Health Canada has allowed a phase 2 clinical trial of psilocybin in patients currently undergoing treatment with traditional antidepressants.
What Happened: A phase 2 trial on psilocybin, the active compound in “magic mushrooms,” will be led by Cybin Therapeutics, a privately-held psychedelics company (not to be confused with publicly-listed Cybin Inc. CYBN.
Cybin Therapeutics has licensed PEX010, a botanical psilocybin drug candidate, from drug developer Filament Health Corp. FLHLF.
The trial, expected to begin in the third quarter of 2022, will include patients with major depressive disorder who are undergoing selective serotonin reuptake inhibitor (SSRI) therapy, commonly used to treat depression, as well as other volunteers not using SSRIs.
Why It’s Important: Psilocybin and other psychedelics like LSD and DMT, work by interacting with serotonin receptors in the body. SSRI antidepressants like Fluoxetine (known by its brand name Prozac) work by blocking the reabsorption of naturally-produced serotonin in the nervous system.
As both types of compounds interact with serotonin receptors, most clinical research into psychedelics has so far asked patients taking SSRIs to stop their treatments before entering a psychedelics study. As such, interaction between psychedelics and SSRIs has become understudied.
"The effect of psilocybin therapy in patients taking traditional SSRI antidepressant medication is an extremely important investigation and we are thrilled to participate in this important research," said Filament CEO, Benjamin Lightburn.
"Many Canadians who battle depression undergo SSRI therapy, and until now, this has generally meant exclusion from psychedelic-assisted psychotherapy clinical trials," said Josh Taylor, founder of Cybin Therapeutics.
"If it can be demonstrated that PAP can be safely and effectively given to patients on SSRIs, many will stand to benefit. We feel this is an outstanding opportunity to show Health Canada that Cybin Therapeutics can improve patient outcomes with our team and developed protocols," Taylor concluded.
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