TORONTO–(BUSINESS WIRE)– Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced positive Phase 2 topline safety and efficacy data for CYB003, its proprietary deuterated psilocybin analog, being developed for the treatment of major depressive disorder (“MDD”).

Sustained and Incremental Response and Remission Rates with a Second Dose​ of CYB003 (Photo: Business Wire)

“We are delighted to share that CYB003 achieved the primary efficacy endpoint in this study and showed rapid and statistically significant improvements in depression symptoms after a single dose, with a clear incremental benefit of a second dose, resulting in 4 out of 5 patients in remission from their depression at 6 weeks,” said Doug Drysdale, Chief Executive Officer of Cybin. “This is an impressive finding and follows on from the unprecedented interim results we announced earlier this month. Importantly, the strength of the data supports progression to a Phase 3 study of CYB003 for the treatment of MDD.”

“The significant reduction in depression symptoms observed in our Phase 2 study is highly gratifying,” said Amir Inamdar, MBBS, DNB (Psych), MFPM, Chief Medical Officer of Cybin. “At the 3-week primary efficacy endpoint, a single 12mg dose of CYB003 showed a rapid, robust, and highly statistically significant improvement in depression symptoms compared to placebo, with a -14.08 point difference in change from baseline in MADRS (p=0.0005, Cohen’s d=2.15¹). This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16mg dose, which resulted in an improvement in symptoms of depression as measured using the MADRS total score by about 13 points versus placebo. These effects were evident on day one with the 16mg dose and were also highly statistically significant. When data from 12mg and 16mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75% were observed with CYB003 (12mg). With these findings in hand, we are encouraged by the potential of CYB003 to help those with MDD and look forward to progressing to a multinational, multisite Phase 3 study early next year.”

Summary of CYB003 Phase 2 topline efficacy data²:

• Rapid and large improvements in symptoms of depression observed after single doses of CYB003​:
  • An average of 13.75 points on MADRS (12mg and 16mg cohorts pooled) which is statistically significant from placebo at 3 weeks (p<0.0001) (n=34 total: n=24 on CYB003; n=10 on placebo)

• Clear incremental benefit of a second dose​:
  • Incremental and sustained benefit seen as a further 5.8 point improvement on the MADRS total score with a ​second dose of CYB003 (12mg) at 6 weeks​
  • 79% of patients were responsive to treatment and 79% of patients were in remission from their depression at 6 weeks after receiving two doses of CYB003 (12mg) (n=32 total: n=22 on CYB003; n=10 on placebo)

• Magnitude of improvement far superior compared to approved antidepressants and recently reported data with​ other psychedelics​:
  • Effects translate into unprecedented effect size (Cohen’s d > 2) (SSRIs = 0.24³)
  • These results compare favorably to pooled data from 232 industry studies of current standard of care antidepressants, selective serotonin reuptake inhibitors (“SSRIs”), submitted to U.S. Food and Drug Administration (“FDA”) which show an average improvement of 1.82 points on the MADRS total score vs. placebo.³

• Data support progression to a Phase 3 study

Safety and tolerability:

• CYB003 has demonstrated an excellent safety profile in doses tested, with all reported adverse events mild to​ moderate and self–limiting.

“Completing our Phase 2 study and presenting this extraordinary topline safety and efficacy data represents a much-anticipated milestone for us – a goal that we have all been tirelessly working toward. Our objective remains to design and deliver improved treatments for those suffering with mental health disorders, and we believe that we are one step closer to achieving that goal,” concluded Drysdale.

Upcoming Milestones for the CYB003 Program⁴

Cybin plans to submit topline data to the U.S. Food and Drug Administration (“FDA”) and request an end of Phase 2 meeting to be held in Q1 2024. Additional 12-week durability data from the Phase 2 CYB003 study is anticipated in Q1 2024. Recruiting for a CYB003 Phase 3 study is anticipated to begin by the end of Q1 2024.

Phase 2 Topline Study Review and R&D Briefing to be held today at 10:00 a.m. ET in New York City

Cybin’s leadership team is hosting a Phase 2 Topline study review and R&D briefing event today, featuring Dr. Maurizio Fava, MD, Massachusetts General Hospital & Harvard Medical School, and Dr. Gitte Moos Knudsen, Professor, Chief Neurologist, DMSc, Neurobiology Research Unit, Rigshospitalet and University of Copenhagen, Denmark.

Click here to register for the live webcast. A replay of the event will also be available on the Company’s investor relations website on the Events & Presentations page.

About Cybin

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.

Headquartered in Canada and 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.

Footnotes

1. A p-value indicates statistical significance. Values <0.05 are considered statistically significant and values <0.001 are considered highly statistically significant. Cohen’s d represents size of the effect. An effect size of 2.15 is considered large.
2. All data are preliminary.
3. Stone et al, 2022
4. The advancement of Cybin’s CYB003 program is contingent on Cybin’s ability to continue raising capital under its current and future financing arrangements. No assurances can be given that Cybin will be able to raise the additional capital that it may require for its anticipated future development.