Global Trials Will Test AI-Engineered Antibody for Severe Asthma

Therapeutics company Generate:Biomedicines plans to begin two Phase 3 clinical trials evaluating its antibody GB-0895 in patients with severe asthma who remain uncontrolled on current treatments. The studies will enroll about 1,600 participants across more than 40 countries, including Mexico. 

Mike Nally, CEO, Generate:Biomedicines, says the advancement reflects the company’s effort to use programmable biology to design targeted molecules. “This advancement demonstrates the potential of programmable biology to design optimal molecular solutions for patients with unprecedented speed and intentionality,” he says in a press release. 

Severe asthma continues to present treatment challenges despite expanded therapeutic options and improved clinical guidelines. Many patients do not reach adequate disease control, and asthma remains a major contributor to chronic respiratory morbidity worldwide. According to Infomed, over 300 million people globally live with asthma, and most also experience allergic rhinitis symptoms. Allergic diseases overall affect millions, with estimates from the WHO indicating that over 30% of the global population may be affected by at least one allergic condition.

GB-0895 is a monoclonal antibody designed using Generate:Biomedicines’ machine-learning platform to target thymic stromal lymphopoietin (TSLP), an epithelial-derived cytokine involved in airway inflammation. The antibody has been optimized for high affinity, extended half-life and specificity, which may enable dosing every six months. The therapy is also being evaluated in a Phase 1 study for chronic obstructive pulmonary disease.

The SOLAIRIA-1 and SOLAIRIA-2 trials will assess whether GB-0895 can reduce the annualized rate of clinically significant asthma exacerbations over 52 weeks. Each trial includes one group receiving 300mg of GB-0895 subcutaneously every six months and one receiving placebo. Additional evaluations include lung function, symptom control, and quality-of-life outcomes. Although the studies share nearly identical designs, the geographic distribution of participants varies to broaden data representation.

Generate:Biomedicines reported Phase 1 results earlier this year at the European Respiratory Society Congress in Amsterdam. Dave Singh, Professor of Clinical Pharmacology and Respiratory Medicine, University of Manchester, presented data from a study involving 96 individuals with mild to moderate asthma. Investigators found that GB-0895 was generally well tolerated across a wide dosing range, demonstrated dose-proportional pharmacokinetics with a half-life of about 89 days, and produced sustained reductions in biomarkers linked to TSLP blockade for at least six months. These findings support the twice-yearly dosing schedule under evaluation in Phase 3.

Asthma and allergy research is increasingly intersecting with advances in AI. These systems are being used to analyze clinical, visual, and environmental data to support earlier diagnosis and risk prediction. A 2025 study published in Environmental Epigenetics reports that prenatal exposure to ambient pollutants, including ozone and particulate matter, was associated with DNA methylation changes in genes relevant to asthma and allergic diseases. These findings contribute to ongoing efforts to understand why allergic conditions continue to rise as environmental pressures increase.

Clinical management of allergic diseases relies on a combination of pharmacologic treatments, immunotherapy, and avoidance of known triggers. While antihistamines, corticosteroids, and nasal sprays can mitigate symptoms, they do not modify the underlying disease process. Immunotherapy remains the only intervention capable of altering long-term disease progression, but it requires individual tailoring and long-term adherence. AI-enabled tools may help improve monitoring and adherence, especially in asthma, where guideline implementation is inconsistent.

Laurie Lee, Chief Medical Officer of Immunology and Inflammation, Generate:Biomedicines, says advancing GB-0895 into Phase 3 supports the company’s broader focus on respiratory conditions. She notes that the trials reflect a continued need for new options for people who struggle to maintain control with existing therapies.

Generate:Biomedicines, founded by Flagship Pioneering in 2018, positions its platform as a method for developing protein-based therapies through computational design. The company says its approach may provide a pathway to target diseases that have been historically difficult to address through traditional drug development methods. The US Patent and Trademark Office recently issued Patent No. 12,110,324 covering aspects of GB-0895.

If the SOLAIRIA program confirms the efficacy and safety signals observed in earlier studies, the company expects the data to support regulatory submissions in multiple regions. The trials aim to provide evidence across diverse populations as asthma prevalence continues to rise worldwide due to genetic, environmental, and behavioral factors. Research efforts also continue to examine the potential role of AI in personalizing asthma management and supporting clinical decisions, including the identification of exacerbation risks and optimization of long-term treatment strategies.