Shattuck Labs Announces Positive Preclinical Data for SL-325 in Inflammatory Bowel Disease
Shattuck Labs, a leading biotechnology company, recently announced promising preclinical results from an IND-enabling GLP toxicology study of SL-325 in non-human primates (NHP). This breakthrough was showcased in a digital oral presentation at the 20th Congress of ECCO in Inflammatory Bowel Diseases 2025 in Berlin, Germany.
SL-325: A Potential Game Changer for Inflammatory Bowel Disease
SL-325 is a high-affinity DR3 blocking antibody under development by Shattuck Labs for the treatment of inflammatory bowel disease (IBD). IBD is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the colon and small intestine, leading to symptoms such as abdominal pain, diarrhea, and weight loss.
Preclinical Study Results: No Toxicity or Residual Agonism Observed
The preclinical study conducted on NHPs demonstrated that SL-325 exhibited no evidence of toxicity or residual agonism. This is a significant finding as it indicates that SL-325 may have a favorable safety profile and minimal risk of unwanted side effects. The absence of residual agonism is particularly important, as it suggests that SL-325 does not stimulate the immune response, which is a common concern with some other TNF-targeting therapies.
RO and PK Profile Suggestive of Extended Dosing Intervals
The receptor occupancy (RO) and pharmacokinetic (PK) profile of SL-325 observed in the study suggest extended dosing intervals. This means that SL-325 may need to be administered less frequently than some currently available TNF-targeting therapies, potentially improving patient convenience and reducing the overall treatment cost. Additionally, extended dosing intervals may also minimize the risk of developing antibodies against SL-325, which could reduce the effectiveness of the treatment.
What Does This Mean for Patients and the World?
For patients with IBD, the development of SL-325 represents a potential new treatment option with a favorable safety profile and the potential for less frequent administration. This could lead to improved patient outcomes, reduced side effects, and a better quality of life. For the world, the successful development and approval of SL-325 could mean a significant advancement in the treatment of IBD, potentially benefiting millions of people worldwide.
IND Filing Expected in Q3 2025
Shattuck Labs plans to file an Investigational New Drug (IND) application for SL-325 in the third quarter of 2025. If approved, clinical trials will begin, bringing us one step closer to making this potential game-changing treatment available to patients with IBD.
Conclusion
The positive preclinical data from Shattuck Labs’ GLP toxicology study of SL-325 in non-human primates represents a significant step forward in the development of a potential new treatment for inflammatory bowel disease. With no evidence of toxicity or residual agonism observed, and a receptor occupancy and pharmacokinetic profile suggestive of extended dosing intervals, SL-325 holds great promise for improving patient outcomes and reducing the burden of IBD. The IND filing is expected in Q3 2025, and we look forward to the next phase of clinical trials and the potential availability of this innovative treatment for patients.
- SL-325 is a high-affinity DR3 blocking antibody being developed for IBD treatment
- Preclinical study in NHPs shows no toxicity or residual agonism
- RO and PK profile suggest extended dosing intervals
- IND filing expected in Q3 2025
- SL-325 has the potential to improve patient outcomes and reduce treatment burden for IBD
