Generate: Biomedicines disclosed early clinical data for GB-0895 after draft posters were accidentally posted on the European Respiratory Society (ERS) website on August 25, ahead of the expected September 7 embargo. The company filed an SEC Form 8-K and furnished final versions of three posters covering asthma Phase 1 data, COPD Phase 1b data, and the design of the SOLAIRIA-1 and SOLAIRIA-2 Phase 3 asthma trials. In a 96-person asthma study, GB-0895 was generally well tolerated, with no treatment-related serious adverse events. The 300 mg dose produced maximal suppression of blood eosinophils, FeNO, IL-5 and IL-13 for at least six months, with an estimated half-life of about 98 days. In the 40-person COPD study, single doses of 300 mg or 600 mg produced rapid, sustained reductions in the same inflammatory biomarkers for at least six months. No treatment-related serious adverse events were reported. The findings support Generate’s goal of developing GB-0895 as a twice-yearly s...
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