Shattuck Labs reports positive preclinical SL-325 data

AUSTIN, TX & DURHAM, NC - Shattuck Labs, Inc. (NASDAQ: STTK), a biotechnology firm focused on developing therapies for inflammatory and immune-related diseases, has announced encouraging preclinical results for its drug candidate SL-325, intended for the treatment of inflammatory bowel disease (IBD). The findings were presented during the 20th Congress of ECCO in Inflammatory Bowel Diseases 2025 in Berlin, Germany.

The preclinical study, which supported the upcoming Phase 1 clinical trials, involved non-human primates and evaluated the safety, pharmacokinetics (PK), pharmacodynamics, and immunogenicity of SL-325 over a four-week dosing period followed by a four-week recovery period. The study reported no evidence of toxicity or organ dysfunction at any dose level, with the highest no-observed-adverse-effect level at 100 mg/kg. Additionally, no infusion-related reactions or significant variations in clinical pathology parameters were observed.

Full and durable DR3 receptor occupancy was achieved at low doses, and population PK modeling suggests that extended dosing intervals may be possible in humans. The projected dose and schedule for human subjects are 1 mg/kg every two weeks (Q2W) for induction through every four weeks (Q4W) for maintenance, and 3 mg/kg Q2W for induction through every eight weeks (Q8W) for maintenance.

SL-325 is a high-affinity DR3 blocking antibody designed to provide a complete and durable blockade of the DR3/TL1A pathway, which has been clinically validated. The preclinical data suggest that DR3 blockade might be more effective than TL1A blockade due to the greater abundance of DR3 in IBD patients.

Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck, expressed optimism for SL-325’s potential, highlighting the absence of DR3 agonism at any dose level and the likelihood of extended dosing intervals in humans. Shattuck anticipates filing an Investigational New Drug (IND) application in the third quarter of 2025.

Shattuck Labs specializes in the development of novel TNF receptor agonist and antagonist therapeutics. The company’s lead program, SL-325, aims to target the DR3/TL1A pathway for the treatment of IBD and other inflammatory autoimmune diseases. While the stock has experienced significant volatility with a beta of 1.71, InvestingPro analysis suggests the company is currently undervalued, with impressive revenue growth of 382.75% over the last twelve months. For deeper insights into Shattuck’s financial health and growth potential, including 13 additional ProTips, visit InvestingPro.

The information in this article is based on a press release statement from Shattuck Labs, Inc.

In other recent news, Shattuck Labs announced progress in its DR3 blocking antibody program, SL-325, with key milestones set for 2025. The company plans to initiate a Phase 1 clinical trial for SL-325 later in the year, following the release of data from a GLP toxicology study in non-human primates in the first quarter. An Investigational New Drug (IND) filing and the start of the clinical trial are anticipated in the third quarter. Financially, Shattuck reported $90.1 million in cash and cash equivalents as of September 30, 2024, which is expected to sustain operations into 2027. The company has also been active in scientific communities, with presentations scheduled at the European Crohn’s and Colitis Organization Congress and the J.P. Morgan Healthcare Conference. Shattuck’s preclinical studies indicate promising results for SL-325, designed to block the TL1A/DR3 pathway more effectively than existing treatments. These developments position the company for significant advancements in its therapeutic efforts for autoimmune and inflammatory diseases.

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