CRED Understanding Clinical Development 2024

08/10/2024

Learning Outcomes: Recap

Following completion of Phase 2: ⚫ Dose selection for Ph 3

⚫ Go/No-decision point for Phase 3 ⚫ Phase 2 data used to design the pivotal Phase III studies: ● Is the proposed effect size clinically relevant (endpoints/commercial value) ● Initial safety profile (AE/RSI) ● Patient population (e.g. mild/moderate/severe) ● Inclusion/exclusion criteria ● Trial design (placebo controlled/active comparator) ● Timing and use of endpoints ● Power calculation, number of patients to be included ● Statistical analysis plan ● Potential upsides – biomarker strategy, companion diagnostic, patient reported outcomes

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