Absci reports first participants dosed in Phase 1 ABS-101 trial

Absci (ABSI) Corporation 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 randomized, double-blind, placebo-controlled, first-in-human study of single ascending doses of ABS-101 will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics 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.