- Oregon is first state to permit supervised use of psilocybin, signaling shift in stigma
- CYBN entering phase 2 of clinical study of sublingual psilocybin for the potential treatment of MDD
- Newly discoverable data from psychedelic studies may potentially create entirely new marketplace of safe and effective drugs
Cybin (NEO: CYBN), a mushroom life sciences company, is working to become the first to bring a psilocybin drug to market targeting major depressive disorder (“MDD”). According to the National Institute of Mental Health, more than 18 million people in the United States — and 300 million people worldwide — experience major depression. Psilocybin has become a focus for academic institutions and companies whose clinical studies have been showing the effectiveness of psychedelics in mental health treatment. The stigmas around mushrooms are beginning to fade.
Most cities have decriminalized psilocybin, but Oregon is the first to permit supervised use statewide (https://ibn.fm/e3Spg). The passing of Measure 109 does not legalize the everyday use of psychedelic mushrooms but instead enables the regulated use of the shrooms in a therapeutic setting. Over the next two years, regulatory details will be worked out, including the qualifications required for therapists to use the mushrooms. The Oregon Health Authority will provide oversight for the program, and therapy recipients will undergo pre-screening, a supervised therapy session and post-use evaluation. Psilocybin is still considered a Schedule 1 drug.
Since 2018, the FDA has labeled psychedelic psilocybin a “breakthrough therapy” to treat MDD (https://ibn.fm/QCoge). This designation fast tracks the substance for clinical studies and for promising therapies that treat serious or life-threatening conditions and provide therapeutic benefits over available treatments (https://ibn.fm/REbvg).
On Nov. 4, 2020, John Hopkins Medicine researchers published their latest psilocybin study in “JAMA Psychiatry.” According to Alan Davis, PhD and adjunct assistant professor of psychiatry and behavioral sciences at John Hopkins University School of Medicine, the results could be a game-changer (https://ibn.fm/EY74h).
“The magnitude of the effect we saw was about four times larger than what clinical trials have shown for traditional antidepressants on the market,” said Davis. “Because most other depression treatments take weeks or months to work and may have undesirable effects, this could be a game changer if these findings hold up in future ‘gold-standard’ placebo-controlled clinical trials.”
Cybind is at the forefront of companies conducting clinical trials and is entering phase 2 of its clinical study of sublingual psilocybin for the potential treatment of MDD at the beginning of 2021. The study’s objectives are to determine the appropriate dosing, evaluate clinical efficacy, and assess the safety and tolerability of psilocybin.
The company seeks to partner with esteemed individuals and institutions leading the way in the research and development of pharmaceutical uses of psilocybin. This desire led to a partnership with the Toronto Centre for Psychedelic Science (“TCPS”) where some of the first academic research on micro dosing was published (https://ibn.fm/PI0t1). Both Cybin and TCPS have high standards for scientific rigor and transparency. CYBN believes that newly discoverable data from psychedelic studies can potentially create an entirely new marketplace of safe and effective drugs.
For more information, visit the company’s website at www.Cybin.com.
NOTE TO INVESTORS: The latest news and updates relating to CYBN are available in the company’s newsroom at https://ibn.fm/CYBN
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