Generate:Biomedicines Advances GB-0895 Into Phase 3 — A New Benchmark in AI-Designed Asthma Therapies

Generate:Biomedicines Advances GB-0895 Into Phase 3 — A New Benchmark in AI-Designed Asthma Therapies

By, Admin 2 December 2025

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.

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