Mushroom Medicine: Cybin hopes its sublingual form of synthetic psilocybin will one day be an FDA-approved medicine to treat major depression disorder.
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Psychedelic drug development company Cybin will launch a phase two clinical trial on its sublingual formulation of psilocybin, the psychedelic compound found in “magic mushrooms”, for patients with Major Depressive Disorder later this year.
The company announced that the ethics board at the University of the West Indies Hospital in Jamaica granted approval this week.
Doug Drysdale, the company’s CEO, says the approval to start a clinical trial is a big step.
“I really think we have the opportunity to revolutionize how you treat mental illness,” says Drysdale, who worked in the pharmaceutical industry for 30 years before joining Cybin. “There’s nothing else out there today that could enable you to remove a person’s depressive symptoms for potentially months at a time.”
The start of the trial is still subject to final confirmation by Jamaica’s Ministry of Health.
The psychedelic renaissance is well under way. Nasdaq-listed Compass Pathways, a U.K.-based company that has patented a polymorphic form of psilocybin, and nonprofit Usona both have received breakthrough therapy designation from the FDA for psilocybin therapies. The Multidisciplinary Association for Psychedelic Studies recently released data from its phase three clinical trial with MDMA-assisted therapy for post-traumatic stress disorder, showing that 67% of participants who received three treatments no longer qualified for a PTSD diagnosis and 88% experienced a clinically meaningful reduction in symptoms. Other companies like MindMed, which is studying LSD for anxiety and a modified version of ibogaine to treat opioid-use disorder, have also listed on Nasdaq.
Cybin, which went public on Toronto’s NEO Exchange through a reverse takeover of a mining company in 2019, plans to bring its dissolvable oral strip dosed with psilocybin to market to help treat major depressive disorder when coupled with therapy. The company still has an uphill battle to gain approval by the U.S. FDA.
Cybin’s phase two study will be conducted in two parts at Jamaica’s University of West Indies Hospital. The first part of the clinical trial will consist of a Phase IIa study of 40 patients to identify the equivalent dose of Cybin’s sublingual psilocybin formulation compared with a 25 mg pill of psilocybin. Cybin’s sublingual film is designed for rapid absorption, a faster onset, and a shorter duration. The second phase will be a randomized, placebo-controlled Phase IIb study, in 120 patients with major depressive disorder. (Eighty patients will be in the active arm, while 40 patients will be in the placebo arm.)
Psilocybin is a tryptamine that binds to serotonin receptor 5-HT2A in the brain. At certain doses, the psilocybin elicits profound changes in consciousness. Studies in academic institutions including Johns Hopkins and Imperial College London have found that psychedelic drugs have significant potential in treating mental health disorders, including certain types of depression.
Cybin is starting with psilocybin, but the company is developing novel molecules based on other psychedelic compounds. The company has filed 12 provisional patent applications for novel psychedelic compounds.
The new molecules are based on classic psychedelic substances like psilocybin and DMT but are expected to have “optimized,” as Drysdale says, pharmacokinetics like shorter duration and reduced psychedelic side effects. Drysdale says Cybin plans to start human trials on three to four novel compounds later this year.
One of its new compounds, which the company refers to as 003, will target alcoholism. The compound is a modified version of a short-acting tryptamine. Cybin wants to reduce the time a patient needs to spend on a psychedelic experience. “We want to shorten the overall duration of these treatments,” says Drysdale. “We have quite a lot of control over it.”