Generate Biomedicines to Showcase Groundbreaking Phase 1 Results for AI-Engineered GB-0895 at European Respiratory Society Congress
Cutting-Edge Developments in Asthma Treatment
Generate Biomedicines is making headlines with its upcoming presentation at the European Respiratory Society International Congress. On September 28, 2025, the company will unveil the results from its Phase 1 clinical trial of GB-0895, a novel therapeutic designed to combat asthma.
About GB-0895
GB-0895 is an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody that has been engineered using generative AI technology. This innovative therapy is notable for its high affinity and ultra-long half-life, promising to enhance patient outcomes through sustained pharmacological benefit. In clinical settings, GB-0895 is administered via a subcutaneous injection, requiring only one dose every six months, thus significantly reducing the treatment burden on asthma patients.
The Phase 1 study evaluated the safety and efficacy of GB-0895, enrolling 96 participants with mild to moderate asthma and a baseline eosinophil count of ≥150 cells/µL. The trial had two parts: a single ascending dose (Part A) and a multiple ascending dose (Part B). Notably, the findings from Part A will be highlighted during the upcoming presentation, showcasing GB-0895’s safety across a wide dose range from 10 mg to 1200 mg.
Clinical Trial Insights
The results reveal that GB-0895 is well tolerated, exhibiting dose-proportional pharmacokinetics with a prolonged half-life of approximately 89 days. More importantly, sustained reductions in eosinophil levels and inflammatory markers such as FeNO, IL-5, and IL-13 were observed for a minimum of six months after treatment. These findings indicate the therapy's robust potential in managing asthma symptoms and suggest an effective regimen requiring only biannual dosing.
Pioneering the Future of Asthma Care
Mike Nally, CEO of Generate Biomedicines, articulated the significance of these findings: “Generative biology is moving drug discovery from a process of chance to one of design. The Phase 1 results are an important proof point on our path toward later-stage trials.” He underscored that GB-0895 was designed to alleviate the treatment burden many asthma patients encounter today.
Professor Dave Singh, a leading researcher and medical director at the Medicines Evaluation Unit, endorsed the potential impact of GB-0895 in improving existing treatment regimens for respiratory diseases. He stated, “GB-0895 could provide an important treatment alternative for severe asthma patients, adding to the established benefit-risk profile linked with the anti-TSLP mechanism of action.” His comments underscore how GB-0895 could redefine asthma management by offering the convenience of intermittent dosing instead of frequent administrations.
Upcoming Presentation Details
The session will take place from 1545 to 1700 on September 28, 2025, in Amsterdam, Netherlands. The title of the presentation is: “GB-0895, a high-affinity anti-TSLP mAb, demonstrates prolonged half-life and sustained pharmacological activity supporting every 6-month dosing in asthma.” The insights presented will mark a pivotal moment in understanding and potentially reshaping the future of asthma treatment.
Conclusion
As Generate Biomedicines supports its innovative approach with the Phase 1 trial results for GB-0895, the respiratory health community is keenly anticipating the findings. This research could herald a new era in asthma management, where therapies are not only effective but also user-friendly, allowing patients to lead healthier lives with reduced medication schedules. The conference presentation promises to elucidate these transformations in detail, promising hope for many affected by asthma worldwide.
For more details on GB-0895, visit Generate Biomedicines.
Topics Health）
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