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A Littleton company is developing a drug using psilocybin mushrooms that it hopes one day will be offered as a natural – and legal – alternative to traditional antidepressants.

AJNA BioSciences is a biotechnology firm that uses hemp and mushrooms to formulate new, botanic drugs for clinical trials. In 2022, it received a research and development license from the federal Drug Enforcement Administration to legally grow psychedelic mushrooms and began developing a microdose formulation.

The goal, said CEO Joel Stanley, is to create a standardized psilocybin product and dosage for U.S. Food and Drug Administration approval, so that one day doctors can recommend it to their patients to treat conditions like depression.

Microdosing is a practice that involves taking small amounts of psilocybin — usually between .1 and .4 grams — regularly to enhance well-being. That dosage is meant to be “sub-psychedelic,” meaning it’s not strong enough to feel the effects or hallucinate in most cases.

The majority of data collected around microdosing is anecdotal or self-reported. Microdosers, some of whom use LSD instead of mushrooms, often say they see improvements in mood, focus and creativity, among other benefits. But clinical research into microdosing is limited and has yielded less promising results in its efficacy, with at least one researcher stating that anecdotal reports about its benefits “are almost certainly biased by the placebo effect.”

Stanley, however, is a believer having tried microdosing himself in the past.

“I have no question that it’s working for a lot of people … but no one knows what they’re taking and what their milligram dose of these different tryptamines is. The strains are going to vary in their supply,” Stanley said. “Without standardizing it and understanding dose we can’t find a truly repeatable outcome.”

This wouldn’t be the first time the FDA considered psilocybin as a medical treatment. In 2018, the agency designated a synthetic psilocybin formulation as a “breakthrough therapy” because of its potential to treat depression when paired with therapy. The move marked a milestone for advocates because the designation expedites the drug development and review process within the FDA.

While that is promising, David Kroll, professor of natural products pharmacology at the University of Colorado’s Anschutz Medical Campus, said AJNA will have additional hurdles to clear with the agency. For one, the FDA approves specific formulations, not the substance at large. The fact that AJNA is creating a botanic drug complicates matters further.

Psilocybin mushroom of AJNA BioSciencesxe2x80x99 cultivation facility in Littleton, Colorado on Wednesday, December 13, 2023. (Photo by Hyoung Chang/The Denver Post)
AJNA BioSciences’ microdosing formulation is extracted from a single strain of psilocybe cubensis mushroom. It’s considered “full spectrum” because it includes psilocybin and other naturally occurring compounds called tryptamines. (Photo by Hyoung Chang/The Denver Post)

“The modern drug regulation system was not created to deal with plant-derived medicines. It just wasn’t. It’s all been patchwork,” Kroll said.

He points to a drug called Sativex, which is derived from cannabis and approved for prescription use to treat multiple sclerosis symptoms like muscle spasms and stiffness in more than two dozen countries. The United States is not one of them.

Still, Kroll is somewhat optimistic about AJNA’s prospects for FDA approval.

“I think it is possible, yes,” he said.

Psilocybin’s status as a Schedule I substance should not impact the company’s path toward FDA approval, Kroll added. In fact, if the drug were approved by the FDA, it would prompt a rescheduling review by the DEA since Schedule I substances are perceived to have “no currently accepted medical use” and a high potential for abuse.

That may soon be the case with MDMA, which is also listed as Schedule I. In December, the Multidisciplinary Association for Psychedelic Studies (MAPS) submitted a new drug application for the substance, commonly known as ecstasy, after completing Phase 3 clinical trials using it to treat post-traumatic stress disorder.

“If all goes well, it’s possible that FDA approval for the prescription use of MDMA-assisted therapy for PTSD could take place around August 2024, with DEA rescheduling legally required to take place within 90 days after FDA approval,” the organization’s founder Rick Doblin said in an announcement.

