AI-designed irritable bowel disease drug enters human trials for the first time

Absci’s generative AI-created antibody for irritable bowel disease enters clinical trials, marking a significant milestone for AI drug development. This Phase I trial represents one of the first attempts to secure regulatory approval for a therapy designed entirely using artificial intelligence, highlighting the pharmaceutical industry‘s ongoing efforts to transform the traditionally lengthy and expensive drug development process through AI-powered innovation.

The big picture: Absci has begun Phase I clinical trials for ABS-101, an antibody therapy for irritable bowel disease created from scratch using generative AI.

• The company has officially dosed the first patients in the trial, administering the drug to healthy volunteers to test for safety.
• This milestone transforms Absci into a clinical-stage biotech company and represents a landmark moment in AI-driven drug discovery.

Why this matters: No drugs developed entirely by AI have yet received regulatory approval, making each advancement toward this goal particularly significant for the pharmaceutical industry.

• Phase I is the first of three required clinical trial phases that must be completed before a drug can be considered for FDA approval.
• The primary purpose of this initial phase is to demonstrate the absence of adverse side effects when the compound enters human subjects.

By the numbers: Absci claims AI has dramatically accelerated their development timeline and reduced costs.

• The company brought ABS-101 to clinical trials in just 24 months at a cost of $15 million.
• This represents a significant improvement over traditional development methods, which typically require 5 years and $50-$100 million.

Key details: The Phase I trial follows rigorous scientific protocols to establish safety and gather preliminary data.

• The study is randomized, double-blind, and placebo-controlled, involving approximately 40 healthy adult participants.
• Researchers will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics, with interim data expected in the second half of 2025.

The technical advantage: The ABS-101 antibody targets a specific protein linked to inflammatory autoimmune diseases.

• The generative AI-designed therapy binds to the TL1A protein in immune cells, whose over-expression has been connected to inflammatory conditions.
• The company aims to address previous shortcomings in antibody therapies, including the development of anti-drug antibodies in patients.

Between the lines: Absci’s AI approach has enabled unconventional advantages even in the earliest trial phase.

• The therapy is already being administered subcutaneously, an unusual approach for Phase I trials.
• This delivery method brings the experimental therapy closer to its final, patient-friendly form earlier in the development process.