Question · Q3 2022
Sepehr Manochehry of Eight Capital questioned the design of the CYB003 trial, asking about the type of placebo to be used, blinding controls, and patient inclusion criteria. He also asked if there was potential for a post-hoc analysis for Alcohol Use Disorder (AUD) and inquired about the status of any pre-IND meetings with the FDA.
Answer
CEO Douglas Drysdale clarified that the trial will use a true placebo and will be fully blinded. A key aspect of the inclusion criteria is that patients with moderate to severe depression will remain on their SSRIs, positioning CYB003 as an adjunctive therapy. He noted that MDD and AUD are distinct populations, precluding a post-hoc analysis. He also confirmed that while they have met with other regulators, they do not expect a pre-IND meeting with the FDA before the Q2 submission.