Cybin claims its psychedelic drug maintains remission in depression patients

Cybin has announced promising results for its psilocin analog, CYB003, in treating major depressive disorder (MDD). This marks a significant development as CYB003 potentially offers a more effective solution compared to traditional antidepressants. In a recent Phase 2 trial, two doses of 16 mg CYB003 achieved a 100% response rate on the Montgomery–Åsberg Depression Rating Scale (MADRS) after 12 months, with 71% of patients reaching remission. These findings indicate substantial and lasting benefits, with prior data showing 75% remission at four months, according to Cybin’s chief medical officer, Amir Inamdar.

Currently, the standard treatment for MDD involves selective serotonin reuptake inhibitors (SSRIs). However, only about one-third of patients enter remission after six weeks of daily use, and many experience a dulling of emotions, both positive and negative, which CEO Doug Drysdale describes as feeling like being in "chemical handcuffs." In contrast, CYB003 offers a potentially quicker and more satisfying outcome.

In the Phase 2 study, participants continued with their regular medications while taking CYB003. This allowed them to avoid the difficult process of reducing their usual medication. Drysdale noted that the aim is for patients to eventually discontinue their current drugs once they respond to CYB003. Instead of daily SSRI tablets for years, patients might need just two doses of CYB003 over a year.

The Phase 2 trial specifically evaluated the efficacy of two oral doses of CYB003 – 12 mg or 16 mg – taken twice, three weeks apart. Eight patients completed a 12-month follow-up with the 16 mg dose, seven of whom received two doses while one received a single dose. The treatment was well tolerated, with no serious side effects or reports of suicidality. Common side effects included nausea, headache, and temporary elevated blood pressure, but these were limited to the dosing periods.

Recently, Cybin launched its Phase 3 program for CYB003, which includes three trials. One of these trials will test three groups: two doses of 16 mg, two doses of 8 mg, and two doses of a placebo. The aim is to eliminate expectancy bias, according to Drysdale.

In October, Compass Pathways delayed its anticipated Phase 3 results for COMP360, its psilocybin-based treatment for treatment-resistant depression. In comparison, CYB003 is derived from psilocin, the active component of psilocybin. Drysdale explained that Cybin has removed a metabolic step and enhanced the pharmacokinetics through deuteration, offering potential advantages over Compass' approach.

Overall, Cybin’s CYB003 presents a promising alternative for those suffering from major depressive disorder, potentially providing relief with fewer doses compared to existing antidepressants. The ongoing research and upcoming Phase 3 trials will further determine its efficacy and safety profile.