that the dosing will be very precise.”.
To complete the rigorous process of securing FDA botanical drug classification, AJNA must prove that the chemical makeup and dosage of each unit will be the same every time. That’s a tall order for an organic substance composed of naturally occurring compounds. AJNA Vice President Scott Hansen confirmed that standardization—uniformity—and characterization—testing to prove uniformity—are its two biggest hurdles.
“The mushrooms don’t develop 100 different compounds each time they grow, [but] they may have a slightly different mixture of compounds, depending on their life cycle, where they are in the harvest,” said Hansen. “Nature is variable on its own, but we’re trying to put some controls in place so that we can make it as reproducible as possible.”
Using liquid chromatography and other techniques, Hansen’s lab is in the process of parsing out each compound present in each mushroom. Albu’s team keeps the lab supplied with enough mushrooms to run their experiments. They are also responsible for standardizing the mushrooms’ growing conditions and genetic makeup, which Albu called “trying to marry nature, doing what it does, with this very precise pharmaceutical future FDA stuff.”
At the federal level, psilocybin is still listed as a Schedule 1 drug under the United Nations 1971 Convention on Psychotropic Substances. However, over the past several years, social acceptance has grown as studies have found the fungi could be used to treat a variety of ailments from alcoholism and addiction to PTSD.
Denver took a big step to grant more people access to psilocybin mushrooms when voters decriminalized them in 2019, with the rest of the state following suit in 2022. Since then, several other states and cities have taken the cue. While Albu is excited to see psychedelics become more accessible, he is wary of the American healthcare system.
“We should tread carefully and with intention,” he said. “It depends on [who] are the people who are already doing it, What would they want?”
Many psilocybin activists are also wary the continued embrace of psychedelics could harm Indigenous culture and tribes, especially if a marketable drug hits the shelves. In a nod to the Indigenous roots of knowledge around psilocybin, AJNA is participating in a reciprocity program with several First Nations tribes in the American Northwest. While AJNA declined to name the tribes involved, they are planning to work within the bounds of tribal and U.S. law to encourage the cultivation of gourmet, medicinal and eventually psychedelic mushrooms on tribal land.
AJNA plans to advance psilocybin to phase one of clinical trials in the second half of 2024 and enter phase two in the next several years. The company hopes to gain FDA approval and bring the drug to the American market by 2030.
Above all, Albu wants to keep the drug affordable, something echoed by Stanley. While AJNA is focused on drug development and Stanley said the company has limited control over insurance and commercialization, Albu has faith in the mushrooms themselves to keep prices down.
“It helps to shed so many of the nonsense things that we pursue,” he said. “It could mark a signpost in the history of mental healthcare if done right.”