GenerateBiomedicines Launches Phase 3 Trials for AI-Engineered Antibody Against Severe Asthma
GenerateBiomedicines has announced the start of two pivotal Phase 3 clinical trials, named SOLAIRIA-1 and SOLAIRIA-2, aimed at assessing the efficacy of GB-0895. This innovative long-acting monoclonal antibody targets thymic stromal lymphopoietin (TSLP), a key player in airway inflammation, specifically in patients suffering from severe asthma that remains uncontrolled despite existing therapies. About 1,600 adults and adolescents from various geographic locations, including North America, Europe, Latin America, and the Asia-Pacific region, will participate in these studies over a 52-week period.
The primary objective of the trials is to evaluate how effectively GB-0895 can reduce clinically significant asthma exacerbations. Uniquely designed using artificial intelligence, GB-0895 boasts ultra-high affinity binding to TSLP, prolonging its half-life while ensuring high specificity. This medication is classified as a long-acting therapy, intended for administration every six months, allowing patients to alleviate the therapeutic burden often associated with severe asthma management. In addition, GB-0895 is currently being assessed in a Phase 1 trial for chronic obstructive pulmonary disease (COPD).
Mike Nally, CEO of GenerateBiomedicines, expressed that advancing to Phase 3 is a landmark achievement for both the company and the broader field of asthma treatment. He emphasized that this progression highlights the potential of programmable biology in developing optimal molecular solutions swiftly and precisely. Moreover, it exemplifies how an AI-designed antibody can achieve a best-in-class profile, reaching this phase of trials in just four years.
Despite remarkable advancements in respiratory medicine, managing severe asthma remains a significant challenge for many individuals. Laurie Lee, MD, an expert in immunology and inflammation at GenerateBiomedicines, stated that the commencement of these Phase 3 trials underscores their commitment to assisting those afflicted by severe asthma. It also reflects their innovative platform’s capability to facilitate the development of drugs addressing chronic respiratory diseases.
Earlier findings from the Phase 1 studies were shared at the 2025 European Respiratory Society (ERS) International Congress in Amsterdam by Dr. Dave Singh, an authority in clinical pharmacology. Data from this initial trial, which involved 96 asthma patients with mild to moderate symptoms, suggest that GB-0895 was generally well-tolerated across a dosing range from 10 mg to 1,200 mg. The findings also demonstrated a proportional pharmacokinetic relationship along with a half-life of approximately 89 days, effectively blocking TSLP for at least six months. This supports the six-month dosing regimen currently under investigation in the Phase 3 SOLAIRIA program.
The SOLAIRIA Phase 3 program comprises two global clinical trials focusing on the effectiveness of administering 300 mg of GB-0895 subcutaneously every six months compared to placebo. Outcome measures will include the annual rate of asthma exacerbations, lung function assessments, symptom control, and overall quality of life. While the designs of these trials are nearly identical, slight geographical variations ensure reliable data reflects diverse population groups.
Developed using Generate’s generative biology platform, GB-0895 is engineered to inhibit TSLP, a cytokine produced by epithelial cells that contributes to respiratory inflammation associated with asthma. The integration of proprietary machine learning models with high-throughput experimentation has allowed the computational design of GB-0895, enhancing both its potency and half-life while maintaining specificity. Learn more about this mechanism of action by visiting Generate’s website.
GenerateBiomedicines stands at the forefront of a technological shift, merging machine learning, biological engineering, and medicine to rapidly devise superior therapeutic options for patients. Its innovative platform tackles historically challenging diseases with novel and effective strategies. Established in 2018 through Flagship Pioneering, Generate continues advancing the transition from discovering new drugs to their development. For additional details, visit www.generatebiomedicines.com or follow them on social media platforms including X, LinkedIn, and YouTube.
The primary objective of the trials is to evaluate how effectively GB-0895 can reduce clinically significant asthma exacerbations. Uniquely designed using artificial intelligence, GB-0895 boasts ultra-high affinity binding to TSLP, prolonging its half-life while ensuring high specificity. This medication is classified as a long-acting therapy, intended for administration every six months, allowing patients to alleviate the therapeutic burden often associated with severe asthma management. In addition, GB-0895 is currently being assessed in a Phase 1 trial for chronic obstructive pulmonary disease (COPD).
Mike Nally, CEO of GenerateBiomedicines, expressed that advancing to Phase 3 is a landmark achievement for both the company and the broader field of asthma treatment. He emphasized that this progression highlights the potential of programmable biology in developing optimal molecular solutions swiftly and precisely. Moreover, it exemplifies how an AI-designed antibody can achieve a best-in-class profile, reaching this phase of trials in just four years.
Despite remarkable advancements in respiratory medicine, managing severe asthma remains a significant challenge for many individuals. Laurie Lee, MD, an expert in immunology and inflammation at GenerateBiomedicines, stated that the commencement of these Phase 3 trials underscores their commitment to assisting those afflicted by severe asthma. It also reflects their innovative platform’s capability to facilitate the development of drugs addressing chronic respiratory diseases.
Earlier findings from the Phase 1 studies were shared at the 2025 European Respiratory Society (ERS) International Congress in Amsterdam by Dr. Dave Singh, an authority in clinical pharmacology. Data from this initial trial, which involved 96 asthma patients with mild to moderate symptoms, suggest that GB-0895 was generally well-tolerated across a dosing range from 10 mg to 1,200 mg. The findings also demonstrated a proportional pharmacokinetic relationship along with a half-life of approximately 89 days, effectively blocking TSLP for at least six months. This supports the six-month dosing regimen currently under investigation in the Phase 3 SOLAIRIA program.
The SOLAIRIA Phase 3 program comprises two global clinical trials focusing on the effectiveness of administering 300 mg of GB-0895 subcutaneously every six months compared to placebo. Outcome measures will include the annual rate of asthma exacerbations, lung function assessments, symptom control, and overall quality of life. While the designs of these trials are nearly identical, slight geographical variations ensure reliable data reflects diverse population groups.
Developed using Generate’s generative biology platform, GB-0895 is engineered to inhibit TSLP, a cytokine produced by epithelial cells that contributes to respiratory inflammation associated with asthma. The integration of proprietary machine learning models with high-throughput experimentation has allowed the computational design of GB-0895, enhancing both its potency and half-life while maintaining specificity. Learn more about this mechanism of action by visiting Generate’s website.
GenerateBiomedicines stands at the forefront of a technological shift, merging machine learning, biological engineering, and medicine to rapidly devise superior therapeutic options for patients. Its innovative platform tackles historically challenging diseases with novel and effective strategies. Established in 2018 through Flagship Pioneering, Generate continues advancing the transition from discovering new drugs to their development. For additional details, visit www.generatebiomedicines.com or follow them on social media platforms including X, LinkedIn, and YouTube.
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