- A new study shows promise in treating alcohol addiction with psychedelic mushroom compound, psilocybin
- These results align with efforts and expectations of Cybin, a leading ethical biopharmaceutical company championing psilocybin
- After receiving FDA approval, the company is moving forward with a first-in-human clinical trial evaluating CYB003
A new study published in JAMA Psychiatry offers hope for those struggling with alcoholism (https://ibn.fm/jV5o9), showing promise in treating alcohol addiction with the psychedelic compound psilocybin. This news aligns with initiatives of Cybin (NEO: CYBN) (NYSE American: CYBN), a leading ethical biopharmaceutical company, which has a drug in development, CYB003, for the treatment of alcohol use disorder (“AUD”) and major depressive disorder (“MDD”) (https://ibn.fm/5IPD1).
In addition to reporting three million deaths annually attributed to alcohol use (5.3% of all deaths), the World Health Organization (“WHO”) states that the harmful use of alcohol is a causal factor in more than 200 diseases and injury conditions and that, overall, 5.1% of the global burden of disease and injury is attributable to alcohol (https://ibn.fm/ytu6c). These statistics make the JAMA-published study even more significant.
The study, conducted by the Department of Psychiatry at New York University’s (“NYU”) Langone Center for Psychedelic Medicine, discovered that providing two doses of psilocybin and psychotherapy reduced heavy drinking by 83% within eight months.
“In this double-blind, randomized clinical trial with 93 participants, the percentage of heavy drinking days during 32 weeks of follow-up was significantly lower in the psilocybin group than in the placebo group, containing the antihistamine diphenhydramine,” the article stated.
By contrast, those who received the antihistamine placebo only reduced their drinking by 51%. All participants received up to 12 psychotherapy sessions before and after the psilocybin treatments.
The study concluded that administering psilocybin in combination with psychotherapy “produced robust decreases in the percentage of heavy drinking days over and above those produced by active placebo and psychotherapy. These results provide support for further study of psilocybin-assisted treatment for Alcohol Use Disorder (‘AUD’).”
These results align with the efforts and expectations of Cybin, which is creating Psychedelics to Therapeutics(TM). The company is making significant headway with its flagship deuterated psilocybin analog, CYB003. CYB003 has the potential to effectively treat AUD and MDD. The substance is designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect, and potentially better tolerability than oral psilocybin for a better patient outcome overall.
Earlier this summer, Cybin received a “may proceed” letter and Investigational New Drug Application (“IND”) clearance from the U.S. Food and Drug Administration (“FDA”) for its Phase 1/2a first-in-human clinical trial evaluating CYB003 (https://ibn.fm/OQsmP). This milestone achievement marks the industry’s first-ever novel psilocybin analog to enter clinical development; the company has started recruiting patients and expects to provide an interim pharmacokinetic and safety readout later this year.
“We are extremely pleased to advance CYB003 into clinical development so quickly,” said Cybin CEO Doug Drysdale. “Our team has worked diligently to achieve this major regulatory milestone, and we look forward to collaborating with Clinilabs, our drug development partner, to accelerate this program. This Phase 1/2a trial represents the first time that a psilocybin analog will be evaluated in humans for the treatment of MDD and is the key next step toward our ultimate goal of providing a new and effective treatment for people suffering from mental health conditions.”
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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