#USA #Somerville #GB-0895 #Generate Biomedicines #asthma

Generate Biomedicines Initiates Phase 3 Trials for GB-0895

Generate Biomedicines, a pioneering company in the field of programmable medicine, has recently announced the commencement of two global Phase 3 clinical trials, named SOLAIRIA-1 and SOLAIRIA-2. These trials are set to evaluate the effectiveness of GB-0895, an experimental long-acting monoclonal antibody designed for the treatment of severe asthma. Approximately 1,600 patients suffering from asthma that is not adequately controlled by existing therapies will participate in these studies.

GB-0895 emerges as a particularly promising treatment option due to its ability to target thymic stromal lymphopoietin (TSLP), a key factor involved in respiratory inflammation. The primary objective of the SOLAIRIA trials is to demonstrate the efficacy of GB-0895 in reducing clinically significant asthma exacerbations over a span of 52 weeks.

The groundbreaking aspect of GB-0895 lies in its development using artificial intelligence, facilitating the creation of a high-affinity binding antibody with extended half-life and specificity. This innovative therapy is designed to be administered every six months, significantly minimizing the treatment burden for individuals with severe asthma.

Mike Nally, the Chief Executive Officer of GenerateBiomedicines, emphasized the significance of advancing GB-0895 to Phase 3, stating, “This marks a pivotal milestone for Generate and the industry, showcasing the potential of programmable biology in designing optimal molecular solutions for patients with unprecedented speed and intent. GB-0895 exemplifies how an AI-designed antibody can achieve a leading category profile and proceed to Phase 3 trials within just four years.”

Despite advancements in respiratory medicine, severe asthma continues to pose challenges for many individuals. Dr. Laurie Lee, the Chief Medical Officer at Generate, remarked on the initiation of these trials as a reflection of the company's commitment to those living with severe asthma and the strength of their platform to provide medications that could alleviate the burden of chronic respiratory diseases.

Phase 1 Data Review

The Phase 1 clinical trial data were recently presented at the 2025 International Congress of the European Respiratory Society (ERS) in Amsterdam. Conducted on a cohort of 96 participants with mild to moderate asthma, the results indicated that GB-0895 was well tolerated across a wide dose range (10 mg to 1,200 mg). It exhibited dose-proportional pharmacokinetics with a half-life of approximately 89 days, yielding sustained reductions in key biomarkers indicative of TSLP blockade lasting for at least six months. This reassures the proposed six-month dosing regimen currently being assessed in the Phase 3 SOLAIRIA program.

About the SOLAIRIA Trials

The Phase 3 development program for GB-0895 encompasses two global clinical trials, SOLAIRIA-1 and SOLAIRIA-2, recruiting around 1,600 patients diagnosed with severe asthma across more than 40 countries, including regions in North America, Europe, Latin America, and Asia-Pacific.

Each trial will compare GB-0895 (300 mg subcutaneously every six months) to a placebo over the course of 52 weeks, focusing on reducing the annualized exacerbation rate of asthma as the primary outcome measure. Additional assessments will include evaluations of lung function, symptom control, and quality of life for participants.

Both trials are designed with nearly identical methodologies but differ slightly in geographical distribution to ensure comprehensive data across diverse populations. Detailed information regarding the trials can be accessed at SOLAIRIA's official website.

The GB-0895 Innovation

The design of GB-0895 stems from Generate's generative biology platform, which integrates proprietary machine learning models with high-throughput experimentation. This targeted approach aims to effectively block TSLP, a critical cytokine derived from epithelial cells, which plays a substantial role in initiating and amplifying airway inflammation in asthma.

Utilizing a generative optimization technology stack, GB-0895 was developed with computational resources to enhance its potency and half-life while maintaining specificity. A video demonstration of its mechanism of action is available on Generate's website.

About GenerateBiomedicines

Founded at the intersection of machine learning, biological engineering, and medicine, Generate is a technology company propelling a new era of programmable biology to design better medicines for patients at an accelerated pace. By infusing technology into biology, the Generate platform addresses historically challenging or considered incurable targets with innovative and more effective treatments. Founded in 2018 by Flagship Pioneering, Generate operates as a clinical-stage company aiming to revolutionize drug discovery and generation. For more details, visit Generate's website or follow them on X, LinkedIn, and YouTube.