Generate:Biomedicines Starts Phase 3 Trials for AI-Engineered Asthma Drug GB-0895
Generate:Biomedicines plans to launch two global Phase 3 trials for GB-0895, a monoclonal antibody they built using AI to treat severe asthma. The company detailed this in a press release on December 1, 2025. Endpoints News called it a sign that AI biotechs are entering large clinical trials, and STAT News highlighted the drug in their biotech roundup the next day. Boston Business Journal and Morningstar also covered the news.
Trial Details
The trials, named SOLAIRIA-1 and SOLAIRIA-2, will test GB-0895 against placebo in about 1,600 adults and adolescents with severe asthma not controlled by current treatments. Generate expects to run them across more than 40 countries in North America, Europe, Latin America, and Asia Pacific.
- Duration: 52 weeks
- Dose: 300 mg subcutaneous injection every six months
- Main goal: Cut the annualized rate of asthma exacerbations
- Other measures: Lung function, symptom control, quality of life
More info at www.solairia.com, per the press release.
About GB-0895
GB-0895 targets thymic stromal lymphopoietin (TSLP), a protein that drives airway inflammation in asthma. Generate used their machine-learning platform plus lab tests to boost its binding strength, extend its half-life, and keep it specific. The U.S. Patent and Trademark Office granted Patent No. 12,110,324 for it.
CEO Mike Nally said in the release: “Advancing GB-0895 into Phase 3 marks an important step for Generate and for the field. It shows how an antibody engineered with AI can achieve a strong profile and reach Phase 3 in just four years.”
Chief medical officer Laurie Lee added: “Severe asthma is hard to control for many. These trials show our commitment to patients and our platform’s ability to tackle chronic lung issues.”
Phase 1 Results
Earlier this year at the European Respiratory Society Congress in Amsterdam, Dave Singh from the University of Manchester shared Phase 1 data on 96 people with mild to moderate asthma. GB-0895 proved safe across doses from 10 mg to 1,200 mg, showed dose-proportional blood levels with an 89-day half-life, and cut inflammation markers for at least six months. Full slides are on Generate’s site.
GB-0895 is also in Phase 1 for COPD.
Generate:Biomedicines
Flagship Pioneering started the Somerville, Mass.-based company in 2018. Their platform mixes AI, protein engineering, and medicine to create treatments for tough targets. Contact: Megan McLaughlin at megan.mclaughlin@generatebiomed.com.
