Javelin Biotech today announced a landmark scientific publication, titled "Interconnected multi-microphysiological systems and PBPK modeling for predicting human pharmacokinetics”, in the "Breakthrough" special issue of Lab on a Chip. The study details a liver-centric multi-tissue chip (MTC) platform designed to capture the complex pharmacokinetic (PK) profiles of small-molecule drugs.

The research marks a significant demonstration of how combinatorial NAMs enable the translation of multi-MPS data into clinical exposure predictions. By integrating the liver MPS with kidney and skeletal muscle within a single, recirculating microfluidic environment, the platform allows for the simultaneous identification of 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.”

A core breakthrough of the study is the validation of these on-chip parameters through integration with Physiologically Based Pharmacokinetic (PBPK) models. The study demonstrated high correlation with human clinical data across all Extended Clearance Classification System (ECCS) classes, providing a scalable tool for researchers to refine predictions before entering 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.”

As the industry moves toward more efficient, data-driven methodologies, Javelin Biotech’s platform serves as a critical bridge between laboratory research and human clinical trials. This is a major achievement in the NAM space that multi-MPS platform can deliver accurate clinical predictions.

About Javelin Biotech

Born from MIT’s interdisciplinary ecosystem, Javelin is a leading biotechnology company providing cutting-edge organ-on-a-chip platforms that offer unparalleled fidelity and insight into human biology and disease states. Our technology generates high-quality, human-relevant data essential for robust AI/ML integration, accelerating the development of safer, more effective, and personalized therapeutics while reducing costs and the reliance on animal testing.

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"The results of this collaboration represent a significant step in bridging the gap between laboratory models and clinical reality."