Cybin has received breakthrough therapy designation from the FDA for its psilocybin analog (CYB003) therapy for the treatment of major depressive disorder (MDD), the biopharmaceutical company said in a news release.1 The company also announced positive 4-month durability data from a phase 2 trial of CYB003.
CYB003 is a proprietary deuterated psilocybin analog developed by Cybin. It is a new chemical entity and is part of a family of molecules called indolamines, which are related to psilocybin. The breakthrough therapy designation was granted based on phase 2 trial data of CYB003 that demonstrated a statistically significant improvement in depression symptoms at 4 months that were superior to approved antidepressants and data on other psychedelics.
Key Takeaways
- Cybin's psilocybin analog therapy, CYB003, has received breakthrough therapy designation from the FDA for the treatment of major depressive disorder (MDD). This designation underscores the therapy's potential to address unmet needs in MDD treatment.
- The phase 2 trial of CYB003 demonstrated promising results, with statistically significant improvements in depression symptoms sustained for up to 4 months.
- CYB003 offers a novel approach to MDD treatment by providing robust and sustained symptom relief with intermittent dosing, without the need for daily medication.
“It is a testament to the hard work and dedication of the entire Cybin team that we have accomplished so much so quickly,” Doug Drysdale, CEO of Cybin said in a release.1 “The granting of Breakthrough Therapy Designation by the FDA underscores the potential of CYB003 to fill a gap in the treatment landscape for MDD and serves to expedite and de-risk our development program going forward. This designation provides for a streamlined review process and enhanced engagement with the FDA.”
READ MORE: FDA Grants Breakthrough Therapy Designation to LSD-Based Treatment for Generalized Anxiety Disorder
The phase 2 trial was a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of multiple doses of CYB003 in healthy participants with and without MDD. The study found that 2 doses of either 12 mg or 16 mg of CYB003 provided robust and sustained improvements in depression symptoms. Of the participants, 75% responded after 2 doses of 16 mg.
Additionally, 60% of patients on 12 mg and 75% on 16 mg achieved remission from depression following 2 doses. CYB003 was also found to be well tolerated with no serious adverse events. All adverse events were reported to be either mild or moderate in intensity and there were no discontinuations due to adverse events.
