” “At the 3-week primary efficacy endpoint, the reduction in major depressive disorder (“MDD”) symptoms, defined as change from baseline in MADRS total score, was superior in participants assigned to CYB003 compared to the participants who received placebo by 14.08 points (p=0.0005, Cohen’s d=2.15). A p-value indicates statistical significance. Generally, values <0.05 are considered statistically significant and values <0.001 are considered highly statistically significant,” the company said in a press release on Tuesday.

Cybin’s Chief Medical Officer, Amir Inamdar, the chief medical officer at Cybin, said that the “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.” “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, Inamdar.  The company said that the phase 2 clinical trial is assessing the efficacy of the treatment based on the MADRS scale, or the “Montgomery-Asberg Depression Rating Scale” that is used to evaluate the level of depression in a patient.

According to Cybin, the trial showed a “a primary efficacy endpoint of reduction in depression symptoms (change from baseline in MADRS) at week 3 after a single administration.”  “To date, dosing has been completed in all dose cohorts up to 16mg, with a favorable safety and tolerability profile and no treatment-related serious adverse events observed. Interim results from the 12mg dose cohort have demonstrated a statistically significant and clinically meaningful reduction in symptoms of depression with a single dose at three weeks after treatment,” the company said in the press release.

“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.” According to the company, trial participants showed “rapid and statistically significant improvements in depression symptoms observed after single doses of CYB003,” along with improvements “in depression symptoms evident on the day after dosing, reaching a peak 10 days after dosing, and maintained thereafter.

” Moreover, Cybin said that “CYB003 was well tolerated with no drug-related Serious Adverse Events,’ and that all adverse effects “were mild or moderate in intensity and resolved spontaneously without intervention.” Doug Drysdale, the chief executive officer of Cybin, said that the results showcase the potential of CYB003 for patients. He said that the results also pave the way for even more robust trials next year. “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 Drysdale. “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.

” He added: “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.

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