Psychedelic biopharmaceutical company Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) announced today the dosing of the first two patients in the company’s Phase 1/2a clinical trial evaluating the CYB003 deuterated psilocybin analog as a treatment option for major depressive disorder (MDD). The clinical milestone marks initiation of first ever novel psilocybin analog to enter clinical development.
Cybin is focused on progressing Psychedelics to Therapeutics™ and believes the commencement of the trial cites a major company milestone. CEO Doug Drysdale particularly noted how quickly the drug progressed from development to initial trial citing a rapid advancement of only 18 months time.
Mr. Drysdale also shared light in the latest release on the company’s goal to continue their focus on establishing the company as a leader the best psychedelic therapy space.
He cited that the company’s rigorous preclinical work and ongoing clinical development of CYB003 leads Cybin to be believe they have the potential to unlock the powerful benefits of psilocybin for the treatment of MDD without its well-known limitations.
Cybin’s CYB003 Psiloycybin Analog
CYB003 is a deuterated psilocybin analog designed to achieve less variability in plasma levels while delivering a faster onset of action and shorter duration of effect with potentially better tolerability compared to oral psilocybin all designed to provided a more positive overall outcome for patients.
Preclinical research has led Cybin to believe that CYB003 has the potential to effectively treat major depressive disorder (MDD) and alcohol use disorder (AUD).
CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Initial preclinical data demonstrated that CYB003 has the potential to reduce time and resource burden on patients, providers, and payers, and possibly improve scalability and accessibility of treatment.
Specifically, in multi-species preclinical studies comparing CYB003 with oral psilocybin, data demonstrated:
- a well-tolerated profile following several doses in multiple species that supports repeat dosing;
- a similar in vitro and in vivo pharmacology profile when compared to psilocin, the active naturally occurring psychedelic agent in psilocybin;
- a 50% reduction in variability;
- a 50% dose reduction;
- a 50% shorter time to onset; and,
- nearly double the brain penetration indicating the potential for a less variable treatment response.
About the CYB003 Phase 1/2a Trial
The Phase 1/2a trial is a study conducted with people who have moderate to severe MDD in order to assess the efficacy of an active treatment administered twice.
This trial is double-blind and placebo-controlled, meaning that neither the participants nor the staff will be aware of whether any given person is receiving active doses or not. Response rates will be assessed after Week 3 (after first dose) and at Week 6 (after second dose).
Importantly, participants in the study who are currently receiving antidepressants will be permitted to keep taking them. The trial will assess the speed with which an antidepressant’s effect on the day of dose takes place using the Montgomery-Asberg Depression Rating Scale.
The study will also compare the benefits of a second dose of CYB003 administered at Week 3. In addition, the study will provide important data regarding safety and tolerability to help determine a clinical path forward.
An additional period of observation may be required to determine the effectiveness of treatment out to 12 weeks.
The detailed Phase 1/2a study protocol is available at clinicaltrials.gov under the Identifier number: NCT05385783.
If you are aged 21-55 and have MDD, researchers would like to hear from you for this study. You must be taking an antidepressant that isn’t working well enough for you.
The study requires a total of 11 outpatient visits and two 2-day inpatient stays. Participants who are within a reasonable drive to the Clinilabs Eatontown, New Jersey clinical research unit may pre-screen for study entry at www.depressionpsychedelicstudy.com or by calling (212) 994-4567.
Cybin CEO Doug Drysdale shared further insight into the trial itself stating, “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.”
In regards to what the future holds, Drysdale expects the 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 Cybin can continue to progress the company’s mission to help revolutionize the treatment landscape for people suffering from depression.
About Cybin
Cybin is a leading ethical biopharmaceutical firm with a growing network of renowned scientists and partners working on a mission to develop safe and effective medicines for patients to treat a wide range of mental health issues.
Cybin, a Canadian firm based in Toronto and founded in 2019, is currently active across Canada, the United States, the United Kingdom, the Netherlands, and Ireland.
The company’s Psychedelics to Therapeutics™ business focuses on engineering proprietary drug discovery platforms, developing innovative new delivery systems for drugs, researching novel treatment regimens and progressions formulations approaches for mental health disorders.
