AI Promised Faster Drug Discovery. Now It Has to Prove It

Generate:Biomedicines is advancing an AI-designed asthma drug into two global Phase 3 trials, marking one of the first large-scale clinical tests of generative biology. The Somerville, Massachusetts company said it will begin the SOLAIRIA-1 and SOLAIRIA-2 studies of GB-0895, a long-acting monoclonal antibody targeting thymic stromal lymphopoietin, in roughly 1,600 patients with severe asthma who are not adequately controlled on standard treatments. It is the company’s most advanced program and the first AI-generated biologic to reach this stage with a global, year-long dataset.

Generate, founded by Flagship Pioneering in 2018, describes itself as operating at the intersection of machine learning, biological engineering, and medicine. The company says its platform uses models trained on millions of proteins to learn the rules that encode biological function, then generates new proteins with therapeutic properties. It refers to this approach as “Generative Biology.” GB-0895 is among the first molecules built fully within this framework to reach late-stage development.

The company has raised nearly $700 million in equity financing across its 2021 Series B and 2023 Series C rounds. It entered a multi-target collaboration with Novartis in 2024 that included $65 million upfront and the potential for more than $1 billion in milestones and royalties. With GB-0895 now advancing to Phase 3, the company is moving from platform claims to validation in a clinically regulated environment.

A Late-Stage Test for AI Drug Development

AI has been used in the pharmaceutical industry for more than a decade, but most activity has remained early-stage: target identification, molecular screening, or small Phase 1 studies. Published reviews point to advantages including faster molecular design cycles, improved prediction of binding affinity, and early modeling of toxicity and pharmacokinetics. Yet few AI-generated biologics have entered large, multi-country trials where efficacy must be demonstrated over a year or longer.