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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 physician diagnosis of asthma for ≥ 2 years. 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...
GB-0895 is an investigational monoclonal antibody being developed for the treatment of asthma, including severe asthma. It is studied as an adjunctive therapy in adults and adolescents with severe uncontrolled asthma, and in adults with mild to moderate asthma or COPD.
GB-0895 targets TSLP, a protein involved in airway inflammation. By binding to TSLP, the antibody is designed to modulate inflammatory pathways implicated in asthma. It is administered subcutaneously and is being evaluated in clinical trials for respiratory conditions.
GB-0895 is being developed by Generate Biomedicines, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of GB-0895 in patients with asthma and related respiratory conditions.
GB-0895 is in Phase 1 clinical development, with an ongoing study in adults with mild to moderate asthma or COPD. Additionally, two Phase 3 trials in severe asthma are listed as recruiting, indicating the program has advanced to late-stage development.
GB-0895 is being studied in three trials: NCT07359846 (SOLAIRIA-2) and NCT07276724 (SOLAIRIA-1), both Phase 3 studies in severe uncontrolled asthma, and NCT07116889, a Phase 1 study in mild to moderate asthma or COPD. All trials are actively recruiting or ongoing.
Yes, GB-0895 is also known as GB-0895 (SC), referring to its subcutaneous route of administration. This alternative name is used in clinical contexts to specify the delivery method of the investigational antibody.