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Generate Biomedicines Initiates Global Phase 3 Trials for GB-0895

Generate Biomedicines has made significant strides in the fight against severe asthma with the announcement of their upcoming global Phase 3 clinical trials, designated SOLAIRIA-1 and SOLAIRIA-2. These pivotal studies will involve approximately 1,600 participants, specifically adults and adolescents experiencing inadequately controlled severe asthma despite current therapies.

GB-0895 represents an innovative approach in asthma treatment, as it is a long-acting monoclonal antibody specifically engineered to target thymic stromal lymphopoietin (TSLP)—a critical cytokine implicated in airway inflammation. The primary goal of these Trials is to evaluate the effects of GB-0895 in terms of reducing clinically significant asthma exacerbations over a 52-week period.

This investigational therapy is particularly noteworthy for its design. Thanks to advanced AI technologies, GB-0895 achieves ultra-high-affinity binding to TSLP, extended half-life, and enhanced specificity. Designed for administration every six months, GB-0895 aims to alleviate the treatment burden for individuals battling severe asthma. Additionally, this drug is being explored in a separate Phase 1 clinical trial concerning chronic obstructive pulmonary disease (COPD).

As stated by Mike Nally, CEO of GenerateBiomedicines, advancing GB-0895 into Phase 3 trials marks a significant milestone not only for the company but also for the overall medical field. He emphasized the potential of programmable biology, which allows for the rapid and intentional design of optimized molecular solutions for patients. The swift progress from concept to Phase 3 within four years underscores this potential.

Dr. Laurie Lee, Chief Medical Officer for immunology and inflammation at GenerateBiomedicines, added that while advancements in respiratory medicine have been remarkable, many individuals with severe asthma still face challenges in managing their condition. The initiation of these Phase 3 studies signifies their commitment to improving quality of life for these patients through innovative treatments.

The Phase 1 results of GB-0895 were presented at the European Respiratory Society (ERS) International Congress 2025 by Dr. Dave Singh. The study, which involved 96 subjects with mild to moderate asthma, revealed that GB-0895 was well tolerated across various doses ranging from 10 mg to 1,200 mg. Moreover, the data demonstrated dose-proportional pharmacokinetics with a remarkably long half-life of approximately 89 days, indicating sustained reductions in vital biomarkers consistent with TSLP blockade for up to six months. These findings bolster the six-month dosing regimen currently being assessed in the SOLAIRIA program.

About the SOLAIRIA Trials

The GB-0895 development program encompasses two global clinical trials, SOLAIRIA-1 and SOLAIRIA-2, which are set to recruit around 1,600 patients with severe asthma across over 40 countries, spanning North America, Europe, Latin America, and Asia Pacific. Each trial will compare GB-0895 (300 mg subcutaneously every six months) against a placebo over a year. The primary measure will be the reduction in annualized asthma exacerbation rate, supplemented with assessments related to lung function, symptom control, and quality of life.

While the two studies share similar designs, they will have slight variations in geographic distribution to ensure comprehensive data collection across diverse populations. More details on the trials can be found at www.solairia.com.

About GB-0895

GB-0895's design and optimization stem from Generate's generative biology platform, which merges proprietary machine learning models with high-throughput experimentation. The antibody was engineered to effectively inhibit TSLP, which serves as a catalyst for airway inflammation in asthma. By employing a generative optimization technology stack, GB-0895 has been computationally fine-tuned to enhance potency and extend its half-life while ensuring specificity remains intact. A visual representation of its mechanism of action is available on the Generate website. Notably, U.S. Patent No. 12,110,324 has been issued for GB-0895.

About GenerateBiomedicines

Founded in 2018 by Flagship Pioneering, GenerateBiomedicines is a groundbreaking tech company that marries machine learning with biological engineering and medicine. By revolutionizing the process of drug generation, they're able to address previously untreatable targets and innovate established treatments in more effective manners. Their comprehensive pipeline encompasses numerous therapeutic areas and protein-based modalities, with an aim to tackle health challenges that traditional methodologies have struggled to adequately address. To learn more about their mission, visit www.generatebiomedicines.com or follow them on social media platforms such as X, LinkedIn, and YouTube.