Shattuck Labs Announces Positive Data from the Preclinical GLP Toxicology Study of SL-325 at the 20th Congress of European Crohn's and Colitis Organization (ECCO) in Inflammatory Bowel Diseases 2025

Core Insights - Shattuck Labs, Inc. announced positive preclinical data for SL-325, a high-affinity DR3 blocking antibody aimed at treating inflammatory bowel disease (IBD) [1][2] - The company plans to file an Investigational New Drug (IND) application in the third quarter of 2025 [1][4] Preclinical Data - SL-325 demonstrated no evidence of toxicity or residual agonism in a GLP toxicology study conducted in non-human primates [1][5] - The study showed full and durable DR3 receptor occupancy at low doses, indicating potential for extended dosing intervals in humans [2][5] - No adverse effects were observed at the highest dose of 100 mg/kg, and no infusion-related reactions were noted [5][6] Mechanism and Efficacy - Inhibition of the TL1A/DR3 signaling axis by SL-325 has shown complete remission rates that match or exceed those of existing treatments like IL-23 or α4β7 blocking antibodies [2][4] - The preclinical studies suggest that targeting DR3 may provide a more comprehensive blockade compared to TL1A [2][4] Future Development - SL-325 is expected to enter Phase 1 clinical trials later in 2025, with projected dosing schedules of 1 mg/kg every two weeks for induction and 3 mg/kg every two weeks for maintenance [5][6] - The company is leveraging its expertise in protein engineering to develop SL-325 as a first-in-class treatment for autoimmune and inflammatory diseases [6]