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Intero Biosystems wants drugmakers to test on mini human intestines, not animals
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Intero Biosystems, a Denver-based startup spun out of the University of Michigan, is developing lab-grown human intestinal organoids as an alternative to animal testing in drug development. The company says these miniature tissues mimic the human gut and can help researchers study how drugs and other compounds affect the body before human trials. The approach aims to supplement conventional animal models, which often fail to predict human responses.
Drug development has long relied on animal models, but species differences mean promising results in animals frequently do not translate to people. Most drug candidates still fail during development, creating demand for models that better reflect human biology. Researchers and pharmaceutical companies are increasingly seeking such tools to reduce reliance on animal testing.
Intero claims its organoids are more complex than simpler models that replicate only part of the gut. They contain multiple cell and tissue types found in the human intestine, which the company believes makes them more human-relevant for testing drugs and other compounds. Co-founder and CTO Madeline Eiken said most drugs fail clinical trials, adding that humans are neither mice nor flat layers of cells.
The startup's flagship product, GastroScreen, is a human intestinal organoid model sold to pharmaceutical, biotech, food, and chemical companies. Each organoid is about 1 millimeter across, and Intero ships roughly 100 at a time in a tube, according to co-founder and CEO Charlie Childs. Customers can use the organoids as healthy intestinal models or induce disease-like conditions to test tissue responses. Childs described the process as "literally shipping mini living organs in the mail to people."
Beyond the organoids, Intero sells supplies needed to grow and work with them, including nutrient mixes that feed cells and chemicals used in experiments. It also runs studies for customers, designing custom experiments, performing lab tests, and delivering data. Much of this work focuses on drug safety and disease research, such as exposing organoids to drug candidates to see whether they could harm the gut.
Founded in 2024, Intero now has seven employees and just under 10 customers after raising a $2.3 million pre-seed round last year. It generated more than $400,000 in revenue from the fourth quarter of last year through the third quarter of this year, the CEO noted. Regulatory changes have helped drive interest in non-animal alternatives. In April last year, the U.S. Food and Drug Administration laid out plans to reduce reliance on animal testing, promoting organoids, organs-on-chips, and AI-based computational models. In March this year, the FDA issued draft guidance on validating new approach methodologies, or NAMs, providing a framework without endorsing a specific method.
Changes in U.S. law allowing drug developers to use non-animal testing in some cases have made pharmaceutical companies more willing to explore organoids, Eiken said. Companies once hesitant are now looking to bring the technology in-house. Intero is not alone: Altis Biosystems develops stem cell-derived intestinal models, InSphero offers patient-derived intestinal organoids for gastrointestinal toxicity testing, and MIMETAS uses organ-on-chip technology. As regulatory support grows, such human-relevant models could become a larger part of preclinical testing.
