Drug Discovery and Development

Psilocybin analog leads to 79% of remission in mid-stage depression trial

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CybinAfter only two doses, nearly eight out of ten participants in a phase 2 trial experienced remission from major depressive disorder (MDD) at six weeks, highlighting the potential of Cybin’s deuterated psilocybin analog, CYB003.

In 2021, an estimated 21.0 million adults in the United States had at least one major depressive episode, representing 8.3% of all U.S. adults, according to NIH.

While estimates vary for remission rates with traditional antidepressants, one study found a remission rate of 37% after the first treatment and 31% after the second. Traditional antidepressants also have the disadvantage of being slow acting, often taking 6 to 8 weeks before a detectable effect is observable. Complicating matters further is that patient adherence to traditional antidepressant therapy often remains poor with one study showing that 50% or more of patients fail to take antidepressants as prescribed. Another review found that 28% of patients stop antidepressant treatment within the first month and 44% discontinue within 3 months of beginning therapy. The same article noted that recurrence and relapse rates for depression are up to 80% while treatment failures range from 40 to 60%.

In contrast, CYB003 showed not only a high remission rate but also rapid and significant symptom reduction after just a single dose. The deuterated psilocybin analog was associated with a mean reduction of 14 points in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared to placebo at 3 weeks. After the second dose of CYB003, patients showed a further improvement of 5.8 points on the MADRS total score at 6 weeks.

Bar graph displaying sustained and incremental responses and remission rates with a second dose, showing percentage of patients with a reduction in MADRS scores by at least 50% and those achieving remission with MADRS scores less than 10. Two dosages, 12 mg and 16 mg, are compared at Day 21 and Day 42. At Day 21, 53% responded to 12 mg and 44% to 16 mg; at Day 42, these increased to 79% and 75% respectively. For remission, 20% achieved it with 12 mg and 22% with 16 mg at Day 21, increasing to 79% and 50% respectively by Day 42.

[Data from Cybin]

Also supporting the efficacy of CYB003 was the substantial effect size in the study, with a Cohen’s d value exceeding 2, indicating a very large effect. Conversely, newer antidepressants have an effect size of roughly 0.24 (95% CI 0.18 to 0.30), while the journal-based effect size is slightly higher at 0.29 (95% CI 0.23 to 0.36), according to a study in PLOS Medicine.

Taboo for decades, psychedelics such as psilocybin could emerge as a respectable treatment for depression in the coming years as comparable studies in the field of psychedelic therapy lend further credence to Cybin’s most recent findings. For instance, Johns Hopkins Medicine reported enduring antidepressant effects from psilocybin-assisted therapy, with benefits lasting up to a year for many patients. Compass Pathways’ phase 2b trial of COMP360 psilocybin therapy for treatment-resistant depression also showed a significant reduction in depressive symptoms, with rapid and sustained improvements up to 12 weeks, but also noted treatment-emergent serious adverse events in some participants, including suicidal behavior, particularly at higher dosages.

Cybin’s phase 2 study found CYB003 to have “extraordinary topline safety and efficacy data,” in the words of CEO Doug Drysdale. With no treatment-related serious adverse events reported at both the 12 mg and 16 mg doses, the ___

Cybin’s intention to submit topline data to the FDA and request an end of Phase 2 meeting in Q1 2024, as well as their plans for a 12-week durability data report from the Phase 2 CYB003 study, and the commencement of a Phase 3 study by the end of Q1 2024.

Following the results from the study, Cybin plans to submit the topline data from the CYB003 study to the FDA. The company is also scheduling an end-of-Phase-2 meeting in the first quarter of 2024. In addition, Cybin plans to release a 12-week durability data report from the same study. The company has a planned phase 3 study slated to commence by the end of Q1 2024.

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About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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