Generate Biomedicines, Inc.

Generate Biomedicines' GB-0895 Shows Durable 6-Month Biomarker Suppression in Phase 1, Supporting 6-Month SC Dosing in Severe Asthma

- GB-0895, an investigational anti-TSLP monoclonal antibody (proposed INN golukibart), demonstrated durable reductions in BEC, FeNO, IL-5 and IL-13 for at least six months after a single subcutaneous dose. - Phase 1 data showed dose-proportional pharmacokinetics with an approximately 98-day half-life at 300 mg and no impact from anti-drug antibodies, supporting a 6-month subcutaneous dosing regimen. - GB-0895 was well-tolerated across asthma and COPD cohorts, with most treatment-emergent adverse events mild-to-moderate and no treatment-related serious adverse events reported. - Two ongoing global Phase 3 studies (SOLAIRIA-1 and SOLAIRIA-2) are enrolling patients with severe uncontrolled asthma to evaluate annualized asthma exacerbation rate and other clinical endpoints.