Absci Doses First Participants in Phase 1 Trial of AI-Designed Antibody for IBD

Absci has announced the dosing of the first participants in a Phase 1 trial of ABS-101, an investigational antibody for inflammatory bowel disease (IBD) designed using its generative AI platform. The study marks Absci’s entry into clinical development, with ABS-101 representing the company’s first therapeutic candidate to move from in silico design to human testing.

The trial (ACTRN12625000212459p) is a randomized, placebo-controlled study involving approximately 40 healthy volunteers and will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses. Interim data are expected in the second half of 2025.

ABS-101 is engineered to bind both monomeric and trimeric forms of TL1A with high potency, reduce the risk of immunogenicity, and support quarterly subcutaneous dosing—potentially improving convenience and long-term adherence compared to first-generation anti-TL1A antibodies. Preclinical results show strong target engagement and favorable pharmacologic properties in non-human primates, including low immunogenicity signals and a prolonged dosing interval.

This trial follows the company’s broader strategy to advance a pipeline of AI-designed biologics. Among its other programs is ABS-201, targeting androgenetic alopecia, with Phase 1 trials anticipated in 2026. Both candidates were developed using Absci’s Integrated Drug Creation platform, which combines synthetic biology and AI to design and optimize novel therapeutics.

Absci’s platform combines generative AI with proprietary synthetic biology tools to create and refine antibody candidates. The company’s SoluPro system is used to generate billions of protein-expressing cells, while its ACE Assay reportedly enables screening of millions of antibody variants with over 4,000-fold greater throughput than traditional methods. These data feed into AI models trained on both proprietary and public datasets to perform de novo antibody design, targeting specific epitopes and optimizing for multiple parameters such as potency, half-life, and manufacturability. 

A validation cycle in the wet lab allows for rapid iteration, with the full loop—from design to tested candidates—claimed to take as little as six weeks.

Topics: Clinical Trials