Cybin Inc. (CYBN:NYSE American; CYBN:NEO) has announced positive 12-month results from its Phase 2 study of CYB003, a deuterated psilocin analog for adjunctive treatment of major depressive disorder (MDD), demonstrating significant and sustained efficacy. The study revealed that 100% of participants achieved a response, with 71% reaching remission after receiving two 16-milligram doses of CYB003 administered three weeks apart.
Durable Efficacy Confirmed
Chief Medical Officer Dr. Amir Inamdar highlighted the findings, stating, "We are highly encouraged that our approach to treating MDD patients with two 16-milligram doses of CYB003, three weeks apart, has demonstrated consistent, robust, and sustained treatment benefits through to the 12-month follow-up." He noted the improvement from 75% response and remission rates at four months to 100% and 71%, respectively, at 12 months, validating the dosing regimen and confirming CYB003's durable effects.
Regulatory and Clinical Advancement
CYB003 has received Breakthrough Therapy Designation from the FDA, potentially expediting its review. Cybin's CEO, Doug Drysdale, emphasized the potential of CYB003 to revolutionize mental health care by shifting from chronic daily treatments to less frequent dosing regimens, reducing the burden on patients and treatment centers compared to existing treatments like esketamine, electroconvulsive therapy, and transcranial magnetic stimulation.
The study enrolled participants who received either two active doses of CYB003 or a combination of active and placebo doses. Among those who received two 16-milligram doses, all participants were classified as responders, achieving a 50% or greater reduction in MADRS scores. Of these, 71% were in remission, defined by MADRS scores of 10 or lower. CYB003 also demonstrated a favorable safety profile with no new adverse events reported during the 12 months.
Building on these results, Cybin is advancing CYB003 into Phase 3 trials as part of its Paradigm program, evaluating the therapy in a larger population of MDD patients. These trials are expected to begin before the end of 2024.
Psilocybin in Mental Health Research
Psilocybin, found in over 100 mushroom species, is a focal point in mental health research. A study reported by Inverse on September 24 examined psilocybin's effects on body dysmorphic disorder (BDD), revealing that a single 25-milligram dose significantly improved neural connectivity, particularly between areas of the brain involved in emotional processing and executive function. This increased connectivity correlated with a measurable reduction in BDD symptoms.
The National Institute of Health has detailed psilocybin's unique pharmacological properties and its interaction with serotonin receptors, particularly 5-HT2A, located in the brain's thalamus and cortex. This interaction alters sensory input and perception and may help address abnormalities in sensory processing often associated with mental health disorders such as depression and anxiety. Research has also indicated that psilocybin's ability to facilitate neuroplasticity enhances the brain's capacity to form new connections.
Market and Analyst Perspectives
Alliance Global Partners reiterated its Buy rating for Cybin on November 14, emphasizing the potential of CYB003 for MDD. Analyst James Molloy highlighted the durability of the Phase 2 results, noting an average improvement of 13.75 points on MADRS (12mg and 16mg cohorts pooled), which is statistically significant from placebo. Alliance projected a potential NDA submission by 2027, with a price target raised to US$25, valuing CYBN at US$16 per share and assigning a US$2 billion peak sales estimate by 2036.
Bloom Burton & Co. maintained a Buy rating with a speculative risk on Cybin on November 1, raising their 12-month price target to US$114.00, up from US$3.00, following the recent share consolidation. Analyst David Martin emphasized that Cybin has refined its Phase 3 PARADIGM program based on updated FDA guidance, reducing risks of functional unblinding. He stated, "Cybin’s trial design in which CYB003 is added as an adjunct to current meds offers a significant advantage over competitors requiring medication washouts."
The firm estimated a 55% probability of approval and US$2.1 billion in peak sales, basing their valuation on a 6x multiple of projected sales discounted at 12%.
