11:12 AM EDT, 08/21/2025 (MT Newswires) -- Shattuck Labs ( STTK ) said Thursday its Investigational New Drug application submitted to the US Food and Drug Administration for SL-325, a blocking antibody to treat inflammatory bowel disease, is in effect.

SL-325 showed a favorable safety profile in non-human primate studies.

Dosing of healthy volunteers in the company's randomized, double-blind, placebo-controlled phase 1 trial is expected to begin in Q3, with enrollment targeted for completion in Q2 2026.

An IND being in effect means the FDA has completed its initial safety review and did not place the filing on hold, which allows the company to begin testing the drug in humans. It is an authorization to start clinical trials rather than an approval of the treatment itself.

Shattuck said its current cash and equivalents, along with up to $103 million in anticipated proceeds from a recent private placement, are expected to fund operations into 2029.

Shares of the company were down 9% in recent trading.

Price: 0.92, Change: -0.09, Percent Change: -9.01