Generate:Biomedicines releases early GB-0895 respiratory data after ERS poster leak

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 subcutaneous anti-TSLP antibody. The drug is being tested in the ongoing Phase 3 SOLAIRIA-1 and SOLAIRIA-2 trials for severe uncontrolled asthma.

The data remain early-stage and do not establish clinical efficacy or regulatory approval. The accidental release was reportedly followed by a pullback in Generate’s stock.