Shattuck Labs reports Phase 1 data for SL-325, sets Phase 2b start for Q3 2026
The company said Phase 1 results support advancing SL-325 into a Crohn's disease Phase 2b trial while it also unveiled a second DR3-targeting candidate, SL-846.
Shattuck Labs reported second quarter 2026 results on August 11, 2026, along with pipeline updates for its DR3 blocking antibody programs.
The company said Phase 1 clinical trial results for SL-325 demonstrated a potentially best-in-mechanism profile, including an immunogenicity rate of only 3.7% of participants developing antidrug antibodies, blockade of TL1A binding to DR3 lasting more than 3 months at doses of 1 mg/kg and higher, a favorable safety profile consistent with the TL1A inhibitor class, and no evidence of DR3 agonism.1
Based on those results, Shattuck said its Phase 2b trial, called RECEPTIVE-CD1, in patients with moderately-to-severely active Crohn's disease is expected to begin in the third quarter of 2026 as a randomized, double-blind, placebo-controlled study comparing three dose levels of SL-325 with placebo in about 232 patients, with a primary endpoint of endoscopic response at 12 weeks and data expected in the first half of 2028.1 The trial design also calls for patients to continue treatment through a 50-week maintenance phase under a treat-through design intended to evaluate accumulating efficacy, with eligibility for a long-term extension.1
Shattuck also disclosed its bispecific candidate SL-846, described as a potentially first-in-class, half-life extended DR3 x IL-23 receptor blocking antibody for inflammatory and immune-mediated diseases.1 The molecule is in an ongoing IND-enabling GLP toxicology study in non-human primates.1 The company said it plans to present preclinical safety, pharmacokinetic and receptor occupancy data from that study at UEG Week, October 17-20, 2026, and expects to start a Phase 1 healthy volunteer trial with initial data reported in 2027.1
On financing, Shattuck said cash, equivalents and short-term investments totaled $208.3 million as of June 30, 2026, and that this is expected to fund operations into 2029, based on current operational plans and excluding any additional capital, business development proceeds, or added clinical costs.1
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