Sommerville, Massachusetts, technology company Generate:Biomedicines has announced plans to initiate two global phase 3 clinical trials using artificial intelligence (AI) to evaluate a long-acting anti-thymic stromal lymphopoietin (TSLP) antibody. The trial involves integrating data from existing trials, SOLAIRIA‑1 and SOLAIRIA‑2, to evaluate GB‑0895, its proprietary AI-engineered model that blocks TSLP. TSLP is an epithelial cell-derived cytokine that initiates and amplifies airway inflammation in asthma.
In a company press release, Generate:Biomedicines said the combined trials will enroll approximately 1,600 patients with severe asthma across more than 40 countries, with the goal of reducing asthma exacerbations over a 52-week period.
“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.”
According to Nally, GB‑0895 represents a breakthrough in respiratory medicine as the first AI-engineered, long-acting monoclonal antibody targeting TSLP, a key driver of airway inflammation. The therapy is optimized for ultra-high-affinity binding, extended half-life and high specificity, and enables dosing every six months to ease treatment burden for patients.
Generate:Biomedicines presented phase 1 results at the European Respiratory Society Congress 2025, demonstrating that GB‑0895 was well tolerated in 96 participants with mild to moderate asthma. Additionally, it demonstrated an 89-day half-life and sustained biomarker reductions for at least six months. The company reported that its findings supported the six-month dosing schedule now being tested in phase 3.
“Despite significant advances in respiratory medicine, severe asthma remains difficult to control for many people,” said Laurie Lee, MD, chief medical officer for immunology and 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.”
The SOLAIRIA program will compare GB‑0895 (300 mg subcutaneous every six months) to placebo, assessing exacerbation rates, lung function, symptom control and quality of life. GB‑0895 is also under investigation for chronic obstructive pulmonary disease (COPD).
