Generate Biomedicines Launches Global Phase III Trials for Antibody GB-0895 in Severe Asthma Treatment

Generate Biomedicines Initiates Phase III Trials for GB-0895

Generate Biomedicines, a biotech firm specializing in AI-driven drug discovery, has announced the commencement of two crucial global Phase III clinical trials, named SOLAIRIA-1 and SOLAIRIA-2. These trials aim to assess the effectiveness of GB-0895, a long-acting monoclonal antibody designed to target thymic stromal lymphopoietin (TSLP), a key cytokine involved in inflammatory pathways associated with severe asthma.

Overview of the Trials

The SOLAIRIA trials will include approximately 1,600 adult and adolescent participants with severe asthma, who struggle to manage their symptoms under existing treatment regimens. The primary outcome is to evaluate the capability of GB-0895 in reducing clinically significant asthma exacerbations over a span of 52 weeks. This marks the first Phase III studies for a long-acting antibody targeting TSLP.

Significance of GB-0895

GB-0895 stands out for its development through cutting-edge AI methodologies that optimize its pharmacologic properties, including an ultra high affinity for TSLP and an extended half-life, enabling biannual dosing. This design aims to alleviate the burden of chronic treatment for individuals suffering from severe asthma. The ongoing research also investigates its application in Chronic Obstructive Pulmonary Disease (COPD).

CEO Mike Nally remarked, "Advancing GB-0895 into Phase III studies is a pivotal milestone for Generate and the broader industry. It illustrates the potential of programmable biology in designing optimal molecular solutions for patients."

Dr. Laurie Lee, Chief Medical Officer for Immunology and Inflammatory Conditions at Generate, highlighted the persistent challenges of severe asthma, stating, "Despite significant advancements in respiratory medicine, uncontrolled severe asthma remains a substantial challenge for many. The initiation of Phase III studies for GB-0895 reflects our commitment to asthma patients and the strength of our technological platform."

Previous Findings and Upcoming Data Presentation

The results from the Phase I trial, which was presented by Dr. Dave Singh at the European Respiratory Society’s annual conference in 2025, indicated that GB-0895 was well-tolerated across a wide range of doses, demonstrating proportional pharmacokinetics with a half-life around 89 days. Notably, the data showed sustained reductions in significant biomarkers, correlating with effective TSLP blockade for over six months, thereby reaffirming the projected six-month dosing regimen under evaluation in Phase III.

Detailed Study Design

The SOLAIRIA development program includes the two parallel trials which assess GB-0895 (300 mg subcutaneously every six months) against a placebo over 52 weeks. The primary endpoint is the annual rate of asthma exacerbations, but the trials will also measure lung function, symptom control, and quality of life. While both studies are designed similarly, they vary in geographical distribution, aiming to provide robust data across diverse populations. More details can be found at www.solairia.com.

The Science Behind GB-0895

GB-0895 has been engineered using Generate's generative biology platform, which fuses proprietary machine learning models with high-throughput experiments. Targeting TSLP, this antibody is designed to modulate the immune response that exacerbates asthma symptoms. The design philosophy incorporates various generative optimization technologies to enhance efficacy while maintaining specificity. To see an animation explaining its mechanism of action, visit Generate's website.

About Generate Biomedicines

Founded in 2018 by Flagship Pioneering, Generate is at the forefront of a transformative shift from drug discovery to engineered manufacturing, employing machine learning, biological engineering, and medicine to develop better therapies faster. The platform allows tackling both previously unreachable molecular targets and known challenges employing novel methods, addressing health issues beyond the scope of traditional pharmacological approaches. For further information, visit www.generatebiomedicines.com or follow them on X, LinkedIn, and YouTube.