Press release
Absci Announces First Participants Dosed in Phase 1 Clinical Trial of ABS-101, a Potential Best-In-Class anti-TL1A Antibody for the Treatment of Inflammatory Bowel Disease
Absci becomes clinical stage company with ABS-101, first AI-designed biologic for IBD, beginning Phase 1 trial Preclinical data for ABS-101 demonstrates high
About this update from Absci Corporation
[{"type":"text","content":"Absci becomes clinical stage company with ABS-101, first AI-designed biologic for IBD, beginning Phase 1 trial Preclinical data for ABS-101 demonstrates high potency and potential for quarterly dosing, an improvement in efficacy and convenience over first-generation anti-TL1As Interim data anticipated in the second half of 2025 VANCOUVER, Wash., May 13, 2025 (GLOBE NEWSWIRE) -- Absci Corporation (NASDAQ: ABSI) a clinical-stage biopharmaceutical company advancing breakthrough therapeutics with generative AI, today announced that the first healthy volunteers have been dosed in a randomized, placebo-controlled Phase 1 study evaluating ABS-101, an investigational anti-TL1A antibody engineered with Absci’s generative AI platform. ABS-101 is formulated for quarterly subcutaneous dosing, superior potency against monomeric and trimeric TL1A, and reduced immunogenicity risk enabling improved efficacy, patient convenience, and adherence. Interim safety, PK/PD, and immunogenicity data are expected in the second half of 2025. \"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.\" The Phase 1 (ACTRN12625000212459p) randomized, double-blind, placebo-controlled, first-in-human study of single ascending doses of ABS-101 will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy volunteers. The study is expected to enroll approximately 40 healthy adult participants. The primary endpoint is safety and tolerability, with PK, PD, and immunogenicity serving as secondary endpoints. The Phase 1 interim data readout is expected in the second half of 2025. “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,” said Sean McClain, Founder and CEO of Absci. “ABS-101 is the first proof point of our generative AI platform—a therapeutic engineered with speed and precision using AI. With a growing pipeline of AI-designed biologics, we’re accelerating a new chapter to bring better biologics to patients, faster.” In addition to ABS-101, A...