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FDA Grants Breakthrough Status to Cybin’s CYB003 for Major Depressive Disorder

FDA Grants Breakthrough Status

Cybin, a clinical-stage biopharmaceutical company, has received FDA Breakthrough Therapy Designation (BTD) for CYB003, a novel deuterated psilocybin analog designed to treat Major Depressive Disorder (MDD).

This designation acknowledges CYB003’s potential to revolutionize depression treatment, addressing a significant unmet need affecting millions globally. In a phase 2 trial, CYB003 demonstrated positive topline results:

  1. Patients receiving two doses of 12 mg or 16 mg experienced sustained reductions in MADRS scores, with a mean decrease of approximately 22 points from baseline.
  2. Notably, 75% of those on 16 mg achieved a 50% or greater improvement in MADRS scores, with 60% of patients on 12 mg and 75% on 16 mg in remission following 2 doses.
  3. CYB003 demonstrated a favorable safety profile, with no serious drug-related adverse events reported.

With depression’s pervasive impact and the limitations of current treatments, CYB003’s breakthrough status heralds a promising new era in mental health therapeutics.

READ the full press release for deeper insights.