Nov 1, 2023

Cybin's CYB003 Marks a Paradigm Shift in Major Depressive Disorder Treatment: Unveiling Unprecedented Phase 2 Efficacy Data

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Tuesday morning, Cybin (NYSE:CYBN) announced positive interim phase 2 data for its CYB003 deuterated psilocybin analog for the treatment of major depressive disorder (MDD). The company lauded the results as “unprecedented” and noted that the interim data readout “shows rapid, robust, and clinically significant reduction of depression symptoms three weeks after a single 12mg dose.”

Interim readout

  • 53.3% of patients responding and 20% of patients in remission (no longer meeting the clinical definition of depression) vs. 0% for placebo.
  • Favorable safety and tolerability profile with no treatment-related serious adverse events at 12 mg dose.
  • Improvements in depression symptoms evident on the day after dosing, reaching a peak 10 days after dosing, and maintained thereafter.
  • Robust and statistically significant reduction in depression symptoms compared to placebo at 3 weeks, with a -14.08 difference in change from baseline in MADRS for CYB003 vs. placebo (p=0.0005).

Overall, the initial takeaway from Cybin’s press release is that this may be the most compelling set of Phase 2 data from any clinical trial involving a psychedelic drug compound. 

Read MedicalGold’s Interview with Cybin CEO Doug Drysdale that was published on September 12th, 2023

Cybin CEO Drug Drysdale offered his take on the interim phase 2 data:

"The overwhelmingly positive interim results for the 12mg dose of CYB003 are extremely encouraging for patients and providers. The efficacy demonstrated at that dosage showed an unprecedented reduction in depressive symptoms compared to currently available treatments.”

And on what’s next for Cybin and CYB003…

"These positive interim safety and efficacy results support progressing to pivotal studies. We plan to request an end of Phase 2 meeting with the FDA in early 2024 to align on Phase 3 trial design, and we are commencing dosing with a capsule formulation of CYB003 in the bioequivalence cohort and further manufacturing of GMP materials that will be dose flexible, patient friendly and commercially scalable. This is an exciting time – not only for Cybin, but for the entire psychedelics sector – as we now have interim results showing a significant improvement in depressive symptoms with a single dose, moving us ever closer to delivering on our mission to improve the treatment landscape across the spectrum of mental health disorders."
~ Drug Drysdale, Cybin CEO

MedicalGold readers might remember that hedge fund legend Steve Cohen’s Point72 hedge fund took an 8.1% stake in CYBN in early September. It turns out there is a reason why Cohen is a hedge fund billionaire, his timing was impeccable:

CYBN (Daily)

CYBN shares opened today’s trading session up nearly 20%, however, some profit taking on the news left CYBN shareholders with a 6.71% gain on the day. Another factor investors should take into account is the $35 million at-the-market equity program the company has had open since August. According to Cybin’s latest financial statements it has roughly $7 million in cash on its balance sheet. With multiple clinical trials ongoing, and a pivotal phase 3 for CYB003 scheduled for early 2024 investors can expect CYBN to fully tap the $35 million ATM. 

About CYB003

Cybin’s proprietary deuterated psilocybin analog CYB003 is fast acting with robust efficacy at low doses. The potential market opportunity for CYB003 in the treatment of depression and other mental health ailments (anxiety, ADHD, etc.) is nothing short of gigantic. Cybin’s stated mission is to revolutionize mental healthcare, today’s results demonstrate a big step forward towards achieving that mission. 


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