Cybin High On Psychedelic-Based CYB003 For MDD

Updated Phase II Data Show Strong Efficacy

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 company outlined the Phase III trial design to investors on 14 March, one day after releasing updated Phase II...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Metsera’s Amylin Analog Stars In Obesity Phase I

 
• By 

Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.

Merck & Co.’s Enlicitide Poised To Be First Oral PCSK9 Inhibitor To Market

 

The company announced positive data from two Phase III trials testing the cholesterol-lowering medicine.

Sanofi Cements RSV Dominance As Merck & Co. Rival Awaits FDA D-Day

 
• By 

The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.

Pipeline Watch: ASCO Dominates Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from R&D

Quick Listen: Scrip’s Five Must-Know Things

 
• By 

In this week's episode: Sanofi’s Blueprint buy; AstraZeneca’s breast cancer resistance results at ASCO; BMS and BioNTech’s big bispecific deal; Kymera’s Dupixent in a pill; and Degron’s CEO on pipeline and strategy.

Otsuka’s IgAN Data Top Some Vera Results, But To What End?

 
• By 

Otsuka bested Vera on Phase III immunoglobulin A nephropathy data for proteinuria, but analysts wonder if the difference is especially meaningful.

ASCO: Kite’s Glioblastoma CAR-T Highlights Solid Tumor Progress

 

The company presented Phase I data for CART-EGFR-IL13Rα2, showing patient responses in the notoriously hard-to-treat and deadly brain cancer.