Cybin Inc. Advances in Psilocybin Research with Completion of Phase 2 Study Enrollment

LOS ANGELES- Cybin Inc. (CYBN) announced the successful enrollment completion in its Phase 2 study of CYB003, a novel deuterated psilocybin analog, which is being assessed for potential treatment benefits in Major Depressive Disorder (MDD).

The final, sixth cohort of the study has seen participants receive either a placebo or a 16mg dose of CYB003. Remarkably, no serious adverse events have been reported even with multiple doses administered. The earlier five cohorts have also yielded positive safety results across varying doses, ranging from 1mg to 12mg.

The Phase 2 study is expected to conclude in early Q4 this year. Topline efficacy results are projected for submission to the FDA, which will guide Cybin’s subsequent pivotal studies. Bolstered by a U.S. patent lasting until 2041, the company is set to launch its multinational Phase 3 study for CYB003 in early 2024.

Adding to its innovation, Cybin is gearing up for a comprehensive EMBARK facilitator training program and a partnership for GMP-compliant capsule production.

The potential for an FDA “Breakthrough Therapy” designation in Q4 2023 further brightens the horizon for CYB003 and Cybin’s endeavors.

Doug Drysdale, CEO of Cybin, expressed his excitement, deeming the Phase 2 enrollment completion as a “significant milestone.” Drysdale believes the research brings them one step closer to comprehending the antidepressant capabilities of this novel psychedelic compound.

The impending acquisition of Small Pharma (DMTTF) is anticipated to bolster Cybin’s intellectual property stance, creating what Drysdale believes could be “the most robust IP portfolio in the sector.” This strategic move is set to amplify Cybin’s potential to usher these groundbreaking therapeutics from the lab to those who need them.

Detailing the ongoing Phase 1/2 trial:

• CYB003’s safety, tolerability, pharmacokinetics, pharmacodynamics, and its psychedelic effects are being evaluated at increasing oral doses across all participants.
• For MDD patients, the study is analyzing the rapid onset of the antidepressant effect and the added benefit of a second dose given three weeks later. An optional evaluation period will discern treatment effect longevity up to 12 weeks.
• Healthy volunteers, on the other hand, are given two doses a week apart, with psychedelic effects assessed post-dose.
• MDD patients receive two doses, three weeks apart, with the assessment of response/remission conducted three weeks after each dose. Notably, those already on antidepressants are allowed to continue their regimen.

As global interest in the therapeutic potential of psychedelics surges, Cybin’s advancements signify a promising trajectory in the realm of mental health treatments.