Generate:Biomedicines Launches Global Phase 3 Trials for AI-Engineered Anti-TSLP Antibody GB-0895 in Severe Asthma
Generate:
Biomedicines announced the initiation of two global Phase 3 clinical trials, SOLAIRIA-1 and SOLAIRIA-2, to evaluate GB-0895, an AI-engineered long-acting monoclonal antibody targeting thymic stromal lymphopoietin (TSLP) in severe asthma patients whose disease remains uncontrolled on current therapies.
The trials will enroll about 1,600 adults and adolescents across more than 40 countries, studying the efficacy of GB-0895 administered subcutaneously every six months over 52 weeks with the primary endpoint of reducing annualized asthma exacerbation rates.
GB-0895 was designed using Generate’s generative biology platform integrating machine-learning and high-throughput experimentation to optimize potency, half-life (approximately 89 days), affinity, and specificity for TSLP, aiming for a long-acting treatment reducing dosing frequency and patient burden.
Phase 1 data presented at the 2025 European Respiratory Society Congress showed GB-0895 was well tolerated with sustained biomarker reductions consistent with TSLP blockade lasting at least six months.
This represents a significant milestone illustrating the potential of programmable biology and AI to rapidly design therapeutic antibodies advancing from discovery to Phase 3 clinical development within four years.
GB-0895 is also under evaluation in a Phase 1 trial for chronic obstructive pulmonary disease (COPD), expanding its clinical potential beyond asthma.