Question · Q3 2022
Jason Shieh, speaking for Patrick Trucchio of H.C. Wainright, asked about the CYB003 trial's structure, including the transition from Phase I to IIa and the baseline characteristics of patients. He also requested an update on the EMBARK program's investigator-initiated trial at the University of Washington, its protocol, and how learnings would apply to the CYB003 study.
Answer
CEO Douglas Drysdale explained that the CYB003 trial is a nested study that will move directly into MDD patients, bypassing a separate healthy volunteer cohort and saving time. Patients will have moderate to severe MDD, measured by the MADRS scale. He described the University of Washington study as a valuable 'test run' for the EMBARK psychotherapy model, which is currently enrolling and uses a protocol of three prep and up to three integration sessions. Learnings from this will directly inform and optimize the deployment of EMBARK in the larger CYB003 trial.