Psychedelic drug development company Cybin will be conducting 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 released a statement saying that they have obtained approval this week from the ethics board at the University of the West Indies Hospital in Jamaica.
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.)
At a certain dose, when Psilocybin binds to serotonin receptor 5-HT2A in the brain, it 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.
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. 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 use of Psychedelics as a form of therapy is slowly being recognised. 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 announced it’s 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.
Aside from psilocybin, the company is also 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.