Generate:Biomedicines just moved one step closer to reshaping respiratory medicine.
The company is launching SOLAIRIA-1 and SOLAIRIA-2, two global Phase 3 trials for GB-0895, an AI-engineered, long-acting antibody designed for severe asthma.
These studies represent the world’s first Phase 3 trials for a long-acting anti-TSLP antibody. A big moment for programmable biology.
Why GB-0895 Matters?
GB-0895 targets TSLP, a key cytokine driving airway inflammation.
It’s designed to deliver:
- Very high-affinity TSLP binding
- A long half-life
- High specificity
- Six-month dosing, reducing treatment burden
The goal is simple: fewer exacerbations, fewer hospital visits, more control for people with severe asthma.
Inside the SOLAIRIA Trials
Generate will evaluate GB-0895 in ~1,600 patients across 40+ countries. Both trials share the same core design:
- 300 mg GB-0895 subcutaneously every six months
- Compared against placebo
- 52-week duration
- Primary endpoint: reduction in annualized asthma exacerbations
- Additional measures include lung function, symptoms, and quality of life
The two trials are nearly identical, with minor geographic differences to strengthen global data.
What Phase 1 Already Showed?
Phase 1 results were presented at ERS 2025 in Amsterdam. Key insights:
- GB-0895 was well tolerated in 96 people with mild to moderate asthma.
- Half-life: ~89 days
- Dose-proportional pharmacokinetics
- Sustained biomarker reductions for at least six months
These data support the long-acting, twice-yearly dosing strategy now entering Phase 3.
What Generate Says About the Milestone?
“Advancing GB-0895 to Phase 3 is a significant milestone,”
— Mike Nally, CEO, Generate:Biomedicines
He highlights how programmable biology helped the company design this antibody with speed and precision.
“Severe asthma remains difficult to control for many people,”
— Dr. Laurie Lee, CMO, Generate
She underscores the need for therapies that reduce the burden of chronic respiratory disease.
The Bigger Picture: Why This Matters
Severe asthma still leaves many patients struggling, even with modern therapies.
A safe, long-acting TSLP blocker could:
- Reduce the fatigue of frequent dosing
- Improve adherence
- Lower exacerbation risk
- Deliver more consistent disease control
If successful, GB-0895 could set a new standard in biologics for respiratory disease.
About GB-0895 and the Platform Behind It
GB-0895 was created using Generate’s generative biology platform, which pairs machine learning with high-throughput experimentation.
The platform optimizes:
- Potency
- Half-life
- Selectivity
- Developability
This approach cuts years from traditional discovery timelines.
About Generate:Biomedicines
Generate sits at the intersection of machine learning, bioengineering, and medicine.
Founded by Flagship Pioneering in 2018, the company is building a diverse portfolio across multiple therapeutic areas using programmable biology.
