Absci Corporation (NASDAQ: ABSI) has dosed the first healthy volunteers in a Phase 1 clinical trial evaluating ABS-101, an investigational anti-TL1A antibody for inflammatory bowel disease (IBD). This milestone marks Absci's transition to a clinical-stage biopharmaceutical company and represents the first AI-designed biologic for IBD to enter clinical trials.
The randomized, double-blind, placebo-controlled study (ACTRN12625000212459p) will evaluate single ascending doses of ABS-101 in approximately 40 healthy adult participants. The primary endpoint is safety and tolerability, with pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity serving as secondary endpoints.
"We are excited to advance ABS-101 into Phase 1 clinical trials," said Andreas Busch, PhD, Absci Chief Innovation Officer. "Designed and optimized using our generative AI platform, ABS-101 exhibits high affinity and potency, expected low immunogenicity, and an extended dosing interval—all of which are intentional attributes achieved through AI."
Potential Advantages Over First-Generation Anti-TL1A Therapies
ABS-101 was engineered using Absci's generative AI platform to deliver several potential advantages over existing anti-TL1A therapies. The drug candidate demonstrates:
- High affinity and potency against both monomeric and trimeric forms of TL1A
- Potential for quarterly subcutaneous dosing, improving patient convenience and adherence
- Anticipated low immunogenicity risk
- High bioavailability in non-human primates
Preclinical data suggests ABS-101 shows reduced internalization of TL1A immune-complexes in in vitro THP-1 immunogenicity tests compared to competitor molecules, potentially lowering the risk of anti-drug antibodies (ADAs) in clinical settings. The candidate was well-tolerated at all doses in a 13-week GLP study in cynomolgus monkeys.
The Role of TL1A in Inflammatory Bowel Disease
TL1A (TNF-like ligand 1A) is a validated target for IBD treatment. It plays a key role in promoting intestinal inflammation by activating T cells and other immune cells. By blocking TL1A, ABS-101 aims to reduce inflammation in the gastrointestinal tract of patients with conditions like Crohn's disease and ulcerative colitis.
The current IBD treatment landscape includes biologics targeting various inflammatory pathways, but many patients still experience inadequate response or loss of response over time. Anti-TL1A therapies represent a promising new approach, with several candidates in clinical development.
AI-Driven Drug Development
Sean McClain, Founder and CEO of Absci, emphasized the significance of this milestone: "The initiation of our first clinical trial marks Absci's transition to a clinical-stage biotech, with a pipeline wholly designed and optimized using AI. ABS-101 is the first proof point of our generative AI platform—a therapeutic engineered with speed and precision using AI."
Absci's Integrated Drug Creation™ platform combines AI models with a synthetic biology data engine in a continuous feedback loop. This approach enables rapid design and refinement of therapeutic candidates, potentially accelerating the traditionally lengthy drug development process.
Expanding Pipeline of AI-Designed Biologics
Beyond ABS-101, Absci is advancing additional AI-designed biologics, including ABS-201, an anti-prolactin receptor antibody for androgenetic alopecia (male and female pattern hair loss). Preclinical data for ABS-201 shows improved hair regrowth compared to existing treatments, with Phase 1 trials expected to begin in early 2026.
The company anticipates reporting interim Phase 1 data for ABS-101 in the second half of 2025, which will provide important insights into the safety profile and potential efficacy of this novel therapeutic approach.
Headquartered in Vancouver, Washington, with additional facilities in New York City and Switzerland, Absci continues to leverage its AI platform both for internal drug development and through collaborations with pharmaceutical, biotech, and academic partners.
