GB-0895 / Generate Biomedicines - LARVOL DELTA

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1) (clinicaltrials.gov) - P3 | N=786 | Not yet recruiting | Sponsor: Generate Biomedicines

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Generate:Biomedicines to Initiate Global Phase 3 Studies of GB-0895, a Long-Acting Anti-TSLP Antibody for Severe Asthma Engineered with AI (PRNewswire) - "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."

New P3 trial • Asthma • Immunology

Phase 1 Results Presented at ERS 2025 (PRNewswire) - "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."

P1 data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD (clinicaltrials.gov) - P1 | N=156 | Active, not recruiting | Sponsor: Generate Biomedicines | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - GB-0895, a high-affinity anti-TSLP mAb, demonstrates prolonged half-life and sustained pharmacological activity supporting every 6-month dosing in asthma (ERS 2025) - "A single dose of GB-0895 drives PD biomarker suppression for at least 6 months, reflecting the broad anti-inflammatory effects of the anti-TSLP mechanism seen with tezepelumab. These results support dosing GB-0895 every 6-months for the treatment of severe asthma."

Late-breaking abstract • Asthma • Immunology • Respiratory Diseases • IL13 • IL5

A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD (clinicaltrials.gov) - P1 | N=156 | Recruiting | Sponsor: Generate Biomedicines

New P1 trial • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A long-acting high affinity anti-TSLP antibody (GB-0895) for severe asthma identified leveraging a proprietary machine learning platform (ERS 2024) - "The approved anti-TSLP antibody (tezepelumab) requires monthly administration; a longer duration treatment could improve adherence and outcomes. Conclusions GB-0895 has the potential for best-in-class dosing for patients with severe asthma. A phase 1 dose escalation trial in asthma patients is underway."

Machine learning • Asthma • Immunology • Inflammation • Respiratory Diseases