Shattuck Labs announced that its Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA) for SL-325, for the treatment of inflammatory bowel disease, is now in effect. This regulatory clearance allows the company to proceed with human clinical trials.
SL-325 is a potentially first-in-class DR3 blocking antibody, which has demonstrated high-affinity binding to human DR3 and potent inhibition of TL1A binding in preclinical studies. It also showed a favorable safety profile in non-human primate studies.
The company expects to dose the first participant in its Phase 1 clinical trial in healthy volunteers during the third quarter of 2025. Enrollment for this randomized, double-blind, placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) trial is anticipated to be completed in the second quarter of 2026.
With the IND in effect and the anticipated aggregate proceeds of up to $103 million from the recent private placement, Shattuck Labs expects to fund its operations into 2029. This financial stability supports the advancement of SL-325 through its initial clinical development.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.