Designing Trials for Type-2 Inflammation as a Systemic Construct: Rethinking Single-Organ Drug Development
- Re-engineering development programmes to demonstrate efficacy across interconnected type-2–driven diseases (dermatology, pulmonology, allergy, GI), avoiding siloed organ-by-organ strategies that dilute evidence and delay approval
- Determining the regulatory bar for cross-disease indications, including lessons from countries like Spain that have granted Type-2 inflammation approvals and what constitutes sufficient evidence of systemic immune normalisation
- Redefining recruitment and endpoint strategy by identifying shared mechanistic markers, designing trans-organ inclusion criteria, and crafting commercial and medical narratives that communicate a unified systemic mechanism