- First dose is administered as first-ever novel psilocybin analog enters clinical development
- Cybin believes CYB003 has potential to successfully address the challenges and limitations of oral psilocybin
- The high level of participant interest in the study indicates a significant unmet need for alternative treatment options for major depressive disorder (“MDD”)
Cybin (NEO: CYBN) (NYSE American: CYBN) has reached a milestone in its mission to create safe and effective therapeutics. The company is conducting a phase 1/2a trial evaluating CYB003, its lead investigational molecule and the first-ever novel psilocybin analog to enter clinical development. Late last month, the first two trial participants were dosed (https://ibn.fm/JXADp).
“To commence dosing in our first-in-human phase 1/2a trial is a tremendous milestone for Cybin, especially having reached the clinic within just 18 months,” said Cybin CEO Doug Drysdale. “Our goal continues to focus on becoming a leader in creating the best psychedelic therapies for patients, and today we have moved one step closer. Through our rigorous preclinical work and ongoing clinical development of CYB003, we believe we have the potential to unlock the powerful benefits of psilocybin for the treatment of major depressive disorder (‘MDD’) without its well-known limitations.”
The in-human trial is critical to the company’s continued development of CYB003, a deuterated psilocybin analog that Cybin believes has potential to successfully address the challenges and limitations of oral psilocybin. According to the company’s preclinical research, CYB003 achieved less variability in plasma levels, along with faster onset of action, improved brain penetration, and shorter duration of effect, compared to oral psilocybin. CYB003 has the potential to reduce time in the clinic, which could allow more scalability and access for this treatment.
As a randomized, double-blind, placebo-controlled study, the current phase 1/2a trial will evaluate individuals with moderate to severe MDD. Those who qualify for the study are between the ages of 21 and 55, have a verified diagnosis of MDD and are unsatisfied with their current prescribed medication and treatment. Participants will be allowed to remain on their current medication throughout the trial.
“The high level of participant interest in our study serves to validate the significant unmet need for alternative and better treatment options to improve mental health conditions,” said Drysdale. “We expect that this phase 1/2a trial will provide valuable insights and data. These findings will be critical in establishing a safe and efficacious treatment profile for CYB003 so we can continue to progress our mission to help revolutionize the treatment landscape for people suffering from depression.”
Cybin is a leading ethical biopharmaceutical company working with a network of world-class partners and internationally recognized scientists on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The company is focused on progressing psychedelics to therapeutics by engineering proprietary drug-discovery platforms, innovative drug-delivery systems, and novel formulation approaches and treatment regimens for mental health disorders.
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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