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Mugglehead Magazine
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Cybin receives FDA approval for new in-human clinical trial

Patient enlistment for new study to treat Major Depressive Disorder set to begin promptly

Cybin receives FDA approval for new in-human clinical trial
Photo via Cybin

A renowned biopharmaceutical company has received a “may proceed” letter for its new clinical trial examining the effects of an altered psilocybin compound on mental health.

On Monday, Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) announced that it had been granted Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for a new in-human study assessing CYB003, a modified psilocybin molecule.

The objective of this new research is to investigate the potential of CYB003 for treating Major Depressive Disorder (MDD) in volunteers. Cybin claims that this will be the first time a novel psilocybin analog has begun clinical advancement and that the company anticipates providing an interim pharmacokinetic and safety data report in Q4 this year.

In simple terms, analog means altered molecular structure and pharmacokinetic denotes the examination of effects that a drug has on a living organism.

Read more: Entheon Biomedical hands off DMT clinical study to Cybin

Read more: Numinus to offer ketamine-assisted psychotherapy

Cybin is a prominent biopharmaceutical leader in the psychedelic industry with a keen focus on mental well-being. Founded in 2019 and based in Canada, the company focuses on developing psychedelics into therapeutics and also has operational infrastructure across the United States, Ireland, the Netherlands and the United Kingdom.

CYB003 is a deuterated analog of psilocybin, meaning that the novel compound studied by the company has had hydrogen replaced by deuterium in order to alter the way it is metabolized in the human body.

CYB003 is designed to conceivably remedy the limitations and difficulties of orally administered psilocybin. Cybin’s preclinical data indicates that CYB003 demonstrated traits superior to regular or orthodox psilocybin, including a quicker onset of effects for a shorter duration and less discrepancy between plasma levels.

Cybin believes that its novel psilocybin analog could potentially lessen time and resource burdens on patients. The company also feels that CYB003 could theoretically enhance the adjustability and accessibility for this category of psychedelic therapy.

“Multiple academic studies have shown that psychedelic-based treatments, like psilocybin, may have the potential to revolutionize mental healthcare, but few companies have addressed the well-known limitations and side effects of oral psilocybin. We believe CYB003 has the potential to offer people in need with a more tolerable and potentially more effective treatment option. We look forward to advancing this important compound through clinical development,” Said Doug Drysdale, Cybin CEO.

One noteworthy finding discovered in preclinical trials conducted on multiple species with CYB003 was a 50 per cent drop in the variability of effects, suggesting that doses of the novel analog could be administered more accurately than classic psilocybin.

Additional findings included a 50 per cent reduction in required dosage, a 50 per cent shorter onset time and a nearly 100 per cent increase in brain penetration for the analog. These discoveries showed that there was a potential to maintain adequate efficacy while limiting side effects, a conceivable probability that a shorter treatment duration would be required with enhanced therapeutic composure and a significantly less variable treatment response for CYB003 in comparison to conventional psilocybin.

The newly approved Phase 1/2a trial will be a structured controlled analysis designed to assess subjects suffering from mild to extreme MDD. The six-week study will evaluate response and remission in patients twice, and will notably not require participants to discontinue taking anti-depressants.

Utilizing the Montgomery-Asburg Depression Rating Scale, the experiment will evaluate the quick onset of anti-depressant effects from the analog compound on the day doses were administered. Additionally, the study will determine the efficacy of CYB003 when given at up to two doses of 12 milligrams and will render crucial PK and safety data relevant to clinical proceedings moving forward.

“This Phase 1/2a trial represents the first time that a psilocybin analog will be evaluated for the treatment of MDD and is the key next step forward with our ultimate goal of providing a new and effective treatment for people suffering with mental health conditions,” added Drysdale.

Cybin stock dropped by 6.02 per cent today and is currently sitting at US$0.58 on the New York Ventures Exchange.

Cybin receives FDA approval for new in-human clinical trial

Photo via Cybin


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