Billerica, Mass. — Javelin Biotech and Pfizer have published research showing that a multi-tissue chip platform can predict how small-molecule drugs behave in humans, potentially reducing reliance on animal testing during preclinical development.
The study, “Interconnected multi-microphysiological systems and PBPK modeling for predicting human pharmacokinetics,” was published in the “Breakthrough” special issue of Lab on a Chip.
The research evaluated Javelin’s liver-centered multi-tissue chip platform, which connects liver, kidney and skeletal muscle models in a recirculating microfluidic system. The platform is designed to simultaneously measure hepatic metabolism, renal excretion and volume of distribution.
“This work is a major achievement in the New Approach Methodologies (NAMs) space, proving that multi-MPS platforms can deliver accurate clinical predictions,” said Murat Cirit, Ph.D., Chief Executive Officer of Javelin Biotech. “Small molecules represent 50% of therapeutics in development today. On the first anniversary of the FDA Modernization Act 3.0, this study provides critical scientific evidence that the Javelin platform can deliver clinical predictions and accelerate development without the use of animal data.”
Researchers combined data generated by the chip platform with physiologically based pharmacokinetic models to predict drug exposure in humans.
Javelin said the resulting predictions showed a strong correlation with clinical data across all Extended Clearance Classification System categories, suggesting the platform could help researchers refine pharmacokinetic forecasts before beginning human trials.
“Pfizer remains committed to the 3Rs and to exploring innovative ways to enhance the predictive accuracy of our preclinical research,” said R. Scott Obach, Ph.D., Senior Research Fellow at Pfizer. “The results of this collaboration represent a significant step in bridging the gap between laboratory models and clinical reality. By showing how on-chip data can be integrated into PBPK models, we are building a deeper understanding of human-specific pharmacokinetics—a critical step in our ongoing efforts to refine our research models and reduce reliance on animal studies over time.”
The companies said the platform could provide a bridge between laboratory studies and clinical trials by enabling more human-relevant and data-driven predictions during drug development.
