In short
GB-0895 is an investigational protein-based medicine being studied as an add-on treatment for severe uncontrolled asthma. It is given by subcutaneous injection and is not yet authorised as a medicine.
Key points
- GB-0895 is an investigational protein-based substance with no marketing authorisation.
- It is being studied in severe uncontrolled asthma in adults and adolescents.
- The trials are Phase 3 studies comparing GB-0895 300 mg with placebo.
- One trial plans to enrol 786 participants, the other 805 participants.
- The main measure is the annualized asthma exacerbation rate over 52 weeks.
- GB-0895 is given as a subcutaneous injection.
What is GB-0895?
GB-0895 is a protein-based substance being developed as a potential medicine for severe uncontrolled asthma. It is classified in the respiratory tract diseases therapeutic area and is described in registry records as an investigational substance with no marketing authorisation. The product is supplied by Generate Biomedicines.
GB-0895 is the only name under which the substance appears in the product records. It is being tested as the study drug in the registered trials, with 0.9% sodium chloride serving as the placebo comparison.
How does GB-0895 work?
The available registry records do not describe the molecular target or mechanism of action of GB-0895. What is known is that it is a protein-based substance given by injection under the skin, and that the trials are designed to test whether adding it to existing asthma treatment can reduce the number of clinically significant asthma exacerbations.
Which conditions is it studied for?
- Severe uncontrolled asthma — a form of asthma that remains poorly controlled despite standard treatment, in which patients continue to experience exacerbations requiring systemic corticosteroids or hospital care.
How is GB-0895 given?
GB-0895 is formulated as an injection and is given by subcutaneous injection, meaning it is injected into the tissue just under the skin. The trials use a 300 mg dose given subcutaneously.
What do the clinical trials show?
Two Phase 3 trials are registered for GB-0895 in severe uncontrolled asthma. Both are named SOLAIRIA-1 and have the status "Authorised". One trial, registered on ClinicalTrials.gov, plans to enrol 786 participants. The other, registered in the EU Clinical Trials Information System, plans to enrol 805 participants.
Both trials enrol adults and adolescents with severe uncontrolled asthma. The treatment being tested is GB-0895 300 mg given by subcutaneous injection, compared with placebo (0.9% sodium chloride).
The main outcome measure in both trials is the annualized asthma exacerbation rate (AAER) over 52 weeks. An asthma exacerbation is counted as clinically significant when it requires systemic corticosteroids — given by mouth, into a vein, or into a muscle — or when it leads to hospitalisation or an emergency department visit requiring systemic corticosteroids.
GB-0895 is described as an adjunctive therapy, meaning it is being tested as an add-on to the patient's existing asthma treatment rather than as a replacement for it.
What side effects are known?
The registry records for these trials do not list side effects for GB-0895. As an investigational substance, its safety profile is still being established through the ongoing Phase 3 studies.