- Interim readout shows rapid, robust, and clinically significant reduction of depression symptoms three weeks after a single 12mg dose, with an unprecedented mean -14 point Montgomery-Asberg Depression Rating Scale (“MADRS”) score reduction from baseline between CYB003 (12mg) vs. placebo (p= 0.0005)
- Robust response and remission three weeks after single dose, with 53.3% of patients responding and 20% of patients in remission (no longer meeting the clinical definition of depression) vs. 0% for placebo
- Favorable safety and tolerability profile with no treatment-related serious adverse events at 12 mg dose
- Company to host conference call to discuss CYB003 interim results on Wednesday, November 1, 2023 at 11:00 a.m. ET
Cybin, a clinical-stage biopharmaceutical company dedicated to advancing mental healthcare through innovative next-generation psychedelic treatments, has unveiled Phase 2 interim results for CYB003, their proprietary deuterated psilocybin analog. These findings showcase a remarkable and swift reduction in symptoms of depression, which persisted for three weeks following a single 12mg dose when compared to a placebo. At the crucial 3-week primary efficacy endpoint, the reduction in symptoms of major depressive disorder (MDD), as measured by the change from the baseline MADRS total score, was notably superior in participants who received CYB003 compared to those who were administered a placebo. This difference was substantial, registering at 14.08 points, a result with a high degree of statistical significance (p=0.0005, Cohen’s d=2.15).
The ongoing Phase 2 clinical trial is employing the MADRS scale to assess efficacy, with the primary endpoint being the reduction in depression symptoms (change from baseline in MADRS) at the three-week mark following a single administration. It’s worth noting that dosing has already been completed across all dose cohorts up to 16mg. Importantly, the treatment exhibited a favorable safety and tolerability profile, with no treatment-related serious adverse events detected. These interim results from the 12mg dose cohort demonstrate a substantial and clinically meaningful reduction in depression symptoms after just a single dose, promising potential breakthroughs in the treatment of depression and potentially opening new avenues in mental healthcare. Further research and the full results of this trial will undoubtedly be awaited with great anticipation.
“The overwhelmingly positive interim results for the 12mg dose of CYB003 are extremely encouraging for patients and providers. The efficacy demonstrated at that dosage showed an unprecedented reduction in depressive symptoms compared to currently available treatments,” said Doug Drysdale, Chief Executive Officer of Cybin. “With these encouraging results in hand, we look forward to sharing the full complement of topline data later this quarter, and 12-week durability data in the first quarter of 2024. Our planning continues as we prepare for a larger international, multisite Phase 3 trial in early 2024 to further evaluate the safety and efficacy of CYB003 in people suffering from MDD.”
The MADRS is a 10-item, clinician-administered scale designed to measure overall severity of depressive symptoms in subjects with MDD. It is widely used in clinical trials and accepted by regulatory authorities worldwide as a measure of symptoms of depression. The MADRS includes items ranging from sadness of mood, reduction in sleep and appetite, to difficulties in concentration, anhedonia, and negative and suicidal thoughts that are scored from 0 to 6 giving a total score ranging from 0 to 60. Typical score ranges for severity are: 0-6 normal; 7-19 mild; 20-34 moderate; and >34 severe depression. In the CYB003 study, mean baseline total scores on the MADRS were 32.6 and 33.3 in the active and placebo groups, respectively.
Summary of CYB003 12mg interim efficacy data at three weeks:
Rapid and statistically significant improvements in depression symptoms observed after single doses of CYB003:
- Improvements in depression symptoms evident on the day after dosing, reaching a peak 10 days after dosing, and maintained thereafter.
- Robust and statistically significant reduction in depression symptoms compared to placebo at 3 weeks, with a -14.08 difference in change from baseline in MADRS for CYB003 vs. placebo (p=0.0005)
Robust response (≥50% reduction in MADRS) and remission (MADRS scores ≤10) rates at three weeks after single dose:
- 53.3% response rate for CYB003 (12mg) vs. 0% for placebo
- 20.0% remission rate for CYB003 (12mg) vs. 0% for placebo
Safety and tolerability:
- CYB003 was well tolerated with no drug-related Serious Adverse Events
- All Adverse Events were mild or moderate in intensity and resolved spontaneously without intervention
“These positive interim safety and efficacy results support progressing to pivotal studies. We plan to request an end of Phase 2 meeting with the FDA in early 2024 to align on Phase 3 trial design, and we are commencing dosing with a capsule formulation of CYB003 in the bioequivalence cohort and further manufacturing of GMP materials that will be dose flexible, patient friendly and commercially scalable. This is an exciting time – not only for Cybin, but for the entire psychedelics sector – as we now have interim results showing a significant improvement in depressive symptoms with a single dose, moving us ever closer to delivering on our mission to improve the treatment landscape across the spectrum of mental health disorders,” concluded Drysdale.
Cybin’s Chief Medical Officer, Amir Inamdar said, “Mental health disorders affect almost 1 billion people worldwide. Comorbid MDD occurs widely in medical and psychiatric disorders, including anxiety disorders and post-traumatic stress disorder. These interim results, together with emerging data from a number of academic studies, suggest that CYB003 may have therapeutic efficacy in range of mental health conditions.”