Why animal testing fails drugmakers

Most drugs fail clinical trials because differences between animal species and humans mean results don't translate. Intero Biosystems is developing a better model using lab-grown human intestinal tissue.

What makes Intero's organoids different

Intero's organoids contain multiple cell and tissue types found in the human intestine, unlike simpler models that replicate only part of the gut.Co-founder and CTO Madeline Eiken said this makes them more human-relevant for testing.

The core problem Intero solves

Most drugs fail clinical trials, and Madeline Eiken, co-founder and CTO, said the reason is clear: we are neither mice nor flat layers of cells.

“Most drugs fail clinical trials, and I think it's pretty easy to appreciate that we are neither mice nor flat layers of cells.”

How Intero ships its product

Intero's flagship product, GastroScreen, is a human intestinal organoid model about one millimeter across. The company ships roughly one hundred at a time in a tube to pharmaceutical, biotech, food, and chemical companies.

“We're literally shipping mini living organs in the mail to people.”

What customers can do with organoids

Customers use organoids as healthy intestinal models or induce disease-like conditions to test how tissue responds to different compounds. Intero also sells nutrient mixes, chemicals for experiments, and runs custom studies for clients.

Intero's business so far

Founded in two thousand twenty-four, Intero has seven employees and just under ten customers after raising two point three million dollars in a pre-seed round last year.

FDA pushes alternatives to animal testing

In April of last year, the U.S. Food and Drug Administration laid out plans to reduce reliance on animal testing in drug development, promoting organoids, organs-on-chips, and AI-based computational models as potential alternatives.

New FDA guidance on non-animal testing

In March of this year, the FDA issued draft guidance outlining how drug developers should validate new approach methodologies, or NAMs, which are non-animal testing methods.

Why pharma companies are now interested

Changes in U.S.law allowing drug developers to use non-animal testing methods in some cases have made pharmaceutical companies more willing to explore organoid technology.

How Intero differs from competitors

Intero's GastroScreen is derived from induced pluripotent stem cells, adult cells reprogrammed to become almost any cell type and generated from a blood sample.

Intero's validation progress

Intero is in the second stage of a three-stage validation process.It has shown GastroScreen contains key tissues of the human gut and now tests well-known drugs with documented effects in humans.

Intero's next steps and ambitions

Intero can currently make a few thousand organoids at a time and is working to automate manufacturing to produce hundreds of thousands per batch.