Christopher Chen

Christopher Chen asked about expectations for the Work Productivity and Activity Impairment (WPAI) metric in the Emerge MDD study, and what Definium is hearing about patient outcomes beyond just MDD symptom alleviation, drawing a comparison to SPRAVATO. He also inquired if time-to-discharge data is being collected and if any shifts from the 6-8 hour monitoring period are observed.

Answer

Robert Barrow, CEO, highlighted the benefit of infrequent dosing for productivity. Dr. Daniel Karlin, Chief Medical Officer, explained WPAI's domains and emphasized that DT120 aims for a 'whole person change' and recovery, not just symptom suppression, based on Phase 2 participant experience. Mr. Barrow confirmed high-granularity time-to-discharge data collection, with structured assessments from hour five and observation through hour eight, but noted more aggregate data is needed before detailed sharing.

Christopher Chen from Robert W. Baird inquired about Definium's expectations for the Work Productivity and Activity Impairment (WPAI) scale in the Emerge MDD trial, contrasting DT120 ODT's potential impact on daily life productivity with observations for SPRAVATO. He also asked if Definium is collecting time-to-discharge data and if any shifts from the 6-8 hour monitoring period are being observed.

Answer

Robert Barrow, CEO, emphasized DT120 ODT's infrequent dosing as a significant advantage for patient productivity compared to SPRAVATO. Daniel Karlin, CMO, explained that WPAI is a key secondary measure, and Definium aims for a "whole person change" and recovery, not just symptom suppression, based on Phase II participant experiences. Mr. Barrow confirmed high-granularity time-to-discharge data collection, with structured assessments from hour five through hour eight, and will share aggregated insights when confident.

Christopher Chen of Baird asked about the operational synergies between the GAD and MDD trials, specifically patient crossover during screening, and requested details on the in-clinic treatment protocol, including provider roles and the distinction from psychotherapy.

Answer

CEO Robert Barrow confirmed that the trials were designed for screening efficiency, allowing patients who screen for GAD but have MDD to easily move into the depression program. Chief Medical Officer Dr. Daniel Karlin clarified that a provider is present to monitor the patient, but training is explicit that their role is assistance, not psychotherapy, with the focus on patient safety.

Christopher Chen from Baird asked to confirm the operational synergy of enrolling patients screened for GAD into the MDD trial if applicable, and requested more detail on the treatment visit, including provider presence and guardrails against psychotherapy.

Answer

CEO Robert Barrow confirmed the trial design allows for efficient crossover from GAD screening to MDD enrollment. CMO Dr. Daniel Karlin explained that during the treatment visit, a provider is present for monitoring and assistance, with explicit training and protocols in place to ensure they do not engage in psychotherapy while the patient focuses on their internal experience.