TORONTO, November 18, 2024–(BUSINESS WIRE)–Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company“), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today announced unprecedented 12-month efficacy data from its Phase 2 study of CYB003, a proprietary deuterated psilocin program in development for the potential adjunctive treatment of major depressive disorder (“MDD“). As previously announced, CYB003 received Breakthrough Therapy Designation by the U.S Food and Drug Administration (the “FDA“) for this indication, which provides an expedited review pathway.
“We are highly encouraged that our approach to treating MDD patients with two 16 mg doses of CYB003, three weeks apart, has demonstrated consistent, robust and sustained treatment benefits through to the 12-month follow up. The trajectory of effect is truly remarkable. We previously reported response and remission rates of 75% at four months. By the 12-month mark, response rates improved to 100% while 71% of participants were still in remission. These findings validate our dosing regimen and confirm that CYB003’s effects are highly durable and offer sustained relief,” said Amir Inamdar, MBBS, DNB (Psych), FFPM, Chief Medical Officer of Cybin. “At 12 months, the mean change from baseline in MADRS total score was nearly 23 points for patients who received two 16 mg doses. With such unprecedented response and remission rates and effects that are durable with two doses of CYB003, we have the potential to address a significant unmet need and deliver a truly transformative treatment for patients with MDD.”1
“Our Phase 2 study results are remarkable and validate both our intermittent dosing regimen, as well as CYB003’s potential to revolutionize the current standard of care in MDD,”1 said Doug Drysdale, Chief Executive Officer of Cybin. “We are quite possibly witnessing a watershed moment in mental health care treatment paradigms and practices.1 Up to two thirds of MDD patients do not achieve remission with first-line antidepressants, which have defined the current treatment standard. With CYB003, we have the opportunity to pivot away from the chronic, daily treatments that often only offer symptomatic relief, and move towards more patient-friendly infrequent, long-lasting therapeutics for MDD patients who do not achieve remission with existing treatments.1 Current intermittent treatments like esketamine, ECT and TMS require on average up to 36 outpatient visits per treatment cycle, burdening both patients and treatment centers. In comparison, CYB003’s two doses per treatment cycle have the potential to free up capacity for new patients and improve accessibility to treatment.1 We believe that these landmark results mark a profound and exciting shift as we move away from treating the symptoms of the disease to potentially changing the course of the disease.”1
Summary of 12-Month Efficacy Data for CYB003 16 mg
- Eight participants completed the 12-month follow-up of which seven received two doses (active-active) of 16 mg and one received a single dose of 16 mg (placebo – active).
- Mean change from baseline in MADRS was ~23 points after two doses of 16 mg (n=7).
- Mean baseline MADRS was 32 points across the 12 mg and 16 mg dosing arms.
- 100% of participants receiving two doses of 16 mg were responders.
- 71% of participants receiving two doses of 16 mg were in remission.
- The two participants in the 16 mg dosing arm that were responders (≥50% reduction in MADRS score) but not remitters had MADRS scores of 11; remission is defined as MADRS total score ≤10.
Summary of 12-Month Efficacy Data for CYB003 12 mg
- Thirteen participants completed the 12-month follow-up of which ten received two doses (active-active) of 12 mg and three received a single dose of 12 mg (placebo – active).
- Mean change from baseline in MADRS was ~18 points after two doses of 12 mg (n=10).
- 60% of participants receiving two doses of 12 mg were responders.
- 50% of participants receiving two doses of 12 mg were in remission.
- CYB003 has demonstrated an excellent safety profile. No new adverse events were reported in the 12-month follow up, including no reports of suicidality.
“As a late-stage neuropsychiatry company, we are nearing several key inflection points across our clinical pipeline. Having aligned on trial design with the FDA, we recently initiated our Phase 3 PARADIGMTM pivotal program which will evaluate CYB003’s efficacy and safety in a larger MDD population, and we expect to report Phase 2 topline results for CYB004, our proprietary deuterated dimethyltryptamine program for the treatment of generalized anxiety disorder, in the first quarter of 2025.1 We are committed to building on the positive clinical results to-date in both programs and to progressing CYB003 toward potential regulatory approval and commercialization,” concluded Drysdale.
Conference Call and Webcast Details:
| Date: | | Monday, November 18, 2024 |
| Time: | | 8:00 a.m. ET. |
| Dial-in: | | 800-579-2543 (U.S. Toll-Free) or 785-424-1789 (International) |
| Conference ID: | | CYBN1118 |
| Webcast: | | Register for the webcast here |
The archived webcast will also be available on the Company’s investor relations website on the Events & Presentations page.
Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.
With industry leading proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds.
Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.