A groundbreaking first-in-human trial has revealed that an inhaled anti-thymic stromal lymphopoietin (TSLP) therapy shows significant promise for individuals with moderate-to-severe asthma. TSLP, a key cytokine in airway inflammation, presents an attractive target for new treatments.
This Phase I randomized controlled trial evaluated AZD8630/AMG 104, an inhaled anti-TSLP antibody fragment. The study involved 181 healthy adults and asthma patients, assessing safety, pharmacokinetics, and pharmacodynamics. The therapy was well-tolerated with a low incidence of anti-drug antibodies.
Critically, in asthma patients, the highest dose achieved a 23% reduction in fractional exhaled nitric oxide (FeNO), a key biomarker of airway inflammation, at Day 28 compared to placebo. This confirmed effective target engagement and biological activity.
These findings suggest inhaled anti-TSLP therapy can directly modulate airway inflammation with a favorable safety profile. While further studies are needed to confirm long-term clinical outcomes, this novel approach could reshape the delivery of biologic treatments in respiratory medicine.