Aurora, Colorado-based Intero Biosystems Inc. has received a USD 1.05 million Small Business Innovation Research (SBIR) Phase II grant from the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health, to scale up its human intestinal organoid platform for preclinical drug testing, according to NIH Reporter. The award reflects continued federal interest in tissue models that could reduce reliance on animal testing during early drug development.
The company's stem cell-derived organoid incorporates epithelium, fibroblasts, smooth muscle, vasculature and neurons, aiming to replicate intestinal architecture more closely than standard cell monolayers or animal models, which the company says fail to predict roughly 90% of clinical drug failures. Having established toxicity and fibrosis assays in Phase I, Intero will use the new funding to standardize manufacturing, cryopreservation and quality-control benchmarks for commercial distribution, while expanding cytotoxicity screening and testing antifibrotic activity against both FDA-approved drugs such as pirfenidone and nintedanib and experimental compounds. The work targets acute, chronic and immune-mediated fibrosis models.
The grant is a competitive renewal under the SBIR/STTR mechanism, pairing company principal investigator Charlie Childs with University of Michigan organoid researcher Jason Spence. NCATS' continued support for multicellular, human-derived assays fits a broader push—reinforced by the FDA Modernization Act 2.0—toward "new approach methodologies" that regulators and drug developers are increasingly evaluating as alternatives to animal studies. Competing approaches include organ-on-chip systems and simpler epithelial-only organoid models, though Intero's platform is distinguished by its multi-lineage cellular composition. Whether the assays translate into broad commercial or regulatory uptake will depend on the validation data generated during this Phase II period, which runs through mid-2028.
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