Cybin has begun dosing the first patients in its Phase 1/2a trial for Major Depressive Disorder. For investors and industry analysts, Cybin has long been one of the more promising firms in the space, with an experienced team, a promising pipeline, and cash in the bank. They were, however, behind other big players in terms of clinical trial progress.
So today’s announcement marks a major step forward, officially dosing patients in the clinic with their lead compound CYB-003 (a psilocybin analog).
See below for the full press release and for more information check out Cybin Announces Financial Results and $35M Equity Program and Cybin Acquires DMT Clinical Study from Entheon Biomedical.
Cybin Inc. Announces First Participants Dosed in its Phase 1/2a Trial of CYB003 for the Treatment of Major Depressive Disorder
Clinical milestone marks initiation of first ever novel psilocybin analog to enter clinical development
TORONTO–(BUSINESS WIRE)–Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, is pleased to announce that the first two participants have been dosed in its Phase 1/2a trial evaluating CYB003 for the treatment of major depressive disorder (“MDD”).
“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. 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,” said Doug Drysdale, Chief Executive Officer of Cybin. “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 MDD without its well-known limitations.”
“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. 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,” continued Drysdale.
CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect. These 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 randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD. Participants will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after first dose) and at Week 6 (after second dose). Importantly, participants in the trial that are currently being treated with antidepressants will be allowed to remain on their antidepressant medication.
Using the Montgomery-Asberg Depression Rating Scale, the trial will assess rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the incremental benefit of a second dose of CYB003 when administered at Week 3 and will provide important PK and safety data to determine a clinical path forward. An optional period of assessment will help determine the durability of treatment effect out to 12 weeks. The detailed Phase 1/2a study protocol is available at clinicaltrials.gov under the Identifier number: NCT05385783.
This research study is recruiting individuals between the ages of 21 and 55 who have been diagnosed with MDD and who are currently taking an antidepressant medication that is not working to their satisfaction. Participation includes 11 outpatient visits and two 2-day inpatient stays. Participants who are located within reasonable travel distance to the Clinilabs Eatontown, New Jersey clinical research unit, may pre-screen for study entry at www.depressionpsychedelicstudy.com or by telephone at (212) 994-4567.
About Cybin
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, novel formulation approaches and treatment regimens for mental health disorders.
Contacts
Investor & Media Contact:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.com
Gabriel Fahel
Chief Legal Officer
Cybin Inc.
1-866-292-4601
