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Cybin High On Psychedelic-Based CYB003 For MDD

Updated Phase II Data Show Strong Efficacy

 
• By Jessica Merrill

The company will initiate a Phase III program in mid-2024, testing the deuterated psilocybin analog as an adjunctive treatment for depression on top of SSRIs.

brain puzzle
Cybin is moving a new drug into Phase III for depression • Source: Shutterstock

Cybin Inc. will initiate a Phase III program for its deuterated psilocybin analog CYB003 for major depressive disorder (MDD) after demonstrating encouraging efficacy in Phase II studies and aligning with the US Food and Drug Administration on the Phase III trial design. The company aims to uniquely position CYB003 as the only psychedelic-based drug for use on top of standard therapy, selective serotonin-reuptake inhibitors (SSRIs).

Key Takeaways
  • Cybin CEO Doug Drysdale updated investors on the Phase III development timeline and new Phase II durability data for CYB003.
  • The deuterated psilocybin analog is being developed as an adjunctive therapy to current SSRIs for major depressive disorder

The company outlined the Phase III trial design to investors on 14 March, one day after releasing updated Phase II durability data and announcing the FDA

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