Cybin’s Breakthrough: Psychedelic Depression Drug CYB003 Sustains 12-Month Symptom Remission in Major Depressive Disorder

Recently, Cybin Inc. (NYSE American:CYBN) announced 12-month efficacy data from its Phase 2 study of CYB003, a proprietary deuterated psilocin drug. The company, focused on revolutionizing mental healthcare, develops next-generation treatments for major depressive disorder (MDD). The Phase 2 results showed unprecedented long-term efficacy, demonstrating sustained symptom remission in MDD patients. CYB003 previously received Breakthrough Therapy Designation from the FDA, expediting its review process. This designation recognizes the drug’s potential for improvement over existing therapies in treating MDD. The results further highlight the drug’s 12-month efficacy in addressing symptoms of the disorder.

At 12 Months, CYB003 Achieves 100% Response Rate with 71% Sustained Remission

Cybin’s clinical trial of CYB003, a psilocybin-derived drug for MDD, demonstrated positive results. The treatment regimen involved two 16 mg doses of CYB003, spaced three weeks apart. These doses showed sustained benefits over 12 months. “We previously reported response and remission rates of 75% at four months. By the 12-month mark, response rates improved to 100% while 71% of participants were still in remission,” Cybin Chief Medical Officer Amir Inamdar said in the release. This suggests that CYB003 offers long-lasting relief, which is uncommon in current MDD treatments. Moreover, patients who received the two doses saw an average improvement of nearly 23 points on the Montgomery–Åsberg Depression Rating Scale (a clinical tool used to measure the severity of a patient’s depression). Cybin noted in the release that the two patients who responded to treatment but were not in remission had MADRS scores of 11. Remission requires a score of 10 or lower. These findings indicate that CYB003 could address a significant unmet need in MDD treatment, offering a potential breakthrough for patients who struggle with ongoing symptoms.

Moreover, Cybin reported no new adverse events during the 12-month follow-up, including no cases of suicidality. In previous data, the company found no treatment-related adverse events six weeks after administering 12 mg or 16 mg doses.

Other biotech companies have faced challenges in advancing antidepressants. Last year, the FDA rejected Sage and Biogen’s zuranolone for MDD, approving it only for postpartum depression. The FDA issued a complete response letter to the companies, stating zuranolone lacked sufficient evidence for MDD approval, to which the agency requested additional studies to support its effectiveness for treating MDD. Also, in 2019, Allergan’s acquisition of Naurex for $560 million faltered when an NMDA receptor modulator failed in a Phase 3 MDD trial. Allergan tested rapastinel as an adjunct therapy for MDD in three Phase 3 studies with 1,510 patients. The drug was well-tolerated but failed to show efficacy compared to placebo on primary and secondary endpoints.

Cybin’s CYB003: Long-Term Data Boosts Market Confidence After Initial Phase 2 Setback

A year ago, Cybin’s initial Phase 2 data for their psilocybin-derived drug, CYB003, failed to impress investors. However, recent long-term data improved investor confidence. The new analysis showed that seven patients who received two 16 mg doses of CYB003 had significant improvement. Twelve months later, their scores on the Montgomery–Åsberg Depression Rating Scale improved by an average of 23 points from baseline. This indicates that the drug had a lasting positive effect on their depression symptoms.

Additionally, this data supports CYB003’s potential as an adjunctive treatment for MDD patients who haven’t responded to first-line antidepressants. The U.S. FDA recently granted CYB003 Breakthrough Therapy Designation, accelerating its review process. Cybin’s CEO, Doug Drysdale, said, “We are quite possibly witnessing a watershed moment in mental health care treatment paradigms and practices.” He emphasized that current treatments, such as esketamine and electroconvulsive therapy (ECT), require up to 36 outpatient visits per treatment cycle. In contrast, CYB003’s two-dose regimen could offer a more patient-friendly, long-lasting alternative.

Retail Investors Turn Extremely Bullish on CYB003, Fueling Optimism for the Future

Following the announcement on November 18, Cybin’s positive results for CYB003 prompted investors to buy the company’s stock. On Monday, the stock price had risen by $1.49 per share, a 12.8% increase from the previous Friday’s close. However, after 10:30 a.m., the stock price began to fall. It gradually returned to pre-surge levels, signaling that the initial excitement around the announcement was short-lived and the price stabilized.

Sentiment for CYB003 among retail investors turned extremely bullish, with many expressing optimism about the company’s future. Some speculated that regulatory support under a Trump administration, with figures like Robert F. Kennedy Jr. as HHS Secretary, could accelerate FDA approval for CYB003. One investor even predicted the stock would soon double to $25. Analyst firms remained optimistic, with Canaccord maintaining a ‘Buy’ rating but lowering its price target from $96 to $86. Meanwhile, Alliance Global Partners raised its target from $6 to $25, reflecting confidence in CYB003’s progress and Phase 3 trials. Still, Cybin’s stock has dropped 19% year-to-date.

Looking Forward: Cybin Launches Phase 3 PARADIGM Program to Assess CYB003’s Global Efficacy and Safety

Cybin is advancing toward key milestones in its clinical pipeline. After aligning with the FDA, the company launched its Phase 3 PARADIGM program. This study will assess CYB003’s efficacy and safety in a broader MDD patient group. Cybin expects to report Phase 2 topline results for CYB004, a treatment for generalized anxiety disorder, by Q1 2025. CEO Doug Drysdale emphasized the company’s commitment to advancing CYB003 towards regulatory approval and commercialization, building on positive clinical data from both programs.

Author

Bernice Lottering