Shattuck Labs announced positive preclinical data from a toxicology study of SL-325, a high-affinity DR3 blocking antibody being developed for inflammatory bowel disease (IBD). The study, conducted in non-human primates, showed no evidence of toxicity or residual agonism, even at high doses, and indicated potential for extended dosing intervals in humans. An Investigational New Drug (IND) application is expected in the third quarter of 2025.
This positive preclinical data is crucial for advancing a potential first-in-class DR3 blocking antibody for IBD. Current IBD treatments targeting TL1A, the ligand for DR3, may be less effective due to DR3’s greater abundance and constitutive expression in IBD patients. Successful development of SL-325 could offer a more complete blockade of the DR3/TL1A pathway and potentially improved outcomes for IBD patients. This progress also reinforces the importance of targeting the DR3/TL1A axis in IBD treatment.
The non-human primate study demonstrated safety, favorable pharmacokinetics, and full, durable DR3 receptor occupancy at various doses. Notably, there were no adverse effects observed, even at the highest dose tested. The data suggests the possibility of extended dosing intervals (every 2-8 weeks) in human trials, a significant factor for patient convenience and adherence. Shattuck expects to file an IND application in Q3 2025 and initiate Phase 1 clinical trials soon after.
These findings pave the way for clinical development of SL-325 and represent a potential turning point for IBD treatment. The anticipated Phase 1 trial will be essential for confirming safety and efficacy in humans and determining optimal dosing regimens. Positive results could position SL-325 as a leading candidate in the next generation of IBD therapeutics, offering a novel approach to treating this chronic inflammatory condition.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
