Shattuck Labs says IND for SL-325 for treatment of IBD in effect

Shattuck Labs (STTK) announced that the Company’s Investigational New Drug application submitted to the U.S. Food and Drug Administration for SL-325 for the treatment of inflammatory bowel disease is in effect. SL-325, a potentially first-in-class DR3 blocking antibody, is a fully Fc-silenced humanized immunoglobulin G monoclonal antibody, demonstrated high-affinity binding to human DR3 and potent inhibition of TL1A binding to DR3 in preclinical studies, and a favorable safety profile in non-human primate studies. Dosing of the first participant is expected this quarter, and enrollment of the Phase 1 clinical trial is expected to be completed in the second quarter of 2026. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose trial in healthy volunteers evaluating safety, tolerability, and pharmacokinetics. Data from the trial will guide the doses and schedule for potential evaluation in Phase 2 clinical trials.