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Also known as GB-0895 (SC)
GB-0895 · 3 trials · 3 indications
The annual exacerbation rate is based on clinically significant (CS) exacerbations reported by the investigator in the electronic case (eCRF) over 52 weeks for subjects on GB-0895 as compared to placebo.
| Arm | Type | Description |
|---|---|---|
| GB-0895 | EXPERIMENTAL | GB-0895 Subcutaneous (SC) injection |
| Placebo | PLACEBO_COMPARATOR | Placebo Subcutaneous (SC) injection |
| Part A: Single Ascending Dose (SAD) (asthma participants) | EXPERIMENTAL | randomized 3:1 active:placebo |
| Part B: Multiple Ascending Dose (MAD) (asthma participants) | EXPERIMENTAL | randomized 3:1 active:placebo |
| Part C: Single Dose (COPD participants) | EXPERIMENTAL | randomized 3:1 active:placebo |
| Name | Type | Description |
|---|---|---|
| GB-0895 | DRUG | Study Drug |
| Placebo | DRUG | Placebo |
| GB-0895 (SC) | BIOLOGICAL | Single subcutaneous dose of GB-0895 |
| Placebo (SC) | DRUG | Single subcutaneous dose of placebo |
1. Adults and adolescents ≥ 12 and ≤ 80 years of age. 2. Documented diagnosis of asthma for \> 12 months. 3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with n...
GB-0895 is an investigational monoclonal antibody developed by Generate Biomedicines for respiratory disease. It is being studied as adjunctive therapy in asthma, including severe uncontrolled asthma, and has also been evaluated in adults with mild to moderate asthma or COPD. GB-0895 is administered subcutaneously, which is why it also appears as GB-0895 (SC).
GB-0895 targets TSLP, a protein target also known as thymic stromal lymphopoietin. By binding TSLP, the antibody is designed to block an upstream alarm signal in the airway inflammatory cascade. GB-0895 is a monoclonal antibody given subcutaneously and is being developed for asthma indications.
GB-0895 is being developed by Generate Biomedicines, Inc., which trades under the ticker GENB. The company is running the SOLAIRIA Phase 3 program in severe uncontrolled asthma along with an earlier Phase 1 study in mild to moderate asthma or COPD.
GB-0895 is in Phase 3 clinical development for severe uncontrolled asthma, with two global Phase 3 trials currently recruiting. An earlier Phase 1 study in adults with mild to moderate asthma or COPD is active but no longer recruiting. GB-0895 remains investigational and has not been approved for any indication.
GB-0895 is being studied in the SOLAIRIA Phase 3 program: NCT07359846 (SOLAIRIA-2) and NCT07276724 (SOLAIRIA-1), each enrolling 786 adults and adolescents with severe uncontrolled asthma across multiple countries. A Phase 1 study, NCT07116889, enrolled 156 adults with mild to moderate asthma or COPD in the United States, Germany, and the United Kingdom.
Yes. GB-0895 (SC) refers to the same monoclonal antibody as GB-0895, with SC indicating subcutaneous administration. Both names describe the TSLP-targeting antibody from Generate Biomedicines that is in Phase 3 development for severe uncontrolled asthma.