Breaking news as Cybin’s psilocybin program for Major Depressive Disorder has been granted FDA Breakthrough Designation. 

The FDA continues to show support for psychedelic medicine by giving another program its special Breakthrough Designation status. Just last week, MindMed’s LSD program for anxiety was given FDA Breakthrough Designation, followed by today’s news that Cybin’s psilocybin CYB003 program was also receiving FDA support.

CYB003 is Cybin’s novel psilocybin analog, developed to have unique characteristics such as faster onset time and shorter duration compared to classic psilocybin. The compound has shown positive results in its recent Phase 2 trial, with early data showing significant remission rates and newly released 4 month results demonstrating a striking 75% remission rate in participants who received two 16 mg doses of CYB003.(1)

These remission rates far outperform any current treatment options for depression and have led the FDA to put its support behind the program. 

Four-Month Efficacy Data for CYB003 (from Cybin’s press release): 

Robust and sustained improvements in symptoms of depression with two doses of 12 mg or 16 mg of CYB003:
  • Mean reduction from baseline in the MADRS total score was approximately 22 points from baseline in both dosing cohorts.
  • Approximately 75% of the patients were responders (>/= 50% improvement in MADRS scores) following two doses of 16mg.
  • 60% of patients on 12 mg and 75% on 16 mg were in remission from depression following 2 doses (MADRS score </= 10).
Safety and tolerability:
  • CYB003 was well tolerated with no drug-related serious adverse events.
  • All adverse events were mild or moderate in intensity.
  • No incidents of suicidal ideation or behavior.
  • No discontinuations due to adverse events.

“The sustained reduction in depression symptoms at the four-month mark after just two doses of CYB003 is a critical milestone that demonstrates the durability of the response. It also paves the way for a change in the treatment paradigm for MDD. Unlike currently approved adjunctive treatments which require chronic, daily dosing, CYB003 allows for intermittent dosing without the challenges of withdrawing patients from their existing medications,” stated Amir Inamdar, Chief Medical Officer of Cybin

– Amir Inamdar, Chief Medical Officer of Cybin

Breakthrough Designation Could Accelerate FDA Approval

FDA Logo

FDA Breakthrough Therapy Designation is granted to programs that aim to treat a serious condition and that have demonstrated a substantial potential improvement over available therapies. It can speed up the review and approval process, giving access to “Fast Track” features such as accelerated timelines and providing companies with guidance from FDA managers. 

“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,” said Doug Drysdale, CEO of Cybin, in today’s announcement. “This designation provides for a streamlined review process and enhanced engagement with the FDA.

According to Cybin, this is the first known Breakthrough Status granted by the FDA for psychedelic-based therapy for the treatment of Major Depressive Disorder, highlighting the FDA’s increasingly positive view on the potential of psychedelic medicine therapies.

Cybin now plans to launch a Phase 3 multinational study of CYB003 in mid-2024. 

In related news, Cybin also announced a substantial capital raise this morning, with a private placement of US$ 150 million. The raise included the participation of several major biotech investors and will help the company fund the upcoming Phase 3 trial.

This material is not intended as a replacement or substitute for any legal or medical advice. Always consult a medical professional about your health needs. Psychedelics are widely illegal in the United States, and readers should always be informed about local, state, and federal regulations regarding psychedelics or other drugs.

  1. Cybin Inc. (March, 2024). Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive. Disorder