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SOLAIRIA-1 and SOLAIRIA-2 will evaluate GB-0895 in approximately 1,600 patients with severe asthma whose disease remains inadequately controlled on current therapies
These are the first global Phase 3 studies of a long-acting anti-TSLP antibody, marking a pivotal step as GB-0895 advances the promise of programmable biology
SOMERVILLE, Mass., Dec. 1, 2025 /PRNewswire/ -- Generate:Biomedicines (\"Generate\") today announced it plans to initiate two global Phase 3 clinical trials, SOLAIRIA-1 and SOLAIRIA-2, evaluating GB-0895 in approximately 1,600 adults and adolescents with severe asthma whose disease remains inadequately managed on current therapies. GB-0895 is an investigational, long-acting monoclonal antibody engineered with AI to target thymic stromal lymphopoietin (TSLP), a key driver of airway inflammation. These studies will evaluate the efficacy of GB-0895 in reducing clinically significant asthma exacerbations over 52 weeks, the primary objective for both trials.
GB-0895 is an antibody optimized using AI to achieve ultra-high-affinity TSLP binding, extended half-life, and high specificity. It is being developed as a long-acting therapy designed for dosing every six months to help reduce the treatment burden for people with severe asthma. GB-0895 is also being evaluated in a Phase 1 clinical trial in chronic obstructive pulmonary disease (COPD).
"Advancing GB-0895 into Phase 3 marks an important milestone for Generate and for the field," said Mike Nally, chief executive officer of Generate:Biomedicines. "It demonstrates the potential of programmable biology to design optimal molecular solutions for patients with unprecedented speed and intentionality — in this instance, showing how an antibody engineered with AI can achieve a potentially best-in-class profile and advance into Phase 3 studies within just four years."
"Despite significant advances in respiratory medicine, severe asthma remains difficult to control for many people," said Laurie Lee, MD, chief medical officer for immunology & inflammation at Generate:Biomedicines. "Initiating Phase 3 studies for GB-0895 reflects both our commitment to people living with severe asthma and the strength of our platform to bring forward medicines that could reduce the burden of chronic respiratory disease."
Phase 1 Results Presented at ERS 2025
Dave Singh, MD, professor of clinical pharmacology and respiratory medicine at the University of Manchester and medical director at the Medicines Evaluation Unit, presented Phase 1 data for GB-0895 at the European Respiratory Society (ERS) International Congress 2025 in Amsterdam. In this study of 96 people with mild to moderate asthma, GB-0895 was generally well tolerated across a wide dose range (10 mg to 1,200 mg), demonstrated dose-proportional pharmacokinetics with an approximately 89-day half-life, and produced sustained reductions in key biomarkers consistent with blocking TSLP for at least six months. These data support the six-month dosing schedule now being evaluated in the Phase 3 SOLAIRIA program. The full presentation from ERS is available on Generate's website.
About SOLAIRIA
The Phase 3 development program for GB-0895 includes two global clinical trials, SOLAIRIA-1 and SOLAIRIA-2, enrolling approximately 1,600 patients with severe asthma across more than 40 countries in North America, Europe, Latin America, and Asia Pacific. Each trial will evaluate GB-0895 (300 mg subcutaneous every six months) versus placebo over 52 weeks, with a primary endpoint of reduction in annualized asthma exacerbation rate and additional assessments of lung function, symptom control, and quality of life. These replicate studies share nearly identical designs but differ slightly in geographic distribution to ensure robust data across diverse populations. More information is available at www.solairia.com.
About GB-0895
GB-0895 was designed with Generate's generative biology platform, which integrates proprietary machine-learning models with high-throughput experimentation. GB-0895 was engineered to block TSLP, an epithelial cell-derived cytokine that helps initiate and amplify airway inflammation in asthma. Using a generative optimization technology stack, GB-0895 was computationally designed to improve potency and half-life while retaining specificity. A mechanism-of-action animation can be viewed on Generate's website. Patent No. 12,110,324 has been issued by the U.S. Patent and Trademark Office.
About Generate:Biomedicines
Generate is a technology company founded at the intersection of machine learning, biological engineering, and medicine that is advancing a new era of programmable biology to engineer better medicines for patients, faster. The Generate Platform's infusion of technology into biology allows us to address historically undruggable and hard-to-drug targets as well as known targets in new and more effective ways. The platform has enabled the generation of a broad pipeline of therapies across multiple therapeutic areas and protein-based modalities, addressing health challenges out of reach of traditional approaches. Founded by Flagship Pioneering in 2018, Generate is a clinical-stage company leading a fundamental shift from drug discovery to drug generation. Learn more at www.generatebiomedicines.com or follow us on X, LinkedIn, and YouTube.
Generate Media Contact
Megan McLaughlin
pr@generatebiomedicines.com
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