Generate:Biomedicines ("Generate") announced it plans to initiate two global Phase 3 clinical trials, SOLAIRIA-1 and SOLAIRIA-2, evaluating GB-0895 in approximately 1,600 adults and adolescents with severe asthma whose disease remains inadequately managed on current therapies. GB-0895 is an investigational, long-acting monoclonal antibody engineered with AI to target thymic stromal lymphopoietin (TSLP), a key driver of airway inflammation. These studies will evaluate the efficacy of GB-0895 in reducing clinically significant asthma exacerbations over 52 weeks, the primary objective for both trials.

GB-0895 is an antibody optimized using AI to achieve ultra-high-affinity TSLP binding, extended half-life, and high specificity. It is being developed as a long-acting therapy designed for dosing every six months to help reduce the treatment burden for people with severe asthma. GB-0895 is also being evaluated in a Phase 1 clinical trial in chronic obstructive pulmonary disease (COPD).

"Advancing GB-0895 into Phase 3 marks an important milestone for Generate and for the field," said Mike Nally, chief executive officer of Generate:Biomedicines. "It demonstrates the potential of programmable biology to design optimal molecular solutions for patients with unprecedented speed and intentionality — in this instance, showing how an antibody engineered with AI can achieve a potentially best-in-class profile and advance into Phase 3 studies within just four years."

"Despite significant advances in respiratory medicine, severe asthma remains difficult to control for many people," said Laurie Lee, MD, chief medical officer for immunology & inflammation at Generate:Biomedicines. "Initiating Phase 3 studies for GB-0895 reflects both our commitment to people living with severe asthma and the strength of our platform to bring forward medicines that could reduce the burden of chronic respiratory disease."

Phase 1 Results Presented at ERS 2025
Dave Singh, MD, professor of clinical pharmacology and respiratory medicine at the University of Manchester and medical director at the Medicines Evaluation Unit, presented Phase 1 data for GB-0895 at the European Respiratory Society (ERS) International Congress 2025 in Amsterdam. In this study of 96 people with mild to moderate asthma, GB-0895 was generally well tolerated across a wide dose range (10 mg to 1,200 mg), demonstrated dose-proportional pharmacokinetics with an approximately 89-day half-life, and produced sustained reductions in key biomarkers consistent with blocking TSLP for at least six months. These data support the six-month dosing schedule now being evaluated in the Phase 3 SOLAIRIA program.