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Cybin Inc
Symbol CYBN
Shares Issued 405,910,711
Close 2023-11-29 C$ 0.64
Market Cap C$ 259,782,855
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Cybin boasts about CYB003 phase 2 safety, efficacy data

2023-11-30 10:34 ET - News Release

Mr. Doug Drysdale reports

CYBIN REPORTS POSITIVE TOPLINE DATA FROM PHASE 2 STUDY OF CYB003 IN MAJOR DEPRESSIVE DISORDER WITH 79% OF PATIENTS IN REMISSION AFTER TWO 12MG DOSES

Cybin Inc. has released positive phase 2 top-line safety and efficacy data for CYB003, its proprietary deuterated psilocybin analogue, being developed for the treatment of major depressive disorder (MDD).

"We are delighted to share that CYB003 achieved the primary efficacy end point 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 four out of five patients in remission from their depression at six 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 three-week primary efficacy end point, a single 12-milligram dose of CYB003 showed a rapid, robust and highly statistically significant improvement in depression symptoms compared to placebo, with a minus-14.08-point difference in change from baseline in MADRS [Montgomery-Asberg depression rating scale]. This translated into a very large effect size. Similar significant and robust effects were also seen with a single 16 mg 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 16 mg dose and were also highly statistically significant. When data from 12 mg and 16 mg are pooled, these robust effects are maintained. Further, with two doses, response and remission rates in excess of 75 per cent were observed with CYB003 (12 mg). 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 top-line efficacy data:

  • Rapid and large improvements in symptoms of depression observed after single doses of CYB003:
    • An average of 13.75 points on MADRS (12 mg and 16 mg cohorts pooled) which is statistically significant from placebo at three weeks.
  • 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 (12 mg) at six weeks;
    • 79 per cent of patients were responsive to treatment and 79 per cent of patients were in remission from their depression at six weeks after receiving two doses of CYB003 (12 mg).
  • Magnitude of improvement far superior compared with approved antidepressants and recently reported data with other psychedelics:
    • Effects translate into unprecedented effect size;
    • These results compare favourably with 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 versus placebo.
  • 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 top-line 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 Mr. Drysdale.

Coming milestones for the CYB003 program

Cybin plans to submit top-line data to the U.S. 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 are anticipated in Q1 2024. Recruiting for a CYB003 phase 3 study is anticipated to begin by the end of Q1 2024.

Phase 2 top-line study review and R&D briefing to be held today at 10 a.m. ET in New York

Cybin's leadership team is hosting a phase 2 top-line study review and research and development briefing event today, featuring Dr. Maurizio Fava, MD, Massachusetts General Hospital and Harvard Medical School, and Dr. Gitte Moos Knudsen, professor, chief neurologist, DMSc, neurobiology research unit, Rigshospitalet and University of Copenhagen, Denmark.

A replay of the event will also be available on the company's investor relations website on the events and presentations page.

About Cybin Inc.

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 health care 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 analogue for the treatment of major depressive disorder, and CYB004, a proprietary deuterated DMT (N,N-dimethyltryptamine) molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.

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