Psilocybin microdosing drug is being developed in Littleton
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.
“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.