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Generate Biomedicines Launches Global Phase 3 Trials for GB-0895

Generate Biomedicines has announced the initiation of two global Phase 3 clinical trials named SOLAIRIA-1 and SOLAIRIA-2. These trials aim to evaluate the efficacy of GB-0895, a long-acting anti-TSLP monoclonal antibody, in approximately 1,600 adults and adolescents suffering from severe asthma that is inadequately managed by current treatments. This innovative therapy, developed using advanced AI techniques, targets thymic stromal lymphopoietin (TSLP)—a critical factor driving airway inflammation in asthma patients.

The significance of these studies lies in being the first global Phase 3 evaluations of an anti-TSLP treatment. These trials mark a substantial advancement in the realm of programmable biology, focused on the potential of GB-0895 to provide much-needed relief for those with severe asthma. The primary objective of both studies will be to determine the drug's effectiveness in reducing clinically meaningful asthma exacerbations over a duration of 52 weeks.

The Mechanism Behind GB-0895

GB-0895 stands out as an experimental monoclonal antibody specifically designed to have a high binding affinity for TSLP and an extended half-life, allowing for biannual dosing. This long-term administration addresses the treatment burden for patients grappling with severe asthma. Moreover, GB-0895 is also being assessed in a Phase 1 study for chronic obstructive pulmonary disease (COPD), highlighting its broader potential.

Mike Nally, CEO of Generate Biomedicines, emphasized the importance of reaching this milestone, noting that it demonstrates the company's ability to rapidly design optimal molecular solutions for patients. He expressed excitement about how AI-engineered antibodies like GB-0895 can advance to critical testing phases within a short timeline, in this instance, just four years.

Dr. Laurie Lee, Chief Medical Officer focused on Immunology and Inflammation at Generate, added that despite the advancements in respiratory medicine, many individuals still struggle to control their severe asthma. The commencement of Phase 3 trials for GB-0895 reflects their commitment to supporting those living with this chronic condition and showcases the power of their innovative platform to deliver potentially transformative therapies.

Previous Findings and Presentation

Recent Phase 1 results were shared by Dave Singh, MD, a prominent figure in clinical pharmacology and respiratory medicine, at the European Respiratory Society (ERS) International Congress 2025 in Amsterdam. In this Phase 1 trial, with 96 participants having mild to moderate asthma, GB-0895 was generally well tolerated across a wide dosage range from 10 mg to 1200 mg. The pharmacokinetics indicated a proportional relationship to the dose along with an approximate half-life of 89 days. Importantly, this led to a sustained reduction in key biomarkers, demonstrating TSLP blockade lasting for at least six months, thus supporting the proposed six-month dosing regimen for the Phase 3 SOLAIRIA program.

More About the SOLAIRIA Program

The SOLAIRIA Phase 3 program for developing GB-0895 consists of the two clinical trials, SOLAIRIA-1 and SOLAIRIA-2, set to enroll around 1,600 participants across over 40 countries in North America, Europe, Latin America, and the Asia-Pacific region. Each trial will administer GB-0895 (300 mg subcutaneously every six months) versus a placebo over the course of 52 weeks, with the primary endpoint being the reduction in the annual asthma exacerbation rate. Additional assessments will encompass lung function evaluations, symptom control, and quality of life metrics. Although sharing a nearly identical design, the trials differ slightly in geographic distribution, ensuring diverse data collection from various populations. More information is available at www.solairia.com.

Innovation Behind GB-0895

GB-0895 was conceived through Generate's generative biology platform, integrating proprietary machine learning models with high-throughput experimental techniques. This drug was engineered to inhibit TSLP, which is a cytokine produced by epithelial cells that instigates and exacerbates airway inflammation in asthma. Employing a generative optimization technology suite, GB-0895 was computationally designed to enhance efficacy and prolong half-life while maintaining specificity. An animation detailing the mechanism of action can be viewed on Generate's website. US Patent No. 12,110,324 has been granted for this innovation.

About Generate Biomedicines

Generate is a technology-driven company at the intersection of machine learning, biological engineering, and medicine. Its aim is to usher in a new era of programmable biology to accelerate the development of superior therapies for patients. By combining technology with biology through its Generate platform, the company addresses previously untreatable and hard-to-treat targets alongside well-established targets in novel, efficient ways. Founded by Flagship Pioneering in 2018, Generate is clinical company leading a major shift from drug discovery to drug generation. For more information, visit www.generatebiomedicines.com or follow them on social media platforms like X, LinkedIn, and YouTube.