GenerateBiomedicines Launches Phase 3 Trials of GB-0895 for Severe Asthma

On December 1, 2025, GenerateBiomedicines, a forward-thinking biotechnological company, announced the initiation of two global Phase 3 clinical studies, SOLAIRIA-1 and SOLAIRIA-2, for their innovative treatment GB-0895. This long-acting monoclonal antibody is designed to target the thymic stromal lymphopoietin (TSLP) pathway, which plays a significant role in the inflammation associated with severe asthma.

The SOLAIRIA trials will involve approximately 1,600 participants, both adults and adolescents, struggling with severe asthma that remains uncontrolled by existing therapies. This marks a significant progression in the clinical evaluation of GB-0895, highlighting its potential as a groundbreaking solution in asthma treatment.

Key Features of the GB-0895 Design

GB-0895 has been meticulously optimized using artificial intelligence to achieve ultra-high affinity for TSLP, boasting a prolonged half-life which allows for biannual administration. This approach not only simplifies treatment for patients but also aims to alleviate the overall treatment burden often experienced in chronic asthma management. The main objective of the ongoing trials will be to assess the effectiveness of GB-0895 in reducing clinically significant asthma exacerbations over a span of 52 weeks.

In addition to its Phase 3 studies, GB-0895 is also undergoing evaluation in a Phase 1 trial aimed at patients with chronic obstructive pulmonary disease (COPD), underscoring the versatility of this treatment option.

Expert Commentary

Mike Nally, CEO of GenerateBiomedicines, expressed, “Advancing GB-0895 into Phase 3 is a monumental achievement for Generate and the industry overall. It embodies the potential of programmable biology in fast-tracking optimal molecular solutions for patients.”

Dr. Laurie Lee, Chief Medical Officer of Immunology and Inflammation at Generate, added, “Severe asthma remains a challenging condition for many, despite notable advancements in respiratory medicine. The initiation of our Phase 3 trials for GB-0895 represents our commitment to providing relief for those living with severe asthma.”

Previous Trials and Future Aspirations

The initial findings from the Phase 1 trials of GB-0895 were recently presented at the European Respiratory Society's congress in Amsterdam. During these initial studies involving 96 participants, GB-0895 proved to be well tolerated across a wide dosage range, from 10 mg to 1200 mg. The results demonstrated a proportional pharmacokinetic profile, with an average half-life of approximately 89 days, coupled with significant reductions in key biomarkers consistent with TSLP blockade lasting for at least six months. This data supports the regimen being tested in the SOLAIRIA trials, which is expected to resonate positively in diverse populations across over 40 countries, where these studies are set to unfold.

About GenerateBiomedicines

Founded to revolutionize drug discovery, GenerateBiomedicines integrates machine learning with biological engineering to pioneer a new era of programmable biology aimed at designing superior medical therapies swiftly. Since its inception in 2018 by Flagship Pioneering, it has focused on addressing traditionally complex health issues using innovative approaches that promise effective solutions.

The company's shared vision seeks to redefine the trajectory of drug discovery towards a future where customized treatments are feasible, reflecting their commitment to improving global health. Those interested in the clinical developments of GB-0895 can visit www.solairia.com for further information.

For media inquiries, contact:
Megan McLaughlin
Email: [email protected]

This announcement signals an exciting chapter for GenerateBiomedicines and the field of severe asthma treatment. As they progress with the SOLAIRIA studies, the medical community and patients alike will be keenly observing the outcomes that could redefine approaches to asthma management.