An asthma drug its maker says AI designed is in two final-stage trials of 786 patients each
Trials of a twice-yearly asthma injection began in late 2025 and early 2026. Results are due in 2028 and 2029; nothing is approved yet.
Most molecules described as AI-designed are still in early trials. GB-0895, an antibody from the Massachusetts company Generate:Biomedicines, is one of the few to reach Phase 3, the large final stage before a company can ask a regulator for approval.
The registry records two trials. SOLAIRIA-1 started on 3 December 2025 with 786 patients planned and results due December 2028. SOLAIRIA-2 started on 20 January 2026, also with 786 patients, finishing January 2029. Both take adults and teenagers whose severe asthma is not controlled by their current treatment, compare the drug against a placebo over 52 weeks, and count how many asthma attacks patients have in a year. The dose is one injection under the skin every six months.
The company says it used machine-learning models, plus a lot of lab testing, to design an antibody that grips its target harder and lasts longer in the body. The target, a signalling protein called TSLP, is not new. Generate:Biomedicines calls GB-0895 the first long-acting antibody against it to reach Phase 3, which implies shorter-acting ones already exist. In an earlier safety study of 96 people with milder asthma, reported by the company at a conference in 2025, the drug stayed in the body for about 89 days on average, which is why twice-yearly dosing looks possible.
What it means
An AI-designed medicine is being tested the same way any other new medicine is, with no shortcut: these two trials will not report until 2028 at the earliest, and only then will anyone know whether it reduces asthma attacks. For patients with severe asthma, the appeal is two injections a year instead of more frequent ones. Reaching Phase 3 says the drug has cleared safety checks, not that it works.
Caveats
- There are no results yet on whether it helps people with severe asthma. The earlier study measured safety and drug levels in a different, milder group.
- “Engineered with AI” is the company’s own description. There is no independent account of what the models did and what human chemists and biologists did.
- The early-trial numbers and the design claims come from company materials, not a peer-reviewed paper.
- Both trials read out in 2028 and 2029 at the earliest, and registry dates often slip.
- Base rates still apply. A 2024 analysis found AI-discovered molecules passed Phase 1 about 80 to 90% of the time but Phase 2 only about 40%, in line with the industry’s long-run average.