Cybin Reports Positive Topline Results in Depression Study

Cybin Inc. (NYSE American: CYBN) has reported its unaudited financial results for its third quarter ended December 31, 2023 and highlighted positive Phase 2 topline efficacy and safety data for CYB003, in the treatment of Major Depressive Disorder (MDD). The study achieved its primary efficacy endpoint, demonstrating a 79% remission rate from depression.

Doug Drysdale, Chief Executive Officer of Cybin commented on the results, saying, “During the past three months, we have continued to make exciting progress with positive topline data from our CYB003 and DMT programs. The data collected from our clinical trials forms the foundation of our next set of value-creating milestones, as we advance our key programs this year. For CYB003, the three-month Phase 2 efficacy data is expected in Q1 and will provide insights into the durability of treatment effect in MDD.”

The company is working towards initiating a Phase 3 multisite trial of CYB003 for MDD, and with FDA clearance, it is progressing to a Phase 2a study of CYB004 for the treatment of Generalized Anxiety Disorder (GAD).

Highlights

Cybin received clearance from the FDA for its investigational new drug (IND) application for CYB004, paving the way for a Phase 2a study in GAD.

The company also completed Phase 1 studies of intravenous CYB004 and IM and IV SPL028 and reported positive topline safety, pharmacokinetic and pharmacodynamic data. CYB004 demonstrated robust and rapid onset of psychedelic effects at lower doses compared to native N,N-dimethyltryptamine (DMT), suggesting potential as a short-acting, scalable treatment. It was found to be well-tolerated with no serious adverse events.

During the period, the company strengthened its IP portfolio with more than 50 granted patents and over 170 pending applications.

About Cybin

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens. Cybin is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary dDMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.

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Cybin Reports Positive Topline Results in Depression Study

Catie Corcoran

Biotech Editor