Advancing Drug Development with Human Intestinal Organoids
Drug development has traditionally depended on animal models to evaluate safety and efficacy before human trials. However, significant biological differences between species mean that promising results in animals often fail to translate to humans, contributing to a high failure rate in clinical trials. Addressing this challenge, Intero Biosystems, a Denver-based startup, is pioneering the use of human intestinal organoids—miniature, lab-grown versions of human gut tissue—as more predictive models for drug testing. These organoids aim to bridge the gap between animal studies and human biology, offering researchers and pharmaceutical companies a more relevant platform to assess how drugs and other compounds interact with human intestinal tissue.
What Sets Intero Biosystems Apart?
Spun out of the University of Michigan, Intero Biosystems emphasizes the complexity of its organoids compared to simpler gut models. According to co-founder and CTO Madeline Eiken, their organoids encompass multiple cell and tissue types found in the human intestine, rather than just replicating a single layer of cells. This multicellular architecture is vital for accurately mimicking the gut’s functions and responses, providing a more reliable indicator of how drugs may behave in humans.
“Most drugs fail clinical trials, and I think it’s pretty easy to appreciate that we are neither mice nor flat layers of cells,” Eiken remarked, highlighting the limitations of traditional models.
The startup’s flagship product, GastroScreen, consists of human intestinal organoids roughly 1 millimeter in diameter. These are shipped in batches of about 100 in a tube, ready for use by pharmaceutical, biotech, food, and chemical companies. Customers can test compounds on healthy tissue or induce disease-like conditions to observe responses, providing valuable insights into drug safety and efficacy.
Co-founder and CEO Charlie Childs described the logistics: “We’re literally shipping mini living organs in the mail to people.”
Supporting Tools and Services
Beyond the organoids themselves, Intero offers a comprehensive suite of supplies necessary for culturing and experimenting with the models. This includes nutrient mixes tailored to feed the cells and chemicals used in various assays. Additionally, Intero conducts custom studies for clients, designing experiments, performing lab tests, and delivering detailed data reports. Much of this work focuses on assessing drug safety and exploring disease mechanisms—such as evaluating whether a candidate drug could damage the gut or determining how diseased tissue responds to treatments.
Founded in 2024, Intero currently employs seven people and serves just under 10 customers. Following a $2.3 million pre-seed funding round last year, the company has generated over $400,000 in revenue between Q4 2025 and Q3 2026, indicating early market traction in a competitive landscape.
Regulatory Momentum and Industry Trends
Regulatory changes have further stimulated interest in alternatives to animal testing. In April 2025, the U.S. Food and Drug Administration (FDA) announced plans to reduce reliance on animal testing for drug development. The agency is encouraging the adoption of technologies such as organoids, organs-on-chips, and AI-driven computational models as viable alternatives.
Further advancing this effort, in March 2026 the FDA issued draft guidance on validating new approach methodologies (NAMs)—non-animal testing methods—to support regulatory submissions. While the guidance offers a framework, it does not endorse any specific method, emphasizing that the suitability of each NAM depends on its use case and the robustness of supporting data.
Eiken noted that evolving U.S. laws and regulatory openness have encouraged pharmaceutical companies to explore organoid technologies more seriously, moving from early skepticism to in-house adoption.
A Competitive Landscape
Intero is among several companies innovating in the field of human-relevant gut models. Competitors include Altis Biosystems, which develops stem cell-derived intestinal models, and InSphero, which offers patient-derived intestinal organoids for gastrointestinal toxicity testing. Other companies, like MIMETAS, pursue alternative approaches such as organ-on-chip microfluidic devices that replicate human tissue environments.
Intero distinguishes itself through the complexity and scalability of its GastroScreen model. Unlike intestinal models derived from biopsy tissue obtained via colonoscopy, GastroScreen is created from induced pluripotent stem cells (iPSCs)—adult cells reprogrammed to become almost any cell type and obtainable from a simple blood sample. This method not only facilitates scaling production but also opens the door to personalized medicine by enabling models tailored to individual patients.
Validation and Future Directions
Regarding evidence that GastroScreen can more accurately predict human drug responses than animal or simpler cell-based models, CEO Charlie Childs explained that Intero is currently in the second of a three-stage validation process. After confirming that the organoids contain key human gut tissues, the company is testing well-known drugs with documented human effects. Early results have shown expected responses to drugs that reduce intestinal inflammation and to compounds known to be harmful to the gut.
The final validation stage will directly compare GastroScreen’s results with pharmaceutical companies’ existing animal data and clinical trial outcomes. These comparative studies are underway, incorporating both established compounds and new drug candidates, further demonstrating the organoids’ predictive potential.
While Intero does not currently use artificial intelligence to build its organoids, Childs envisions leveraging the biological data generated from their models to fuel AI-driven drug discovery and development. The company plans to license these datasets to pharmaceutical and AI firms, enhancing predictive modeling capabilities.
Scaling Up and Long-Term Vision
In the short term, Intero is focused on scaling production. Presently capable of manufacturing a few thousand organoids per batch, the company aims to automate and expand this capacity to hundreds of thousands. This scale-up is essential to meet growing demand and establish organoids as a mainstream drug testing tool.
Looking further ahead, Intero envisions personalized medicine applications where patient-specific organoids could be used to test drug efficacy and safety before clinical treatment. The most ambitious goal is developing an artificial intestine, building on manufacturing expertise and patient-derived data to create functional bioengineered organs.
Intero Biosystems recently showcased its innovations at TechCrunch Disrupt 2026, competing among 20 startups for the Startup Battlefield title. The event, held October 13–15 in San Francisco, highlights cutting-edge technologies shaping the future of biomedicine.
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