Shattuck Labs (NASDAQ: STTK) has achieved a significant milestone in its inflammatory bowel disease (IBD) program with positive preclinical data from its IND-enabling GLP toxicology study of SL-325 in non-human primates. The results demonstrate a robust safety profile and promising pharmacological characteristics that support advancement to clinical trials.
The toxicology study revealed that SL-325, a DR3 blocking antibody, maintained safety at doses up to 100 mg/kg, which was established as the no-observed-adverse effect level (NOAEL). Notably, the study showed no evidence of infusion-related reactions across all treatment groups, a critical safety consideration for biological therapeutics.
Comprehensive Safety Profile
Detailed analysis of clinical pathology parameters revealed no significant SL-325-related variations across all study groups. The comprehensive evaluation, including gross pathology and histopathology analyses, further confirmed the compound's favorable safety profile, with no concerning findings reported.
Strong Pharmacological Response
The study demonstrated full and durable DR3 receptor occupancy (RO) in peripheral blood lymphocytes across all three tested doses. This consistent pharmacological response, coupled with the compound's pharmacokinetic (PK) profile, suggests the potential for extended dosing intervals in future clinical applications.
Development Timeline and Next Steps
The successful completion of the GLP toxicology study represents a crucial step toward clinical development. Shattuck Labs has announced plans to file an Investigational New Drug (IND) application in the third quarter, with Phase 1 clinical trials to follow.
The study results indicate that SL-325 functions as a high-affinity DR3 blocking antibody without evidence of toxicity or residual agonism in cynomolgus macaques. These characteristics, combined with the favorable RO/PK profile, position SL-325 as a promising therapeutic candidate for inflammatory bowel disease treatment.