AJNA BioSciencesxe2x80x99 8 inch thick safe for the psilocybin mushroom at the cultivation facility in Littleton, Colorado on Wednesday, December 13, 2023. (Photo by Hyoung Chang/The Denver Post)
AJNA BioSciences grows mushrooms under a research and development license issued by the Drug Enforcement Administration. (Photo by Hyoung Chang/The Denver Post)

Background in botanic drug development

Stanley feels equipped to navigate the process given his background in the botanic drug space. In 2011, he and his six brothers founded Charlotte’s Web, a company that specializes in hemp extraction and manufacturing products using cannabidiol (CBD). Last year, it was named the official CBD partner of Major League Baseball because of its rigorous product standards.

Long before that, however, Charlotte’s Web helped broaden public knowledge about the potential medicinal uses for cannabis. The company is named after a young girl, Charlotte Figi, who suffered from frequent and severe seizures because of Dravet syndrome, a rare and potentially life-threatening genetic disease that causes unrelenting epilepsy in children and adults.

When she was 5 years old, her family gave her CBD and Charlotte’s condition improved overnight. The seizures dropped from thousands a month to just a few.

CEO Joel Stanley of AJNA BioSciences poses for a portrait at the psilocybin mushroom cultivation facility in Littleton, Colorado on Wednesday, December 13, 2023. (Photo by Hyoung Chang/The Denver Post)
CEO Joel Stanley of AJNA BioSciences at the psilocybin mushroom cultivation facility and lab in Littleton. (Photo by Hyoung Chang/The Denver Post)

The Stanley brothers had provided Figi with CBD extracted from a strain of cannabis that was high in CBD and low in tetrahydrocannabinol (THC), the psychoactive compound that produces a high. (The 2014 Farm Bill defined strains of cannabis with less than 0.3% THC as hemp; the 2018 Farm Bill legalized cultivation of it nationwide.)

CBD, then a relatively unknown cannabinoid, became a household name in 2013 after CNN featured Figi’s story, inspiring droves of parents to seek it out to help their ailing children.

Joel Stanley is no longer involved with Charlotte’s Web, but that experience inspired him to push the boundaries of innovation in plant-derived medicine. (Charlotte Figi died in April 2020 after contracting what her family suspects was COVID-19.)

“Back in 2012, when I met Charlotte, and the next few years my eyes — I think the world’s eyes — were opened to the first time that a standardized botanical extract, albeit from hemp, was surpassing the efficacy of multiple FDA-approved drug for multiple indications, seizure disorders being one of them,” Stanley said.

By taking AJNA’s psilocybin medication through clinical trials, Stanley aims to avoid the pitfalls of the CBD explosion, which enabled an influx of bad actors to enter the market, he said.

“There are thousands and thousands of people that think they’ve tried CBD and it failed them, when there are thousands and thousands of people that were actually buying a product that didn’t have CBD in it,” Stanley explained. “What it taught me is, one, botanics can be a powerful medicine. And, two, watching the rise and fall of the industry, so to speak, that some botanics deserve to go through the level of scientific rigor (and) standardization that pharmaceuticals do.”

AJNA’s microdosing formulation is an extraction from a single strain of psilocybe cubensis mushrooms, the most well-known psychedelic variety. The drug is considered “full spectrum” because it does not isolate the psilocybin and instead includes other compounds known as tryptamines, which occur naturally in the mushrooms.

AJNA is in the final stages of its drug formulation process and expects to enter pre-clinical trials using rodent models for toxicity research in early 2024 before starting human clinical trials later in the year, Stanley said.

The company is also currently conducting Phase 1 trials in Australia for a hemp-based cannabinoid product intended to treat symptoms of autism spectrum disorder. It’s collaborating with Charlotte’s Web on that initiative.

If AJNA succeeds, having a federally approved psilocybin drug could solve one of the trickiest pieces of the legal landscape: accessibility. Since Denver decriminalized psilocybin in 2019, it has remained illegal to sell the substance. Prop 122, the voter-approved measure legalizing psilocybin therapy, also prohibits the sale of “magic mushrooms” and does not permit the establishment of retail stores like dispensaries.

“The greatest good we can do for products like this… is create a reliable source with as much data behind it as possible so if it’s going to work for someone it’s the same thing over and over again,” Stanley said. “That’s what’s lacking in the black market and supplement markets.”

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