Shattuck Labs SL-325 IND现已生效;临床前数据显示DR 3高亲和力结合和良好的安全性特征

– SL-325 is a potentially first-in-class DR3 antagonist antibody being developed for the treatment of Inflammatory Bowel Disease (IBD) and other inflammatory and immune-mediated diseases –

– The Company is on track to dose the first participant in its Phase 1 SL-325 clinical trial in healthy volunteers in Q3 2025 –

– Current cash and cash equivalents, plus the anticipated aggregate proceeds of up to $103 million from recent private placement, assuming full exercise of common stock warrants, expected to fund operations into 2029 –

AUSTIN, TX and DURHAM, NC, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ:STTK), a biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with inflammatory and immune-mediated diseases, today announced that the Company's Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA) 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 (SAD) and multiple-ascending dose (MAD) 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.