Generate:Biomedicines Initiates Phase 3 Trials for Asthma Antibody GB-0895

Generate:Biomedicines has announced the initiation of two global Phase 3 clinical trials, SOLAIRIA-1 and SOLAIRIA-2, for their AI-engineered GB-0895 antibody. These studies involve about 1,600 patients with severe asthma that remains uncontrolled on existing therapies. GB-0895 aims to reduce asthma exacerbations over 52 weeks by targeting the key inflammation driver, thymic stromal lymphopoietin (TSLP).

GB-0895 is designed to bind TSLP with ultra-high affinity, extended half-life, and high specificity, allowing for biannual dosing. This investigational antibody is also under evaluation for chronic obstructive pulmonary disease (COPD) in a Phase 1 trial.

Phase 1 results showcased at the ERS Congress demonstrated favorable tolerance and dose-proportional pharmacokinetics in subjects, supporting the long-interval dosing strategy. The trials will take place across North America, Europe, Latin America, and Asia Pacific, assessing lung function and quality of life.