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GenerateBiomedicines Initiates Global Phase-3 Trials for GB-0895

In a significant step for asthma treatment, GenerateBiomedicines has announced the start of two global Phase-3 clinical trials, named SOLAIRIA-1 and SOLAIRIA-2. These studies aim to evaluate GB-0895, a long-acting monoclonal antibody that has been specifically engineered using artificial intelligence (AI) to combat severe asthma symptoms.

Targeting Severe Asthma

The trials will involve approximately 1,600 adult and adolescent participants whose severe asthma symptoms are inadequately controlled by existing therapies. GB-0895 targets Thymus-Stromal Lymphopoietin (TSLP), a cytokine that plays a pivotal role in airway inflammation associated with asthma. The primary goal of these studies will be to assess the effectiveness of GB-0895 in reducing clinically significant asthma exacerbations over a 52-week period.

GB-0895 represents a new approach to asthma management, being developed as a long-lasting treatment that can be administered just twice a year. This regimen aims to significantly alleviate the treatment burden for individuals suffering from severe forms of asthma.

An Innovative Approach to Drug Development

Mike Nally, the CEO of GenerateBiomedicines, emphasized the importance of this transition to Phase 3 investigations. He stated, “The progress of GB-0895 signifies a major milestone not only for our company but for the entire medical field. This innovation showcases the remarkable capabilities of programmable biology in swiftly creating optimal solutions for patients. In this case, how an AI-engineered antibody can potentially achieve exceptional effectiveness and advance to Phase 3 trials within just four years.”

Dr. Laurie Lee, Chief Medical Officer for Immunology and Inflammation at GenerateBiomedicines, added, “Despite the advancements in respiratory medicine, many patients still struggle with the challenges posed by severe asthma. The initiation of these Phase-3 studies underscores our commitment to improving the lives of people with severe asthma, alongside the strength of our platform to deliver therapies that might significantly lessen the burden of chronic respiratory diseases.”

Phase-1 Study Insights

Initial findings from a Phase-1 clinical trial for GB-0895 were presented at the 2025 European Respiratory Society (ERS) Congress held in Amsterdam. The study, which involved 96 subjects with mild to moderate asthma, demonstrated that GB-0895 was generally well-tolerated across a broad dosage range (from 10 mg to 1,200 mg). It exhibited a dose-proportional pharmacokinetics profile, achieving a half-life of approximately 89 days, and resulted in a sustained reduction of critical biomarkers associated with TSLP blockage for at least six months. These results support the proposed six-month dosing schedule currently being evaluated in the SOLAIRIA Phase-3 program.

Details of the SOLAIRIA Trials

The SOLAIRIA program encompasses two extensive clinical trials designed to evaluate GB-0895 on a global scale. Conducted in over 40 countries across North America, Europe, Latin America, and the Asia-Pacific region, the trials will administer 300 mg of GB-0895 subcutaneously every six months. The primary endpoint is the reduction in the annualized rate of asthma exacerbations, while secondary assessments will include lung function, symptom control, and quality of life.

Both studies share nearly identical designs but differ slightly in their geographical distributions, ensuring they yield robust data across various populations. Further details are accessible at www.solairia.com.

The Development of GB-0895

GB-0895 has been formulated using Generate’s generative biology platform, which effectively merges proprietary machine learning models with high-throughput experimentation. This innovative design focuses on inhibiting TSLP, a key player in asthma-related airway inflammation. Generative optimization technologies enhanced GB-0895's pharmacological profile, maintaining both its effectiveness and specificity. An animated overview of its mechanism can be viewed on the company’s website.

As part of a broader initiative, GenerateBiomedicines is dedicated to propelling advancements at the intersection of technology and biology, creating therapies that traditionally posed challenges in treatment. Founded in 2018 by Flagship Pioneering, Generate aims to revolutionize drug discovery into drug generation and is now positioned as a clinical-stage company paving the way for better patient outcomes.

For more insights, visit www.generatebiomedicines.com or follow the company on X, LinkedIn, and YouTube.